HPV (Human Papilloma Virus) vaccine is used to prevent infection with certain types of human papillomavirus, which can cause chronic life threatening ailments like cervical cancer (cancer of cervix – lower part of uterus) and genital warts (wart-like growth on genitals). Medical authorities in various countries including United States recommend vaccination of young women against HPV. This may prevent genital warts, cervical cancer and other painful & expensive treatments of cervical dysplasia (abnormal cell growth on cervix), which can be caused by HPV strains.  The HPV vaccines currently available in the market are Merck’s Gardasil and GSK’s Cervarix.

Gardasil Vaccination is Associated with Serious Injury, including Nerve Damage

Other than risk of developing cervical cancer, there are various cases of Gardasil related injury reported in medical journals.  For example, the Journal of Child Neurology recently published an article about a 16-year-old-girl had lost her eye vision within 10 days of receiving the second course of the HPV vaccine. The event of loss of vision took place after girl child experienced a headache on the left side of her head after eight days of second HPV shot.  Later in a span of 48 hours, the pain stretched across her head and she lost her sight in both eyes.

Merck’s Fosamax (drug: Alendronate) is used to treat two bone disorders, osteoporosis in postmenopausal women and Paget’s disease. Osteoporosis causes a decrease in bone mass volume and reduction in bone strength leading to fracture of spine, wrist and hip. In Paget’s disease, healthy bone is deteriorated to poor quality bone resulting in many bone disorders.  Fosamax was the first of a class of drugs called bisphosphonates which gave women an alternative to traditional treatments for osteoporosis (estrogen (female sex hormone) and calcitonin).

The lawsuits claim that Fosamax causes osteonecrosis of the jaw.  Osteonecrosis is death of jawbone tissue due to poor blood supply to the jaw area. As on March 31 2010, close to 1,039 including approximately 1,417 plaintiff groups had been filed and were pending against Merck in either state or federal courts.

Merck states that they are responsible for the patient safety and hence enough patient safety data was collected from clinical trials and post marketing trials of Fosamax. These updates, Merck argued, were regularly provided to medical, scientific and regulatory communities and also sent to consumers.

Mrs. Boles’ alleged that she suffered from dead jaw and complications following two tooth extractions in June 2002. She was admitted to the hospital to treat her Fosamax related osteonecrosis.  Her treating doctor testified that Boles was unable to eat food and was “wasting away”. Doctors also indicated that she cannot orally consume the food and hence she will have to perform a surgery to remove a large section of her dead jaw bone and reconstruct her face.  Mrs. Boles’ used Fosamax from 1997 to 2006.

Merck has indicated that the company would appeal the jury’s decision as the compensation for damages were excessive and unjustified.

Avandia has been on the market for 11 years. The drug is widely used in US to control type 2 diabetes.  Avandia falls under the class of thiazolidinedione drugs and works by binding to specific receptors, PPAR in fat cells and making them more responsive to Insulin. GSK sells Avandia alone and in combination with metformin or glimepiride.

The controversy surrounding Avandia started in 2007 when FDA and European Medical Agencies flagged the drug for increased risk of heart attack, strokes and deaths in older adults. Despite many clinical trials to evaluate the cardiac safety of the drug the safety of Avandia is still in doubt.  Many researchers feel that this drug causes more deaths than Pioglitazone (Actos) and hence should be taken off from the market.

FDA panel reviewed an exhaustive 700 page document and voted 21 – 12 for keeping the drug in the market, but with change in drug label and associated warnings. Experts have insisted that patients should be educated by physicians about the risks & safety of Avandia. FDA group itself is widely divided on the case of Avandia and its potential health risk on patients. The agencies have decided to re-examine the product due to latest possibility and pressure from Captol Hill. There has also been a question on companies trust worthiness – as it is believed that the company officials had deliberately hid the safety data of the drug from FDA during drug approval process.

The European Medical Agencies planned for a review on market authorization of Avandia from July 19 to July 22. European ministry of Health and agency have formed a committee, Medical product for Human use who would be responsible to review the case of this drug. It is strongly believed that once FDA has made a decision on this drug, regulatory bodies & health authorities from other countries will also follow the same line.

Officials from GSK are confident on the drug and for the safety of the patients. They have always expressed that Avandia is an important treatment option for Type 2 diabetes patients. On the recent controversies, company officials have always worked with the respective Health authorities and medical agencies like European Medical Agencies and FDA for the best interest of the chronic disease and safety of the patients.

Market share and the prescription rate, both, for Avandia has decreased since 2007. GSK is also facing strong market competition for its diabetes portfolio. Post controversy, study revealed that this drug may induce adverse events like some damages in the eye, bone loss, and heart problems. Studies also indicated that Avandia does increase the risk of heart attack – up to 20 to 25 percent. But in the past, drugs have been withdrawn from the market having risk up to 200 – 300 percent.

Merck Inc., the maker of Gardasil, has undertaken an aggressive lobbying campaign to force families to subject their daughters to the vaccine. Our Gardasil injury lawyers are offering free consultations to anyone who suffered serious complications from Gardasil or their families. Our injury lawyers will work hard to make sure vaccine injury victims receive the compensation they deserve.

Gardasil injury lawyers working for our firm have been investigating reports of deaths, GBS, nerve damage and blood clots occurring in individuals after being immunized with the vaccine. As of June 30, 2008, 20 deaths had been reported to vaccine adverse event reporting system (VAERS). These deaths are still under investigation. Still, it has been widely reported that Gardasil is associated with GBS.

Guillain-Barre Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections. Finally, thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil.

Contact our Vaccine Injury Lawyers

At Law Offices of Sadaka Associates, we can assure you that if you are injured by a vaccine we will fight to get you the compensation you deserve. Our Vaccine Injury Lawyers are standing by to assist you. In most instances, with exception, you only have three years from the date of injury to file a claim in vaccine court or two years from the date of death. Contact our Vaccine Injury Lawyers today, toll-free, at 1-800-810-3457 or fill out our online form for a free case evaluation.

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FDA and CDC Report: Gardasil Continues to be Safe and Effective

Gardasil Vaccine Safety

August 20, 2009

Consumers, parents, health care professionals and others have raised questions regarding the safety of the human papillomavirus (HPV) vaccine, Gardasil. FDA and the U.S. Centers for Disease Control and Prevention (CDC) take all concerns about vaccine safety seriously, and have been closely monitoring the safety of Gardasil.

Below is a summary of Gardasil vaccine safety monitoring activities and findings. Based on ongoing assessments of vaccine safety information, FDA and CDC continue to find that Gardasil is a safe and effective vaccine. FDA and CDC continue to monitor the safety of this vaccine, with the public’s health and safety our top priority.

Gardasil Background

FDA approved Gardasil on June 8, 2006. It is approved for females 9-26 years of age to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. CDC’s Advisory Committee on Immunization Practices (ACIP) recommended a routine 3-dose vaccination series for girls 11 and 12 years of age. The vaccine is also recommended for girls and women ages 13 through 26 years who have not yet been vaccinated or who have not received all 3 doses.

Studies involving approximately 21,000 girls and women were conducted to evaluate the safety and effectiveness of Gardasil before receiving approval by FDA. Approximately half of the study participants received the vaccine, and the other half received a control. These studies showed that in women who have never been infected by HPV types 6, 11, 16 or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina and vulva, and in preventing genital warts caused by these HPV types.

This vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.

Monitoring the Safety of Gardasil

Vaccine Safety Overview

FDA and CDC closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS). VAERS receives unconfirmed reports of possible side effects following the use of Gardasil and all vaccines licensed in the U.S. VAERS reports are regularly reviewed for safety concerns or trends of adverse events (possible side effects).

