Pfizer Inc., the world’s largest drug maker, has recalled about 1 million packets of Lo/Ovral-28 and its generic equivalent, but the company estimates that only about 30 packets were flawed. The pills were made and shipped last year.

Luckily, this particular birth control is not a very popular one.  The brand Lo/Ovral ranked 64th in U.S. birth control sales last year. The generic version, called norgestrel and ethinyl estradiol, ranked 30th, according to data firm IMS Health.

Each packet contains 28 days’ worth of the prescription, with 21 pills containing the active ingredient that prevents pregnancy and seven placebo pills. The pills are normally color-coded to note the difference.

Women are supposed to take the pills in order and not mix the placebos with the active pills. Doctors say taking three placebos or more in a row negates the pregnancy protection.

“Women who are potentially on this particular product need to be aware of (the recall) and take this quite seriously,” said Dr. Steven R. Goldstein, a New York University professor of obstetrics and gynecology.

“Patients are pretty savvy,” said Dr. Adam R. Jacobs, division director of family planning at Mount Sinai Medical Center. He said most women taking the pill would notice that the colors are out of order.

Company spokeswoman Kristen Neese said the drug maker learned about the problem when a customer called late last year to report finding a pink placebo tablet in the middle of her white birth control pills. The company found a manufacturing problem and fixed it immediately.

It issued a nationwide recall in late December asking pharmacies to pull the affected lots from their shelves. It then announced the recall Tuesday to consumers and the media after the Food and Drug Administration requested that.

Pfizer did not announce the recall publicly in December due to the relatively small size of the problem and the low risk to patient safety, Neese said.

The recall includes 14 lots of Lo/Ovral-28 tablets and 14 lots of the generic version. Both products are manufactured by Pfizer and sold in the U.S. by Akrimax Rx Products.

Pfizer said the packets are pink with the drug’s brand name or generic name on it, along with the Akrimax name. Pfizer’s logo does not appear on it.

Patients who received a packet from one of the affected lots should call their doctors immediately, Jacobs said. If they have had unprotected sex in the past five days while on one of those pill packets, they may want to consider emergency contraception.

The affected packets have expiration dates ranging between July 31, 2013, and March 31, 2014. Lot numbers are available here.

This actually happens to be the second birth control recall in the last 6 months.  In September 2011, Qualitest Pharmaceuticals issued a voluntary recall for multiple lots of their oral contraceptive, at the retail level, due to a packaging error as well.

The drugs, called proton pump inhibitors (PPI’s) are used by millions around the world who suffer from chronic and painful symptoms of indigestion.  They are a class of prescription and over-the-counter drugs that include Nexium, Dexilant, Prilosec, Prilosec OTC, Zegerid, Zegerid OTC, Prevacid, Prevacid 24-Hr, Protonix, Aciphex, and Vimovo. They are approved to treat gastroesophageal reflux disease (GERD), sometimes referred to as acid reflux, as well as gastric ulcers, erosive esophagitis and stomach bleeding associated with using non-steroidal anti-inflammatory drugs.

Researchers studied 80,000 women participating in the Nurses Health Study, a large ongoing study that began in 1976. Post-menopausal women who used PPI’s regularly for at least two years were 35% more likely to suffer hip fractures. The risk grew to 50% if the women were current of former smokers.

The numbers sound alarming, but the actual “risk” of a hip fracture is still relatively small. Among the women who used PPI’s, about two in every 1,000 fractured a hip each year. For non-users, the figure was about 1.5 fractures for every 1,000 women.

Researchers also found that two years after women stopped taking PPI’s, their risk of hip fracture returned to the level of women who had never taken them. Women taking H2 blockers to treat indigestion had a “modest” increase in hip fractures, but the risk was higher in women who took PPI’s.

PPI use increased dramatically in the U.S. when the Food and Drug Administration approved the drugs for over the counter sale in 2009. PPI’s inhibit the stomach’s production of gastric acids that can cause heartburn, acid reflux and peptic ulcers. The most widely used PPI’s are omeprazole and lansoprazole. Novartis sells lansoprazole under the brand name Prevacid.