Vaccines are manufactured in batches called lots. All vaccine lots are routinely tested and must pass all tests before they can be used, and vaccine manufacturers must comply with strict manufacturing standards. FDA also analyzes adverse events (possible side effects) associated with individual lots to look for any unusual patterns. No such patterns have been observed in FDA’s review of HPV vaccine lots since the vaccine was licensed.

In addition to VAERS, CDC has two other systems in place to monitor the safety of all licensed vaccines. The Vaccine Safety Datalink (VSD) Project is a collaborative effort between CDC and eight managed care organizations that monitors vaccine safety and addresses the gaps in scientific knowledge about rare and serious side effects following immunization. The Clinical Immunization Safety Assessment (CISA) Network is a collaboration with six academic centers in the United States to conduct clinical research on vaccine-associated adverse events.

Adverse Event Reports following Gardasil

Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations. Our monitoring and analysis of reports, including in-depth medical review, statistical data mining techniques, and analysis of reporting rates (number of adverse events/number of doses distributed) are designed to detect serious events that occur at rates greater than expected.

VAERS receives reports of many events that occur following immunization. Some of these events may occur coincidentally during the time period following vaccination, while others may actually be caused by vaccination. In our analysis of VAERS data, we look for patterns of adverse events that may be plausibly linked to a vaccine. Such patterns of adverse events may require further study.

On August 19, 2009, the Journal of the American Medical Association (JAMA) published an article coauthored by FDA and CDC that reviews the safety data for Gardasil for select adverse events that have been reported to VAERS, from the time period starting from product licensure in June 2006 through December 31, 2008 (JAMA. 2009;302(7):750-757). The article describes 12,424 reports of adverse events following Gardasil vaccination. Of these, 772 were reports of serious events (6.2% of the reports) and the remaining 11,652 (93.8%) were classified as non-serious. During this time period, the manufacturer, Merck and Co., has distributed over 23 million doses of Gardasil in the United States. The information contained in this update is based on the same information contained in the article published in JAMA. FDA will provide a future update to information on the number of reports of adverse events and doses distributed.

The Gardasil safety review assessed the following adverse events: local injection site reactions, syncope, dizziness, and nausea, headaches, hypersensitivity reactions, such as rashes, hives, itching, anaphylaxis, Guillain-Barré syndrome (GBS), transverse myelitis, motor neuron disease, venous thromboembolic events (VTEs), pancreatitis, autoimmune disorders, pregnancy, and deaths. All of these events are included in Gardasil’s labeling. In VAERS, a higher proportion of Gardasil reports were of syncope and VTEs compared with other vaccines. However, none of the adverse events in the safety review, including syncope and VTEs, were reported at rates (number of adverse events/number of doses distributed) greater than expected in a population of this age and gender and with other known contributing factors to these adverse events.

VAERS reports include syncope (fainting), pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after syncope may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. FDA and CDC have taken steps to remind immunization providers about the recommendation that individuals be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. FDA approved revised labeling on June 9, 2009, to highlight this information in the Warnings and Precautions section, and new information was added noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. As a part of a Back to School immunization campaign, FDA and CDC are also continuing to remind health care providers to take measures to prevent fainting and the possible traumatic injury resulting from fainting.

Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Most of these individuals had risk factors for blood clots such as use of oral contraceptives which are known to increase the risk of clotting. The JAMA article describes 56 cases, 31 of which were confirmed blood clot reports. Twenty eight reports (90%) had underlying known risk factors such as hormonal birth control, genetic clotting abnormalities, obesity, smoking, and immobility. In the CDC’s VSD, blood clots have not been found to occur more often than expected after over 450,000 doses of Gardasil.

Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of December 31, 2008, 32 deaths had been reported to VAERS. There was not a common pattern to the deaths that would suggest they were caused by the vaccine. In the majority of cases with available autopsy, death certificate and medical records, the cause of death was explained by factors other than the vaccine.

Guillain-Barre Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections. FDA and CDC have reviewed the reports of GBS that have been submitted to VAERS. To date, there is no evidence that Gardasil has increased the rate of GBS above that expected in the population. While we continue to carefully analyze all reports of GBS submitted to VAERS, the data do not currently suggest an association between Gardasil and GBS.

Because VAERS data are subject to many limitations of passive reporting systems, FDA and CDC also utilize additional surveillance tools. This includes the CDC’s VSD which incorporates eight large Managed Care Organizations, and now has health records linked to over 450,000 doses of Gardasil, and focuses on several potential risks: thrombotic events (blood clots), seizures, syncope, appendicitis, anaphylaxis, and GBS. Thus far, the VSD studies have not found safety signals or concerns for any of these events. The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine’s safety.

Summary

Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks. CDC has not changed its recommendations for use of Gardasil. FDA has not made any changes to the prescribing information for how the vaccine is used. In addition, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity and potency of Gardasil.

Public health and safety are priorities for FDA and CDC. As with all licensed vaccines, we will continue to closely monitor the safety of Gardasil. FDA and CDC continue to find that Gardasil is a safe and effective vaccine that will potentially benefit the health of millions of women by providing protection against the types of HPV in the vaccine that cause cervical, vulvar and vaginal cancer, genital warts, and other HPV-related genital diseases in females.

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Report from the CDC about Gardasil Safety

Reports of Health Concerns Following HPV Vaccination

HPV Vaccine Safety

The safety of the HPV vaccine was studied in 5 clinical trials before it was licensed. There were over 21,000 girls and women ages 9 through 26 in these clinical trials.

Since it was licensed, CDC and FDA have been closely monitoring the safety of the HPV vaccine. There are 3 systems used to monitor the safety of vaccines after they are licensed and being used in the U.S. These systems can monitor side effects already known to be caused by vaccines as well as detect rare side effects that were not identified during a vaccine’s clinical trials. The 3 systems are:

The Vaccine Adverse Event Reporting System (VAERS)–a useful early warning public health system that helps CDC and FDA detect possible side effects or adverse events following vaccination.

The Vaccine Safety Datalink (VSD) Project–a project between CDC and 8 health care organizations to study patterns in reports detected by VAERS and determine if a vaccine is causing a side effect.

The Clinical Immunization Safety Assessment (CISA) Network–a project between 6 academic centers in the U.S. which conduct research on adverse events that might be caused by vaccines.

Reports to VAERS Following HPV Vaccination

As of June 1, 2009, more than 25 million doses of Gardasil were distributed in the United States.

As of June 1, 2009, there were 14,072 VAERS reports of adverse events following Gardasil vaccination in the United States. Of these reports, 93% were reports of events considered to be non-serious, and 7% were reports of events considered to be serious.

Based on all of the information we have today, CDC continues to recommend Gardasil vaccination for the prevention of 4 types of HPV. As with all approved vaccines, CDC and FDA will continue to closely monitor the safety of Gardasil. Any problems detected with this vaccine will be reported to health officials, healthcare providers, and the public, and needed action will be taken to ensure the public’s health and safety.

Non-serious adverse event reports

VAERS defines non-serious adverse events as those other than hospitalization, death, permanent disability, and life-threatening illness.

The vast majority (93%) of the adverse events reports following Gardasil have been non-serious. Reports of non-serious adverse events after Gardasil vaccination have included fainting, pain and swelling at the injection site (the arm), headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented by closely observing the vaccinated person for 15 minutes after vaccination.

Serious adverse event reports

VAERS defines serious adverse events as adverse events that involve hospitalization, permanent disability, life-threatening illness, and death. As with all VAERS reports, serious events may or may not have been caused by the vaccine.

Please note: A major limitation of VAERS data is that there is no proven causal association between the vaccine and the adverse event. The only association is in time, meaning that the adverse event occurred sometime after vaccination. Therefore we cannot conclude that the events reported to VAERS were caused by the vaccine.

All serious reports (7%) for Gardasil have been carefully analyzed by medical experts. Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine. The following is a summary of selected serious adverse event reports that were submitted to VAERS between June 8, 2006 and June 1, 2009.

Guillain-Barré Syndrome (GBS)

Guillain-Barré Syndrome (GBS) has been reported after vaccination with Gardasil. GBS is a rare disorder that causes muscle weakness. It occurs in 1-2 out of every 100,000 people in their teens. A number of infections can cause GBS. There has been no indication that Gardasil increases the rate of GBS in girls and women above the rate expected in the general population, whether or not they were vaccinated.

Blood Clots

Rarely, people have reported blood clots after getting Gardasil. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill).

Deaths

As of June 1, 2009, there have been 43 U.S. reports of death among females who have received the vaccine. Twenty six of these reports have been confirmed, 9 are still under investigation, and 8 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. Confirmed reports are those that scientists have followed up on and have verified the claim. In the 26 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine.

More information is available at:

http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-oct08/12-3-hpv.pdf

Reports of adverse events after getting a vaccine can be submitted to VAERS by fax at 1-877-721-0366, online at https://secure.vaers.org/VaersDataEntryintro.htm, or by mail to Vaccine Adverse Event Reporting System, P.O. Box 1100, Rockville, MD 20849-1100.

Page last modified: June 18, 2009
Content source: Immunization Safety Office

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The following was posted by the FDA regarding the labeling revising for Gardasil:

Reminder to HealthCare Providers: 15-minute Observation Period Needed After Vaccination

On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. In the new label, information pertaining to syncope (fainting) is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries. To prevent falls and injuries all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination.

As with all vaccines, FDA closely monitors the safety of Gardasil. Syncope (fainting) has been in Gardasil’s labeling for both the healthcare provider and the patient since October 2007; however, FDA and the Centers for Disease Control and Prevention (CDC) continue to receive reports of traumatic injuries of individuals fainting and falling after receiving Gardasil. Some who fainted have had serious injuries from falling, which have often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents. Therefore, FDA requested the manufacturer, Merck and Co., Inc., to add this information to the Warnings and Precautions section of the label, so that it is more prominent, and reminds healthcare providers that recipients of Gardasil should be closely observed for 15 minutes after vaccination. Gardasil recipients should be encouraged to remain seated or lying down for this length of time and be alert to the following warning signs and symptoms that may happen before a person faints: paleness, sweating, dizziness, ringing in ears or vision changes.

Syncope has been reported after administration of other adolescent and adult vaccines, so it is not unique to Gardasil or even vaccines. Syncope can also occur with certain medications, after blood donation, or in response to pain. Jerking movements, loss of bladder control, and other signs that resemble epileptic seizures may occur with fainting, but do not mean that the person is having epilepsy. New information in the Warnings and Precautions section alerts healthcare providers that tonic-clonic (jerking) movements and seizure-like activity can occur with fainting. Syncope and its associated signs and symptoms generally last only a short time (seconds to minutes) and resolve when the patient is placed in a position, such as lying down, to restore adequate blood flow to the brain.

A Morbidity and Mortality Weekly Report published in May 2008 recommends that all providers administering vaccinations should be aware of the potential for syncope after vaccination and should take appropriate measures to prevent potential injuries. As part of our ongoing surveillance of vaccine safety, FDA is evaluating whether changes to the labeling concerning this particular side effect are needed for other adolescent and adult vaccines. FDA and CDC are also in the process of reviewing the Vaccine Information Statements (VISs) to include syncope. These information sheets explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal Law requires that VISs be handed out whenever (before each dose) certain vaccinations are given.

Key Facts:

Healthcare providers and consumers should be aware that syncope (fainting) may occur following vaccination with Gardasil, sometimes resulting in falling and traumatic injuries. These falls and injuries are preventable by having Gardasil recipients remain seated or lying down for 15 minutes following vaccination, closely observing them, and watching for the following warning signs and symptoms: paleness, sweating, dizziness, ringing in ears or vision changes, which generally occur before fainting. If an individual faints, and especially if seizure-like activity occurs, the individual should be placed in a position, such as lying down to help restore blood flow to the brain.
FDA has received reports to the Vaccine Adverse Event Reporting System (VAERS) of syncope, as well as, syncope with tonic-clonic (jerking) movements and seizure-like activity that occurred after Gardasil and other vaccinations. Of all of the reports in VAERS pertaining to Gardasil, approximately 13% describe syncope. The percentage is similar to reports of syncope for other adolescent vaccines.

The VAERS is a national vaccine safety surveillance program co-sponsored by the FDA and the CDC. The purpose of VAERS is to detect possible signals of adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of US licensed vaccines.

In 2007, FDA and CDC did a comprehensive review of VAERS reports of syncope and related medical charts after adolescent vaccination. The review found that 30-40% of adolescent syncope reports described signs of jerking or other seizure-like activity, approximately 20% described traumatic injury, and 95% occurred within 15 minutes of vaccination.

Since syncope was added to the label in 2007, we continue to receive a consistent number of reports of syncope and traumatic injuries resulting from it. Because the number of reports has not declined, this reminder to healthcare providers emphasizes that preventive measures are warranted.
Syncope has been reported after administration of other adolescent and adult vaccines, so it is not unique to Gardasil or even vaccines. Syncope can also occur with certain medications, after blood donation or in response to pain and the following may occur: jerking movements, loss of bladder control, and other signs that resemble epileptic seizures, but is not epilepsy.

Gardasil is an important tool for the prevention of cervical, vulvar and vaginal cancers and genital warts that will benefit the health of millions of women. HPV types 16 and 18 cause approximately 70 percent of cervical cancers, and HPV types 6 and 11 cause approximately 90 percent of genital warts. According to the National Cancer Institute, in 2009 there will be approximately 11,000 new cases of cervical cancer and 4,000 deaths in the United States. Gardasil will not treat existing diseases caused by HPV types contained in the vaccine and it is important that vaccination with Gardasil occurs before exposure to HPV infection. Females who receive Gardasil should continue to undergo regular pap tests for cervical cancer screening.

Since it was licensed, FDA and CDC have been closely monitoring the safety of Gardasil.

Based on ongoing assessments of vaccine safety information gathered from various surveillance tools, FDA and CDC continue to find that Gardasil is a safe and effective vaccine, and that its benefits continue to outweigh its risks. As part of our ongoing surveillance of vaccine safety, FDA is evaluating whether changes to the labeling concerning syncope are needed for other adolescent and adult vaccines.

Law Offices of Sadaka Associates is filing lawsuits on behalf of women who suffered heart attacks, cardiac arrhythmias, blood clots, deep vein thrombosis (DVT), pulmonary embolism (PE), strokes, gallbladder disease, hepatic adenomas or benign liver tumors, and other serious injuries and sudden death.

What is Yaz, Yasmin and Ocella?

Yaz and Yasmin are the trade names for birth control pills manufactured by Bayer Healthcare Pharmaceuticals, Inc. Like most birth control pills, they contain a mixture of estrogen and progestin. Unlike most birth control pills, however, Yaz and Yasmin use a different type of progestin in combination with low dose estrogen.

Ocella is the generic form of Yaz and Yasmin and is manufactured by various generic drug manufacturers.

What is the problem with Yaz, Yasmin and Ocella?

The controversy surrounding Yaz, Yasmin and Ocella focuses on two points. The first is the products’ use a unique type of progestin that has been linked to excess elimination of urine leading to dehydration. The second is misleading direct-to-consumer advertising.