Short term use of PPI’s is generally well tolerated, but concern has grown over their association with bone fractures, especially of the hip. PPI’s may inhibit calcium absorption, which is important for building strong bones.

Researchers say their findings are “compelling evidence” of a risk between PPI use and hip fractures. They say long term use of PPI’s should be carefully evaluated, particularly among women who have smoked or are still smokers.

“Although PPI use might be strongly indicated in some patients, at least for short-term use, we believe that clinicians should continue to carefully monitor the need for long-term use of these medications, specifically among postmenopausal women with a history of smoking,” said lead researcher Dr. Hamed Khalili, a clinical and research fellow in gastroenterology at Massachusetts General Hospital in Boston.

“Our data supports the recent decision by the U.S. Food and Drug Administration to revise labeling of PPIs to incorporate concerns about a possible increase in risk of fractures with these drugs,” he said.

It’s not known for certain why PPIs might be associated with an increased risk of fractures. But it is believed that the drugs interfere with the body’s absorption of calcium, which would lead to weaker bones.

The study was published online in the British Medical Journal.

However, a non-profit group believes that the antiepileptic drugs do carry a great risk, and are even asking federal regulators to reclassify 2 of the drugs to indicate their risk of birth defects if they’re taken by pregnant women.

According to a statement from AdverseEvents Inc., the epilepsy drugs Keppra and Lamictal should be classified as Category D because they have evidence pregnant women taking them can injure their fetus. These drugs are currently classified by the Food and Drug Administration as Class C, meaning they pose no known risk of adverse events.

The FDA provides a classification system which prescribing physicians rely on almost exclusively for determining the safety of prescription drugs for pregnant women. They are classified either B, C, D, or X. Category X drugs are those which should be avoided entirely.

Based on its study of records from Jan. 1, 2004, through March 31, 2011, held by the FDA Adverse Events Reporting Systems (AERS), AdverseEvents Inc. believes the drugs Keppra and Lamictal pose as great a risk to the fetus as drugs currently in Category D. Further, it found the top drugs listed in Category C carried a similar risk of birth defects when taken by epileptic women expecting a baby as drugs in Category D.

The study found that Keppra and Lamictal carry serious risks of birth defects and stillbirths among pregnant women taking these anti-seizure medications. Most troubling is that epileptic women typically aren’t afforded the option of stopping their anti-seizure medications due to the complications that could cause themselves and the child they’re carrying through a full pregnancy.

The release indicates: “Analysis using the RxFilter process, however, indicated that certain category C class drugs may actually be as dangerous to a fetus as drugs currently listed in category D. These results indicate that regulatory bodies may want to consider category shifts for some of the most widely used antiepilepsy medications.”

AdverseEvents Inc. urges the FDA to examine its data and compare it to the data it uses to categorize the drugs it has listed in its Category C.

The concerns raised by this study echo those found at the conclusion of other recent safety studies on the impact of epilepsy drugs to pregnant women and is the latest to indicate these drugs like Keppra may result in birth defects to fetuses.

One study found that pregnant women taking anti-seizure medications through their pregnancy faced a six percent risk of having a child born with at least one birth defect. The normal rate of birth defects among women not taking the drugs is two-tenths percent.  Taking more than one anti-seizure medication increases the risk of birth defects to close to seven percent.

Everyday Health explained that Vassiliki Cartsos, associate professor and director of graduate orthodontics at Tufts University School of Dental Medicine in Boston, and colleagues, reviewed five years of adverse events compiled by the U.S. Food and Drug Administration (FDA).

Known as antiretrovirals, these drugs may increase birth defects such as cleft lip and cleft palate, the study has found, wrote Everyday Health. At the same time, these drugs do reduce risks for mother-fetus transmission of HIV from 15-25 percent to under 1 percent. Regardless, the drugs remain unsafe during pregnancy, said the study authors, and remain under investigation.