Birth Control Blood Clots

Birth control has long been associated with an increased risk of blood clots. Indeed, the risk of birth control related blood clots is in the warning label for all birth control drugs.

What is alleged to be different with Yaz, Yasmin and Ocella is the use a unique type of progestin that has been linked to excess elimination of urine leading to dehydration. Dehydration can cause an electrolyte imbalance in body leading to heart attack and arrhythmia. Dehydration can also increase the risk of the formation of blood clots.

Types of Birth Control Related Blood Clots

DVT Blood Clots

DVT or Deep Vein Thrombosis is a blood clot that is formed in the “deep veins” of the leg or arm. The blood clot blocks blood flow to the area and can cause a great deal of pain. In some instances, the DVT blood clots can dislodge and form blood clots in the lung (pulmonary embolism).

Blood Clots in the Lung

Blood clots in the lung or pulmonary embolism is a serious, life-threatening condition. What happens is that a blood clot forms in the the vein that leads from the heart to the lung blocking blood delivery. If the blockage is severe enough or untreated this can lead to death. The blood clot can start as a DVT blood clot ad travel to the lung or it can form directly in the lung.

Birth Control Related Stroke

Finally, birth control is related to an increased risk of stroke. Birth control related stroke can have long lasting effects on speech, hearing and cognitive function.

Misleading Advertising: Aren’t all Birth Control Pills Associated with a Risk of Blood Clots?

Yes. All birth control pills carry some risk of blood clots. However, on October 3, 2008, Bayer Healthcare Pharmaceuticals, Inc. received a warning letter from the FDA about misleading advertising (see reprint of the warning letter below). Why was the advertising misleading? Because Bayer downplayed the true risks of Yaz and Yasmin, making those pills appear safer than other brands when they carried the same if not greater risk of blood clots.

Contact Law Offices of Sadaka Associates for a Free Legal Consulation

If you or a loved one took the birth control Yaz, Yasmin or Ocella and suffered a blood clot then contact our lawyers today for a free legal consultation. Fill out our online form or call us at 1-800-810-3457.

FDA Warning Letter (10/3/2008)

Bayer HealthCare Pharmaceuticals, Inc. 03-Oct-08
Department of Health and Human Services
Public Health Service
Food and Drug Administration

Silver Spring, MD 20993

TRANSMITTED BY FACSIMILE
Reinhard Franzen
President & Chief Executive Officer
Bayer HealthCare Pharmaceuticals, Inc.
P.O. Box 1000
Montville, NJ 07045-1000

Re: NDA #21-676, 21-873, 22-045
YAZ® (drospirenone and ethinyl estradiol) Tablets
MACMIS ID# 16473

WARNING LETTER

Dear Mr. Franzen:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed two 60-second direct-to-consumer (DTC) broadcast television advertisements (TV Ads) entitled “Not Gonna Take it” (ZYRA-6323) and “Balloons” (ZYRA-6567) for YAZ® (drospirenone and ethinyl estradiol) Tablets (YAZ) submitted by Bayer HealthCare Pharmaceuticals, Inc. (Bayer) under cover of separate Forms FDA-2253. The TV Ads are misleading because they broaden the drug’s indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug. Thus, the TV Ads misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), 352(f)(1) & 321(n), and FDA’s implementing regulations. 21 CFR 201.100(c)(1); 201.128; 202.1(e)(5)(iii) & (e)(6)(i). These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.

Background

According to the INDICATIONS AND USAGE section from the FDA-approved product labeling (PI), YAZ is approved for the following indications (in pertinent part):

[F]or the prevention of pregnancy in women who elect to use an oral contraceptive….

[F]or the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not been evaluated.

The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.

YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS) [emphasis added].

[F]or the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Additionally, the BRIEF SUMMARY PATIENT PACKAGE INSERT and DETAILED PATIENT PACKAGE INSERT state that:

… YAZ has not been shown to be effective for the treatment of premenstrual syndrome (PMS), a less serious cluster of symptoms occurring before menstruation. If you or your healthcare provider believes you have PMS, you should only take YAZ if you want to prevent pregnancy; and not for the treatment of PMS….

The PI for YAZ includes a BOXED WARNING that states (in pertinent part):

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Additionally, there are numerous warnings associated with the use of YAZ including, but not limited to, venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension.

Moreover, YAZ has additional risks because it contains the progestin, drospirenone. Drospirenone has antimineraloco rticoid properties which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking YAZ must be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives. This additional risk is described in the bolded WARNINGS section of YAZ’s PI.

Broadening of Indication
Premenstrual Dvsghoric Disorder (PMDD)
“Not Gonna Take It” (ZYRA-6323) & “Balloons” (ZYRA-6567)

The TV Ads misleadingly suggest that YAZ is effective in a broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience. Specifically, given the overlap in certain symptoms between premenstrual syndrome (PMS) and PMDD, and the material limitation on YAZ’s PMDD indication (that it has not been evaluated for the treatment of the less serious condition, PMS), the TV Ads misleadingly suggest that YAZ is appropriate for treating women with PMS, who may not be appropriate candidates for this drug. We note that despite listing certain symptoms of PMDD, nowhere do the TV Ads use the full phrase “premenstrual dysphoric disorder,” to more completely distinguish PMDD from PMS, thereby increasing the likelihood that a viewer, in light of the claims and presentations described below, will understand it to be the same as, or substantially similar to, PMS.

The TV Ad ” Not Gonna Take It” starts by stating:
• “We all know that birth control pills are 99% effective and can give you shorter, lighter periods. But did you know there’s a Pill that could do more?”

It then displays images of energetic, euphoric, playful women singing “We’re Not Gonna Take It” as they kick, punch, and push words describing symptoms such as “IRRITABILITY,” “MOODINESS,” “BLOATING,” and “FEELING ANXIOUS,” away from the screen, followed by the claim “It’s YAZ! And there’s no other birth control like it.” The screen then displays a listing of symptoms including: irritability; increased appetite; moodiness; fatigue; feeling anxious; headaches; bloating; and muscle aches.

Similarly, the TV Ad “Balloons” starts by stating:
• “All birth control pills are 99% effective and can give you shorter, lighter periods. But there’s one Pill that goes beyond the rest. It’s YAZ.”

It then displays numerous balloons throughout the ad with symptoms, such as, “IRRITABILITY,” “MOODINESS,” “FEELING ANXIOUS,” “BLOATING,” “FATIGUE,” “MUSCLE ACHES,” “HEADACHES,” “INCREASED APPETITE,” and “ACNE.”

The symptoms displayed in these ads are commonly seen in women with PMS, which is a less serious and more common condition than PMDD. PMDD is a disorderwhose hallmarks include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features of PMDD include decreased interest in usual activities, difficulties concentrating, lack of energy, change in appetite or sleep, and feeling out of control. As discussed in the PI, for a diagnosis of PMDD:

… the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to the DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.

The TV Ads entirely omit the material limitation from the PI of the drug’s PMDD indication – i.e., that “YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS)” and fail to convey that the drug is only indicated for women who experience the symptomspresented to such a degree that they have PMDD, rather than PMS. As a result of the failure to convey these material facts, and the failure to explain what PMDD is, in contrast to PMS, the TV Ads misleadingly suggest that YAZ is approved to treat women with any severity of the symptoms presented, regardless of whether their symptoms are actually severe enough to constitute PMDD.

We note that the list of symptoms displayed in the TV Ads are accompanied by the text “YAZ treats PMDD” along with a SUPER reading “PMDD is a mood disorder related to the menstrual cycle.” However, these disclosures do not suffice to communicate the material fact that YAZ is not approved for treatment of PMS or to overcome the implication created by the totality of the visuals and images in the ads that YAZ is appropriate for any woman who experiences the symptoms presented. We also note that the voiceover states that “YAZ is the only birth control pill proven to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life.” However, this claim also fails to communicate that YAZ is not approved for treatment of PMS, and fails to distinguish, between PMS and PMDD.