The team discovered that seven antiretrovirals were linked to 26 incidents of cleft lip and cleft palate, but note that this association is not necessarily proof of a cause-and-effect relationship, said Everyday Health.

The drugs included in this study were: Epivir (lamivudine); Sustiva (efavirenz); Viracept (nelfinavir); and Trizivir, (abacavir sulfate, lamivudine, and zidovudine).

The study authors concluded Sustiva showed the strongest medication link to cleft lip and palate, followed by Epivir, Viracept, and Viramune. Among combination therapies, Trizivir had the strongest link, followed by Kaletra and Combivir.

According to the researchers, the findings are a red flag but do not confirm that the drugs cause birth defects.  They concluded in a journal news release that more research is needed to determine if there is a link between antiretroviral drugs and cleft lip and palate, a congenital malformation believed to have several causes, including genetic and environmental factors.

The study findings appear in this month’s issue of the journal Cleft Palate—Craniofacial Journal.

According to an L.A. Times report this week, California’s Dept. of Insurance has launched an investigation into the business practices of surgery centers in the state participating in the 1-800-GET-THIN campaign for Lap-Band gastric band surgery, insurer Aetna Inc. announced it was cooperating with the investigation.

The Dept. of Insurance has the power to file criminal charges and make arrests if they are found to have defrauded people who took part of the Lap-Band promotion as a means of losing massive amounts of weight.

In California, billboards and an intense marketing campaign promote Lap-Band devices through specialized surgery centers under the 1-800-GET-THIN promotion. It has been alleged that people who are hooked by the toll-free telephone number to at least look into the gastric band surgery are not made aware of the risks of the device.

Five people are reported to have died after having the Lap-Band device implanted at a surgery center that advertised through 1-800-GET-THIN promotion, according to public records obtained by the L.A. Times. These deaths have all happened since 2009. These surgery centers are currently facing lawsuits from patients who’ve allegedly either died or been seriously injured by the procedure to implant to the device.

The Lap-Band is a silicone ring that works by pinching the size of the stomach, thus making a person feel less hungry and suppressing the appetites of overweight people.

The Dept. of Insurance is interested in alleged fraud surrounding the surgery centers.

Lap-Band surgeries typically cost $12,000 to $20,000.  However, a recent lawsuit said the surgery centers have inflated costs and billed insurers many times that amount. In one instance, the lawsuit said, a patient was charged $179,000.

According to a report from KPCC, the Insurance Department has confirmed the probe.  “I can now confirm that the DOI has initiated an investigation into the surgery centers of 1-800-GET-THIN ,” said Dave Althausen, deputy press secretary with the California Department of Insurance.

Although, an attorney representing the surgery centers says he has not been formally notified of any insurance investigation.  He added that no evidence of wrongdoing has ever been found at the facilities.

If the purported investigation reveals criminal wrongdoing, either through insurance fraud or malpractice (i.e. not warning of the dangers of the procedure), the commission can urge local prosecutors to file charges against the individual surgery centers, doctors who provided the service and the marketing firm behind the 1-800-GET-THIN promotion.

The firm is operated out of Beverly Hills, Calif., and many of the affiliated surgery centers which participate in the promotion are also located in Southern California.

In December, the Food and Drug Administration (FDA) issued a warning against the 1-800-GET-THIN promotion, indicating advertisements to have the Lap-Band device implanted were misleading and did not provide prospective recipients with the warnings necessary to make an informed decision about the safety of the device and surgery.

Risperdal is a newer atypical antipsychotic drug. It is manufactured by Jannsen Pharmaceuticals, a division of Johnson & Johnson. Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain and headaches.

Risperdal was originally approved by the Food & Drug Administration (FDA) in 1993 to treat schizophrenia in adults. Later, its approved uses were expanded to include bipolar disorder I in adults, as well as irritability associated with autistic disorders in children from 5 to 16 years of age. Then in August 2007, Risperdal was approved for treatment of schizophrenia in adolescents aged from 13 to 17, as well as the short term treatment of manic or mixed episodes of bipolar I disorder in children aged between 10 and 17. It is not approved as a treatment for Attention Deficit Disorder (ADHD) though it is often prescribed off-label to treat children with the condition.

The study Entitled TEAM (Treatment of Early Age Mania), compared the efficacy of Risperdal with that of Depakote and lithium in children diagnosed with DSM-IV bipolar I disorder (manic or mixed phase). Between 2003 and 2008, 290 children, ages 6 to15 years at five U.S. sites were treated over 8-week periods with either Risperdal, lithium or Depakote. The patients were started on low doses of the drugs, with doses increased on a weekly basis if the child had minimal-to-no response, and no dose-limiting adverse effects.

Of the three drugs, Risperdal was found to be significantly superior for acute treatment of pediatric mania. After eight weeks, 68.5 percent of the children taking Risperdal showed improvement in manic symptoms, compared to 35.6 percent of those taking lithium and 24 percent of those taking Depakote.

The study also found that children responded well at relatively low doses of Risperdal, meaning clinicians can be conservative with the medication. The study authors also noted that lithium had significantly higher discontinuation rates than Risperdal, because Risperal was better tolerated by patients.

However, among the Risperdal group, the researchers saw significantly higher rates of weight gain, BMI increase, and presence of hyperprolactinemia. Children on Risperdal gained an average of more than 7 lbs compared to around 3 lbs for those taking lithium and 3.7 lbs for those taking Depakote. Those taking Risperdal were also more likely to experience other metabollic side effects, such as an increase in cholesterol levels, compared to those on the other medications.

The study was published online January 2 in the Archives of General Psychiatry, and was conducted by Barbara Geller, MD, Department of Psychiatry, Washington University, St Louis, Missouri, and colleagues.

Each year, Americans spend more than $28 billion on supplements assuming that they are both safe and effective. More than 100 million Americans consume vitamins, minerals, herbal ingredients, amino acids, and other naturally occurring products in the form of dietary supplements. By law, dietary supplements with established ingredients — ingredients that were sold in the United States before 1994 — may be marketed without any evidence of efficacy or safety.

But to expand its current $28-billion-a-year market, the dietary supplements industry is widely devising and selling formulations that use “novel” products — minerals, plants, or amino acids that appear newly promising, which have not circulated widely in the United States before, or which are offered in “mega-doses” much higher than have been customarily used in supplements.

Therefore, unfortunately the law that was trying to prohibit this type of thing happening, has not been enforced, and things have gotten out of control.  An industry that once produced and marketed a mere 4,000 distinct products in 1994, when the regulatory framework for dietary supplements was written into law, now markets about 55,000 products to Americans who believe them to be safe to take.

To rectify the situation, last July the FDA proposed new guidance designed to help it assess the new ingredients.

The proposed guidance clarifies the level of evidence the FDA would use to assess safety. Specifically, the safety of supplements would be evaluated according to three key factors: Documented history of use (e.g., in foods or in supplements or herbal medicines sold outside the United States), formulation and proposed daily dose (e.g., more or less than was formerly consumed), and the recommended duration of use (e.g., intermittent or long-term).

But, as stated, the industry is upset at the new guidelines.  But, why wouldn’t they be?  They have been getting away with breaking the law and making millions off of it.  Bottom line is, these new guidelines will potentially hurt their bottom line.  And, that’s why they are upset.

However, according to a New England Journal of Medicine “Perspective” article published this week by Dr. Pieter Cohen, assistant professor of Medicine at Harvard University, even the current, ambiguous criterion has received lax FDA enforcement and has probably been ignored by industry.