The totality of the visual and audio presentations in both TV ads suggest that YAZ is approved to treat women with any severity of the symptoms presented, including women with PMS, when this is not the case. Thus, the TV Ads misleadingly broaden the indication of the drug.

Acne

In addition, the TV Ads suggest that YAZ is approved for acne of all severities when this is not the case. Specifically, in “Not Gonna Take it,” the word “ACNE” appears in large print in the middle of the screen along with the audio claim “It can also help keep your skin clear,” which is accompanied bya close-up visual of a woman with completely clear skin. Similarly, in “Balloons,” the “ACNE” balloon is prominently displayed on the screen, as it floats by a smiling woman with obviously clear skin, along with the audio claim that YAZ ” … also helps keep skin clear.” These presentations fail to adequately convey that, as noted in the PI, “YAZ is indicated for the treatment of moderate acne vulgaris …” (emphasis added). While the TV Ads do include a SUPER which refers to “improvement in … moderate acne” in small, unbolded print, this does not mitigate the misleading impression created by the prominent audio and visual claims in the TV Ads that YAZ is indicated for acne of all severities. Overstatement of Efficacy

PMDD
“Balloons” (ZYRA-6567)

The TV Ad is misleading because it suggests that YAZ is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The totality of the audio and visual claims and presentations misleadingly suggests that treatment with YAZ will allow women to say “good-bye” to their symptoms completely. For example, the TV Ad’s theme song “Good-Bye to you” plays in the background as energetic, euphoric, playful women release balloons into the air displaying certain symptoms (e.g., irritability, moodiness, feeling anxious, bloating, fatigue, muscle aches, headaches, increased appetite, and acne). The balloons then float up and away from the women misleadingly suggesting that these women are saying, ” goodbye” to their symptoms and are now symptom-free, when such an elimination of symptoms has not been demonstrated by substantial evidence or substantial clinical experience. According to the PI, in the primary clinical trial that served as the basis for approval of YAZ in the PMDD population, ” . . .the average decrease (improvement) from baseline was 37.5 points in women taking YAZ, compared to 30.0 points in women taking placebo” (added emphasis). These results do not support the implication that YAZ will result in a complete cessation of PMDD symptoms.

Acne
“Not Gonna Take It” (ZYRA-6323) & “Balloons” (ZYRA-6567)

The TV Ads include close-up images of women with completely clear, acne-free skin. In the TV Ad ” Not Gonna Take It,” there is an image of a woman with the word “ACNE” prominently displayed on the screen before the word “ACNE” fades away from view. The woman turns her face to the side showing viewers that she has no visible signs of acne on her face, in conjunction with the audio claim “It can also help keep your skin clear.” In “Balloons,” a woman with obviously clear skin smiles and acknowledges the ” ACNE” balloon as it floats away from the center of the screen and disappears into the sky, in conjunction with, the background song ” Good-bye to you” and the audio claim that YAZ ” . . .also helps keep skin clear.” The overwhelming impression conveyed by the TV Ads is that treatment with YAZ results in clear, acne-free skin for those women suffering from acne when this has not been demonstrated by substantial evidence or substantial clinical experience. As illustrated by Table III in the PI, the percentage of subjects assessed by the Investigator’s Static Global Assessment (ISGA) with a ‘clear’ or ‘almost clear’ rating at day 15 of cycle 6 was 15% and 21 % for subjects receiving YAZ versus 4% and 9% of placebo subjects in Studies 1 and 2, respectively. Furthermore, the mean percent reduction of total lesions at day 15 of cycle 6 was 42% and 46% for subjects receiving YAZ versus 25% and 31 % of placebo subjects in studies 1 and 2, respectively. Although these results are significant, they do not demonstrate that YAZ results in clear, acne-free skin for a typical woman; rather, these results demonstrate that it reduces the amount of acne lesions more than placebo but does not result in completely clear skin for these women. Thus, the TV Ads misleadingly overstate the efficacy of the drug.

Minimization of Risk
“Not Gonna Take It” (ZYRA-6323) & “Balloons” (ZYRA-6567)

The audio communication of serious risk disclosures during the “major statement” is minimized by distracting visuals, numerous scene changes, and other competing modalities such as the background music which combine to interfere with the presentation of the risk information. In “Not Gonna Take It”, the fast-paced visuals depict various women looking at pictures, trying on clothes, chatting at a cafe, stretching/exercising in a park, and walking down the street while the audio component describes the major risks associated with YAZ. Similarly, in “Balloons,” the background music plays as fast-paced visuals depict various women running in a park, sitting on a scenic waterfront, smiling, walking out of a coffee shop, driving and singing, walking out on a balcony, using an elevator, walking through the street to join friends, in addition, to a pigeon on a building ledge and balloons being released and floating away. These complex presentations distract from and make it difficult for viewers to process and comprehend the impo rtant risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life-threatening. The overall effect of the distracting visuals, graphics, concurrent supers and background music is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.

Conclusion and Requested Action

For the reasons discussed above, the promotional piece misbrands YAZ in violation of the Act, 21 U.S.C. 352(n), 352(f)(1), & 321(n), and FDA implementing regulations. 21 CFR 201.1 00(c)(1); 201.128; 202.1 (e)(5)(iii) & 202.1(e)(6)(i).

DDMAC asks Bayer to immediately cease dissemination of violative promotional materials for YAZ that are the same as or similar to those described above. Please submit a written response to this letter on or before October 20, 2008, describing your intent to comply with this request, listing all promotional materials for YAZ that are the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Because the violations described above are serious, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials. Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266, facsimile at (301) 847-8444. In all future correspondence regarding this matter, please refer to MACMIS ID # 16473 in addition to the NDA number(s). If you choose to revise your promotional materials, DDMAC is willing to assist you with your revised materials by commenting on your revisions before you use them in promotion. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for YAZ comply with each applicable requirement of the Act and FDA implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.

Sincerely,
{See appended electronic signature page}
Thomas Abrams, R.Ph., M.B.A.
Director
Division of Drug Marketing,
Advertising, and Communications
This is a representation of an electronic record that was signed electronically and this page is the manifestation of the elec tronic signature.
/s/
Thomas Abrams
10/3/2008 04:31:08 PM

Our vaginal mesh injury lawyers are investigating serious injury, including erosions and infections, caused by the implantation of vaginal surgical mesh for the treatment of urinary incontinence. Our surgical mesh injury lawyers are reviewing and filing vaginal tape lawsuits. If you or a loved one was hurt by the implantation of vaginal surgical mesh contact one of our surgical mesh injury lawyers for a free case evaluation.

Quick View: Signs and Symptoms of Problems with Your Vaginal Surgical Mesh

-vaginal Pains and Bleeding

-vaginal discharge

-vaginal infections resulting from impaired healing

-extrusion of the vaginal surgical mesh (the mesh is “coming out” of the vagina),

-pain during intercourse, and

-urinary tract erosion

Vaginal Mesh, Vaginal Slings, Vaginal Tape?

There is a lot of confusion as to what is the proper name of the type of surgical mesh used in the treatment of stress urinary incontinence. This is because there are many different types of products in the market place. As a result of the different variations of the product many women do not know which type of surgical mesh was implanted.

Some of the popular names of the surgical mesh are as follows: vaginal mesh, vaginal slings, vaginal tape. Whatever it is that your doctor calls it, the simple fact is that all the products are made our of some sort of surgical mesh. As to whether the product is considered vaginal mesh, vaginal slings or vaginal tape really depends on the type of surgical mesh used and the place where the the mesh is implanted.