Dr. Cohen feels the guidelines are insufficient. For instance, “historical use” of a product is too low to ensure safety, he said, wrote the LA Times. Also, noted Dr. Cohen, there is no mandate that supplement makers provide unfavorable safety data to the FDA as long as they provide studies showing the product is safe. As for products with no history of common use or marketed at mega doses, “not even single-dose tolerability studies in humans would be required” under the proposed rules, said Dr. Cohen who pointed out that “If the FDA succumbs to industry pressure, the public health consequences will be significant,” wrote the LA Times.

But according to reports Doctors are still injecting the steroid in a way the company warns they shouldn’t, following reports that patients have died or become paralyzed after receiving steroidal shots.

The company will not go so far as to say Kenalog was responsible for those deaths or injuries and the Food and Drug Administration failed to issue its own alert, as it usually does, when Bristol-Myers Squibb changed the labels on Kenalog.

Used for neck and back pain, Kenalog and the Pfizer Inc. (PFE) drug Depo-Medrol are the most frequently administered steroids in epidural injections. Over eight million such shots were given in the U.S. in 2010.

Bloomberg reports that experts believe this warning from the drug company has largely gone ignored or unnoticed.

Physicians are either ignoring the Bristol-Myers warning or aren’t aware of it, according to doctors who use Kenalog or who work with others who do. “It is still being given in abundance,” said Christopher Gharibo, head of pain medicine in the anesthesiology department at NYU-Hospital for Joint Diseases in New York.

Neither Bristol-Myers nor the U.S. Food and Drug Administration publicized the label revision, even though the FDA is reviewing the safety of epidural steroid shots. While not required to alert doctors or patients, the FDA has broadcast changes to other drugs’ prescribing information. In June, around the time the Kenalog label was rewritten, it issued a press release about a muscle injury risks warning that Merck & Co. applied to its Zocor cholesterol pill.

The FDA defended its actions on Kenalog to Bloomberg, saying that a press release on the potential dangers of the injection was emailed to about 200,000 who receive regular updates from the agency. Whether there are actual prescribing physicians receiving those updates is unknown and based on the increased use of Kenalog, especially use that seems to ignore warning about its specific use in epidural injections.

Use of Kenalog is on the rise and as many as 8 million injections of the steroid were administered in 2010, presumably many of them as epidural treatments.

Bloomberg presumes use of Kenalog as an epidural steroid injection continues to rise because it is covered by most major insurers, so doctors who use it are guaranteed to be reimbursed for its use.

Kenalog has been implicated in at least 88 adverse reaction reports of serious injuries after its use as an epidural injection to the back or neck. At least 13 deaths have been reported among people who received any epidural steroid injection to the back or neck since 2008 when that injection, and some of those include the use of Kenalog.

The agency’s draft guidance says all unsolicited information requests be handled in a nonpublic format. The AMA noted that requests include doctor requests for details on the off-label uses of certain medications.

One of the rules encourages all responses to unsolicited requests for information be made in a nonpublic format. That includes requests from physicians for information on off-label uses for certain drugs.

The FDA is also requesting that companies respond to public requests sent Facebook or Twitter, by guided to the appropriate personnel or department for private, one-on-one help. Private responses should be science-based and answer only the question asked, said the AMA.

The new guidance does not affect information or requests received in answer to industry solicitation and do not affect social media sites maintained by physicians or health care organizations, said the AMA. The AMA and some other physician organizations have issued their own guidance to members that includes advising members to proceed cautiously and maintain patient privacy laws when communicating online with patients, said the AMA.

Most importantly, pharmaceutical companies want to know if they are liable for information posted by third parties on social media sites owned and operated by the pharmaceutical companies. How to handle information that could be viewed as reporting an adverse drug event is especially troublesome to the companies.

Industry continues to await a more complete guidance covering all of the aspects of social media with which drug companies say they need the most help. Meanwhile, Kate Conners, spokeswoman for Pharmaceutical Research & Manufacturers of America, said her firm is planning on submitting comments on the proposed guidance. “We continue to wait eagerly for adequate FDA guidance on this issue,” she told the AMA.