What is Urinary Incontinence?

Stress Urinary Incontinence (SUI) is a condition which affects approximately 13 million people in the United States, predominantly women. This highly prevalent medical condition remains underdiagnosed and underreported due to its embarrassing nature and social stigma. Female stress urinary incontinence occurs when the pelvic muscles which support the bladder and urethra are weakened; resulting in loss of bladder control. Typically, patients complain of involuntary urine loss during coughing, laughing, and sneezing and their incontinence becomes worse during high impact sports activities.

It is estimated that 50-70% of females with urinary incontinence fail to seek medical evaluation and treatment. Of individuals with urinary incontinence, only 5% in the general community and 2% in nursing homes receive appropriate medical evaluation and treatment. Patients with urinary incontinence often endure this condition for 6-9 years before seeking medical therapy.

For those women who have the resolve to overcome the embarrassment of seeking treatment for this condition, help is available in the form of a “vaginal mesh”, like the Bard Avaulta surgical mesh, which is inserted into the urethra via a medical procedure. Stress urinary incontinence has emerged as such a highly prevalent medical condition that a large and competitive marketplace for commercially viable solutions has emerged. From this demand vaginal surgical mesh like the “Bard Avaulta” mesh was born.

What is vaginal surgical mesh?

Vaginal surgical mesh is manufactured to surgically treat female urinary incontinence. The mesh, like the Bard Avaulta surgical mesh, is an artificial structure that is designed to replace eroded or weakened muscles in the urethra. When implanted, women were supposed to experience relief from their condition, what many received instead was an alarming, violent reaction to the device that lead to a plethora of medical issues.

Vaginal surgical mesh linked to erosion, infections

There are an estimated 35,000 women who suffered through bladder control problems brought on by aging, child birth, and a variety of other causes. The lives of those who had adverse reactions to Bard Avaulta mesh were literally ruined as many experienced crippling pain and permanent scarring damage from the procedures involved in the insertion and necessary removal of the vaginal tape.

Many women experienced debilitating pain as their bodies rejected the vaginal mesh, eventually these women were forced to undergo multiple surgeries to address the complications of their condition and sustained permanent injury. Ultimately, vaginal tape failed to cure their female urinary stress incontinence and caused additional medical complications.

Users of vaginal mesh, like Bard Avaulta surgical mesh, presented to their physicians with extreme vaginal pains and bleeding, vaginal discharge, and infections resulting from impaired healing, vaginal extrusion of the mesh and urinary tract erosion.

Surgical vaginal mesh erosion

Vaginal mesh, like the Bard Avaulta surgical mesh, can erode either into the vagina, or worse, into the urethra or bladder. When this happens surgery is a must because it can cause a lot of problems including chronic infections or a cut off of circulation.

Signs and symptoms of vaginal surgical mesh erosion

If you have any of the following symptoms of mesh erosion you need to go see your surgeon to have another evaluation and possible removal: malodorous vaginal discharge, vaginal pains and bleeding, pain with intercourse, recurrent bladder infections, or generalized pain.

Legal Help for Victims of Vaginal Mesh Erosion, Organ Damage or Infections

If you or someone you love are among the tens of thousands of women who had a vaginal surgical mesh, like the Bard Avaulta surgical mesh, implanted contact Law Offices of Sadaka Associates for a free evaluation today!

FDA Issues Warning to Doctors in October 2008

Dear Healthcare Provider:

This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.

Nature of the Problem

Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

Recommendations

Physicians should:

Obtain specialized training for each mesh placement technique, and be aware of its risks.

Be vigilant for potential adverse events from the mesh, especially erosion and infection.

Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.

Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.

Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).

Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

Additional patient information can be found on the following FDA Consumer website at http://www.fda.gov/cdrh/consumer/surgicalmesh-popsui.html.

Reporting Adverse Events to FDA

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of surgical mesh, you should follow the reporting procedure established by your facility.

We also encourage you to report adverse events related to surgical mesh that do not meet the requirements for mandatory reporting. You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-FDA-1088, or obtain the fillable form online at www.fda.gov/MedWatch/getforms.htm, print it out and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

Getting More Information

If you have questions about this notification, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.

FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through e-mail each time a new Public Health Notification is added to our web page. To subscribe to this service, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39 .

Sincerely,

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration

Looking Into Problems With Transvaginal Surgical Mesh

By Nasrin Mirsaidi, RN, CNOR, MSN

(Article reprinted from July Nursing2009, Volume 39, Issue 7)

A PATIENT, 67, had a transvaginal repair with synthetic mesh for pelvic organ prolapse. Four weeks later, she reported spotting, discomfort, and vaginal irritation. The surgeon found that the surgical mesh had eroded into her vagina and prescribed estrogen cream for a month, but it wasn’t effective. The patient needed more surgery for resection of the exposed mesh and closure of eroded tissue.

Pelvic organ prolapse and stress urinary incontinence are pelvic disorders affecting millions of women in the United States.1 They occur when pelvic floor muscles lose strength, allowing pelvic organs, including the bladder and uterus, to descend from their normal location and bulge through the vaginal wall (pelvic organ prolapse), or diminishing bladder control (stress urinary incontinence).1,2

Treatment options for pelvic organ prolapse or stress urinary incontinence include several surgical and nonsurgical approaches. Transvaginal placement of mesh has become increasingly popular in recent years.3

What’s the problem?

In the last 3 years, the FDA has received over 1,000 adverse event reports about mesh used in transvaginal surgical repair of pelvic organ prolapse and stress urinary incontinence. These reports include problems such as pain, infection, mesh erosion (into vagina, bowel, and bladder), and recurrence of prolapse or incontinence. Some reports involved rare but serious intraoperative injuries such as bowel, bladder, or blood vessel perforation. Most patients described in the adverse event reports needed medical or surgical intervention, and some required hospitalization.4

Although the exact cause of these adverse events hasn’t been identified, they’re likely to be the result of multiple factors. Further investigation is needed.

What precautions can you take?

Although treatment with mesh may have helped many women, in others it’s caused complications affecting quality of life.3,4 A literature review demonstrates conflicting information on success rates for transvaginal mesh placement, but everyone agrees on the need for controlled trials.5 If you care for a patient undergoing a transvaginal mesh placement procedure, consider this advice:

Become familiar with the types of mesh and procedures used for the repair of pelvic organ prolapse and treatment of stress urinary incontinence.

Ensure that your patient has given her informed consent. Make sure she’s received appropriate information about her choice of treatment, the type of procedure she’s undergoing, and possible adverse events.

During preoperative teaching sessions, tell your patient about possible adverse reactions, the signs and symptoms of infection, and when to notify her healthcare provider.

If you’re an OR nurse, follow your facility’s policies and procedures for recording information about implanted materials. Record the name of the mesh used and its catalog number, lot number, and size in the patient’s medical record.

Provide your patient with a written copy of the patient labeling from the surgical mesh manufacturer, if it’s available.

If your patient has surgery to remove mesh, follow your facility’s policies and procedures for properly handling the explanted mesh. Additionally, follow your facility’s policies and procedures for reporting adverse events.

For further information, refer your patient to this FDA Web site.

REFERENCES

1. Weber AM, Richter HE. Pelvic organ prolapse. Obstet Gynecol. 2005;106(3):615-634.

2. Fultz NH, Burgio K, Diokno AC, Kinchen KS, Obenchain R, Bump RC. Burden of stress urinary incontinence for community-dwelling women. Obstet Gynecol. 2003;189(5):1275-1282.

3. Mistrangelo E, Mancuso S, Nadalini C, Lijoi D, Costantini S. Rising use of synthetic mesh in transvaginal pelvic reconstructive surgery: a review of the risk of vaginal erosion. J Minim Invasive Gynecol. 2007;14(5):564-569.

4. FDA Public Health Notification: Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. October 20, 2008.

5. Slack A, Jackson S. Advances in the surgical management of prolapse. Menopause Int. 2007;13(1): 38-43.

Although you need to support your healthcare facility’s adverse event—reporting policy, you may voluntarily report a medical device that doesn’t perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178) or online.

Diane Dwyer, RN, BSN, who coordinates Device Safety, is a nurse consultant at the Center for Devices and Radiological Health at the FDA in Rockville, Md.

Nasrin Mirsaidi is a nurse consultant for general and plastic surgery devices at the Center for Devices and Radiological Health.

]]> http://www.pharmawatchdog.com/vaginal-mesh-lawsuits-claim-serious-erosion-organ-damage-and-infections/feed/ 0 http://www.pharmawatchdog.com/exjade-receives-black-box-warning/ http://www.pharmawatchdog.com/exjade-receives-black-box-warning/#comments Mon, 08 Mar 2010 04:48:23 +0000 Sadaka Associates http://www.pharmawatchdog.com/exjade-receives-black-box-warning/ Novartis Oncology and FDA notified healthcare professionals about recent changes in the Prescribing Information (PI) for Exjade, indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. New language was added to the Contraindications, Warnings and Precautions, and Drug Interactions sections of the PI, including a Boxed Warning, that the product may cause:

• renal impairment, including failure
• hepatic impairment, including failure
• gastrointestinal hemorrhage

In some reported cases, these reactions were fatal. These reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes, underlying renal or hepatic impairment or low platelet counts. Exjade therapy requires close patient monitoring, including measurement of serum creatinine and/or creatinine clearance as specified in the PI and serum transaminases and bilirubin as specified in the PI.

Click here to see the “Dear Healthcare Professional Letter”

Use: Automated peritoneal dialysis (PD) systems are prescription medical devices used to treat pediatric and adult patients with kidney failure.
In PD, a soft tube called a catheter is used to fill the abdomen with a cleansing liquid called dialysis solution. The walls of the abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from the blood into the dialysis solution. These wastes and fluid then leave the body when the dialysis solution is drained. Several fill – drain cycles are typically needed during a treatment. Automated PD systems, like the HomeChoice systems, can be programmed to deliver and remove several cycles of doctor-prescribed amounts of dialysis solution.
HomeChoice systems are used in conjunction with Baxter’s single use disposable tubing sets and bags of dialysis solutions.
The HomeChoice PRO model also has a small electronic data card, called a PRO card, which stores information from the nurse or doctor and automatically sets up the system for the patient.
Recalling Firm:
Baxter Healthcare Corporation
One Baxter Way
Deerfield, IL 60015
Reason for Recall: Baxter is conducting a recall of the HomeChoice and HomeChoice PRO because of reports of serious injuries and at least one death associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. IIPV can cause serious breathing and heart problems that can result in serious injury or death.
Public Contact: If you need assistance with your HomeChoice or HomeChoice PRO, call the Baxter Customer Service line, available 24 hours and day, 7 days a week at 1-800-553-6898.
FDA District: Chicago
FDA Comments:
Although Baxter is not removing the HomeChoice and HomeChoice PRO from the market, clinicians should weigh the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy. Clinicians should also review the prescription settings for patients who continue to use these devices.

IIPV may result in serious injury or death from conditions including but not limited to: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.

Children and non-verbal patients may be at increased risk because of their smaller size or inability to communicate. Increased monitoring of these patients is recommended.

Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.
Patients and caregivers should watch for the potential signs of IIPV. If patients or caregivers notice any of the signs of IIPV, stop the device, initiate manual drain, and contact your doctor immediately. Please refer to the Baxter press release, for a list of signs and symptoms of IIPV and more specific instructions for what to do if symptoms appear.

Any adverse reactions experienced with the use of this product or quality problems should be reported to the Baxter Renal Division at 1-888-736-2543, prompt 3 (Corporate Product Surveillance), and the FDA’s MedWatch Program by phone at 1-800-FDA-l088.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

* Influend Cold and Cough, 24 Tablets, Product Code/ Lot # 800074
* Influend Severe Cold & Flu, 24 Tablets, Product Code/Lot# 800075
* Influend JR. Cold & Cough, 4 oz. bottle, Product Code/Lot# 800076
* Influend JR. Severe Cold & Flu, 4 oz. bottle, Product Code/Lot# 800077

While no illnesses have been reported to date, ION Labs, Inc. has ceased distribution of these products until further notice.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.

ION Labs, Inc.
115th Ave. N.
Clearwater, Fl. 33760

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at the MedWatch website at www.fda.gov/medwatch

Consumers who have questions about the above recall may contact ION Labs Customer Service at 1-877-990-4466 and ask for the Quality Director at Ext. (212). Hours of operation are M-F from 8 a.m. to 5 p.m. EDT.

April 2, 2009

The Honorable Barack H. Obama
President of the United States
1600 Pennsylvania Avenue NW
Washington, DC 20500

Dear Mr. President:

The purpose of this letter is to draw your attention to the frustration and outrage that FDA physicians and scientists, public advocacy groups, the press, and the American people, have repeatedly expressed over the misdeeds of FDA officials. Recent press reports revealed extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA. As a result, Dr. Frank M. Torti, Acting Commissioner and the FDA’s first Chief Scientist, abruptly left the Agency. But, the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.

On Monday, March 30, 2009, Dr. Joshua Sharfstein, newly appointed Principal Deputy Commissioner, assumed the position of Acting Commissioner until Dr. Margaret Hamburg is confirmed. Numerous FDA physicians and scientists are certain that Dr. Hamburg and Dr. Sharfstein will bring the necessary change to FDA to guarantee integrity, accountability, and transparency, to ensure that all future decisions are solely based on science and in accordance with the laws, rules, and regulations. However, sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too
long.

The latest example of wrongdoing was reported on March 23, 2009 from a Federal District Court Judge who ruled that FDA’s decision on the Plan B drug1 was “arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.” FDA’s top leaders at the Center for Drug Evaluation and Research (CDER) testified that they “didn’t have a choice, and . . .
[weren’t] sure that [they] would be allowed to remain [in their positions if they] didn’t agree” to ignore the science and the law. To the contrary, they should be removed from their positions of authority precisely because they didn’t follow the science and the law. The judge further ruled that there was “unrebutted evidence that the FDA’s [decision] stemmed from political pressure rather than permissible health and safety concerns.” The “improper political influence” and the many “departures from its own policies” reveal that such FDA officials are incapable of ensuring integrity and science at FDA.

On October 14, 2008, FDA physicians and scientists wrote to members of the House Energy and Commerce Committee reporting that top FDA officials at the Center for Devices and Radiological Health (CDRH) had distorted the scientific review of medical devices and then retaliated against those who brought this to light.2 Congressman John Dingell (then Chairman) and Congressman Bart Stupak (Chairman, Subcommittee on Oversight and Investigations) wrote to then FDA Commissioner Dr. Andrew C. von Eschenbach (since resigned), stating that there were “well-documented allegations that senior managers within CDRH” had “acted in violation of the law … [and that] sweeping measures may be necessary to address the distortion of science alleged by so many CDRH scientists.”3

On January 7, 2009, FDA physicians and scientists wrote to Mr. John Podesta4: “Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around.
Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal. … America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re- establishing a proper and effectively functioning FDA is vital to the physical and economic health of
the nation.”5

On January 13, 2009, the NY Times6 reported that FDA officials allowed “improper political influence”7 to guide official FDA actions. The Director of the Office of Device Evaluation, Dr. Donna-Bea Tillman, approved8 a medical device used for the detection of breast cancer despite the fact that all of the FDA experts involved recommended against approval of the device three times. Dr. Tillman’s decision to overrule the FDA experts “followed a phone call from a Connecticut congressman [Christopher Shays].”