According to Ad Age, the “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” which was published in the Federal Register, was quietly posted after a two-year wait.

“What everybody was expecting was actual guidelines around social media,” said Jim Dayton, senior director of emerging media for InTouch Solutions, a pharmaceutically focused digital-marketing agency. “I still think it’s monumental,” he added. “The FDA finally addressed the digital channel in a specific way by mentioning Twitter and YouTube in the document, and those have never been mentioned before. But this is an industry that wants specific instructions and rules, and that didn’t happen here,” he added, wrote Ad Age.

“We understand the level of interest and wanted to get out what we had available to provide guidance,” said FDA spokeswoman Karen Mahoney. Mahoney noted that that this release was just “the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that FDA held in November 2009,” according to Ad Age.

When Facebook ceased allowing drug firms to cut off public comments on their public comment pages in August 2011, many pharmaceutical companies opted to shut down their Facebook pages, specifically pages created for specific medications, explained the AMA. According to the firms, they did not receive sufficient FDA guidance on how to handle social media comments; most said they will keep the pages down until such time as the FDA provides adequate guidance on how to handle comments, said the AMA.

The FDA is accepting public comments on the guidance through March 26.

The class-action settlement, tentatively approved on Tuesday, January 24, 2012, by U.S. District Judge Paul Crotty in Manhattan, covers more than 7,000 current and former sales representatives, according to a statement by the company and lawyers for the workers.

“We believe this settlement is in the best interest of our employees and the company,” Andre Wyss, president of Novartis Pharmaceuticals Corp., said in the statement. “We have been litigating this case for nearly six years and the company has determined that it is time to resolve these wage and hours claims.”

Novartis, the No. 2 Swiss drug maker, is “confident that sales representatives should continue to be exempt from overtime,” Wyss said.

The settlement resolves unpaid overtime lawsuits brought by Novartis drug reps in 2006, as well as some filed more recently, Bloomberg said. According to a Reuters report, the sales reps worked for Novartis between 2002 and 2007, and from Jan. 25, 2009, to the present. Payouts will vary based on length of employment and compensation, and on how many plaintiffs choose to take part in the settlement. The agreement is subject to final court approval, with a fairness hearing scheduled for May 31.

In the original class action lawsuit, Novartis sales reps maintained they did not qualify as “outside sales” employees, and thus aren’t exempt from overtime pay under the Fair Labor Standards Act (FLSA). The lawsuit was just one of many overtime claims filed against drug makers in recent years. It has long been standard practice for drug makers to avoid paying overtime for pharmaceutical sales representatives by classifying them as commissioned outside sales people, or administrative personnel, both categories that are exempt from FLSA overtime requirements.

A New York district judge had originally agreed with Novartis’ contention that the sales representatives fell under overtime exceptions to the FLSA for outside salespeople and administrative workers. But in July 2010, the Second Circuit Court of Appeals overturned that ruling. Last year, the U.S. Supreme Court refused to hear Novartis’ appeal of the Second Circuit ruling, and the lawsuit was allowed to proceed.

This settlement comes just before the U.S. Supreme Court decides in April whether drugmakers must pay overtime to as many as 90,000 sales representatives. The high court will review a lower court’s conclusion that salespeople for a GlaxoSmithKline Plc (GSK) unit aren’t covered by a federal wage-and-hour law. Similar cases are pending against Johnson & Johnson (JNJ), Bristol-Myers Squibb Co. (BMY) and a unit of Merck & Co. Arguments haven’t been scheduled.

Morningstar analyst Damien Conover, who covers the pharmaceutical industry, said he thinks the Supreme Court will likely decide that sales representatives are exempt from overtime. If it doesn’t, any fees the industry has to pay to make up for past overtime will likely amount to just a small percentage of earnings.

This news of this Novartis settlement comes just after the company announced 2000 job cuts in the United States, and experienced a major recall due to a plant mix up.