On January 26, 2009, FDA physicians and scientists wrote to you directly9 seeking your help and recommending that “you remove and hold accountable all managers who have ordered, participated in, fostered or tolerated the well-documented corruption, wrongdoing and retaliation at the Agency.” That letter was prompted by concerns that FDA officials were planning to investigate physicians and scientists in retaliation for the January 13, 2009 story in the NY Times. These concerns were well-
founded.

On March 13, 2009, one week after another episode detailing wrongdoing and improper political influence involving top FDA officials was published in the Wall Street Journal,10 Acting Commissioner Dr. Frank M. Torti and FDA attorneys sprung into action. Their solution— send an FDA-wide email11 admonishing FDA employees that they “must comply with … obligations to keep certain information … confidential … [including] e-mail to and from employees within FDA [that document the] deliberative process” and threatening that “violation … can result in disciplinary sanctions and/or individual criminal liability.”

These threats did not escape the scrutiny of Senator Chuck Grassley,12 Ranking Member of the U.S. Senate Committee on Finance. In a letter to Dr. Torti on March 24, 2009, Senator Grassley wrote:
“Your memorandum … appears to run contrary to many statutes protecting executive branch communications with members of Congress. … I am concerned with the timing of your memorandum, given some recent high profile matters concerning your Agency and the release of information that has shown failures in FDA’s regulatory mission. [This] could be viewed … as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower protection laws. … Whistleblowers are some of the most patriotic people I know—men and women who labor, often anonymously, to let Congress and the American people know when the Government isn’t working so we can fix it.”

The Wall Street Journal13 and FDA documents14 revealed efforts by top FDA officials (including Dr. von Eschenbach, Dr. Torti, Mr. William McConagha, and other FDA attorneys) to cover-up their attempts to improperly influence, obstruct, impede and distort the due and proper administration of the FDA scientific regulatory process involving a knee implant device. According to the Columbia
University Journalism Review,15 “the [Wall Street] Journal describes a process in this case that’s, well, corrupt. I don’t know what else you’d call it. It even has a smoking gun.”16 An advisory committee of outside experts, convened to provide advice on the safety and effectiveness of the knee implant, was misled and manipulated by Dr. Daniel Schultz (Director of CDRH) as well as top FDA attorneys. Dr. Schultz was accused of “stacking the committee to get the decision the company wanted,” and of falsely stating in an official document that the conclusions reached by the advisory committee were “clear” and “unanimous”—to the contrary, they were not. A letter17 from Senator Grassley to Dr. Torti dated March 6, 2009 indicated that Dr. Schultz and top FDA attorneys had concealed the fact that two of the authors of a major publication presented to the advisory committee in support of the knee implant device, had affiliations with the device manufacturer (“the first author of the article is [the manufacturer’s] Vice President of Scientific Affairs,” Senator Grassley noted). Dr. Jay Mabrey, Chief of orthopedic surgery at Baylor University Medical Center in Dallas and Chairman of the advisory committee, should be commended for his integrity and willingness to speak out once he became aware of what had transpired. Dr. Larry Kessler, former Director of the Office of Science and Engineering Laboratories at FDA, who had direct knowledge of the advisory committee meeting and process, characterized the process as “show[ing] the FDA at its worst.”

The culture of wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior. For example, in July 2005,18 Dr. Daniel Schultz “approved a medical device against the unanimous opinion of his scientific staff,”19 overruling “more than twenty FDA scientists, medical officers and management staff.”20 According to the New York Times21, the decision represented the first time in the agency’s history that a director “approved a device in the face of unanimous opposition from staff scientists and administrators beneath him.” As described in a Senate Finance Committee report following an investigation led by Senator Grassley,22 Dr. Schultz never revealed to the public that the FDA scientists, medical officers, and all other staff involved, completely
disagreed with his decision. The report also stated that “what remains the same in FDA’s approval of a device or a drug is the requirement that data supporting a sponsor’s application for approval be scientifically sound. Otherwise health care providers and insurers as well as patients may question the integrity and reliability of the FDA’s assessment of the safety and effectiveness of an approved product.”– We completely agree.

Amazingly, just 3 weeks ago, on March 6, 2009, it was reported by the consumer advocacy organization Public Citizen that Dr. Tillman “approved a [medical] device that has failed to demonstrate any clinical benefit” and that showed “trends toward higher risks of death.”23 According to Public Citizen: The March 6, 2009 approval by Dr. Tillman24 “bears an eerie resemblance to another device, Intergel, an anti-scarring device intended for pelvic surgeries that also demonstrated reduced scarring without clinically validated outcomes. … Less than two years after Intergel was approved [by Dr. Schultz25], the company removed the product from the market26 due to reports of post-operative pain, foreign body reactions and tissue scarring requiring repeat surgery, including three deaths among women who received it. This history should have given the FDA pause before once again approving a similar device with a questionable safety record.”27

But now, things may finally change at FDA and meeting the expectations of the public may become a reality. On March 14, 2009, an FDA-wide e-mail was sent from the Acting Secretary of HHS:
“Dr. Margaret “Peggy” Hamburg will be nominated by the President to serve as the next Commissioner and Dr. Joshua “Josh” Sharfstein will serve as the Principal Deputy Commissioner of the FDA. … The FDA is the premier agency of its kind in the world, and President Obama wants to revitalize the agency and empower it to make the best possible decisions for the American people based on the best science available. Dr. Hamburg and Dr. Sharfstein will work hard to support scientific integrity at FDA, strengthening the ability of the agency’s professionals to do their work on behalf of the American people. They are the perfect people to translate the President’s vision for the FDA into reality.”

We share your vision and we urge that you provide all necessary support to enable your new leadership to bring change to FDA without delay as part of your planned healthcare reform. As stated in a recent NY Times editorial, you must “send a clear signal to the bureaucracy that the days of neglect are over. Officials [must] make clear that the … practice of distorting science and weakening regulation to favor industry also is over.”28 – We completely agree.

FDA must carry out its work in a transparent manner based on sound science in order to improve the lives of all Americans, reduce health care costs, and expand health care access. Much work remains to be done at FDA and all pending matters need to be addressed. The wrongdoing revealed in the Wall Street Journal involves top FDA officials and requires immediate investigation. Astoundingly, since May 2008,29 Dr. von Eschenbach, Dr. Torti, Mr. McConagha, and numerous top FDA officials, have been well-aware of other serious wrongdoing, and failed to take any actions, while the physicians and scientists who spoke out and refused to comply have suffered retaliation.

The clearance/approval of medical devices that were not made in accordance with the laws, rules and regulations, need to be re-visited. Furthermore, those FDA employees who have engaged in wrongdoing, who have violated laws, rules, and regulations, who have abused their power and authority, and/or who have engaged in retaliation, should be dealt with swiftly. Immediate and decisive disciplinary action will send a strong message FDA-wide that wrongdoing will no longer be tolerated and those who engage in wrongdoing will be held accountable. Some wrongdoing may be beyond the scope of FDA’s jurisdiction and may need referral to the U.S. Attorney General.

All FDA employees who are committed to public integrity, who follow the laws, rules and regulations, who use science to promote public safety and health, and who have the courage and patriotism to speak out, must be protected and have their professional lives restored. We ask that you accept nothing less.

Sincerely,

[Names Redacted]

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