Erectile Dysfunction Supplements Seized by U.S. Marshals
April 10, 2008
At the request of the U.S. Food and Drug Administration, today U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.
The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking.
“The FDA will not tolerate companies marketing unapproved drugs — products that have not proven to be safe or effective — as dietary supplements,” said Margaret O’K. Glavin, associate commissioner for regulatory affairs. “The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products.”
The seized products, which originated in China, are packaged and distributed by Shangai Distributors, Inc. of Coamo, Puerto Rico. Although the products’ labels state they are natural supplements, these products are drugs and their sale is illegal without FDA approval. Before a new drug product may be legally marketed, it must be shown to be safe and effective.
In response to a consumer complaint, the FDA conducted an inspection of Shangai Distributors Inc., in November 2007. The FDA’s investigation and testing revealed that the seized products contained active drug ingredients found in FDA-approved ED prescription drugs and/or a substance with a structure similar to such drugs that may cause similar side effects and drug interactions. None of the drug ingredients are listed on the labels of any of the seized products.
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.
Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company did not take any action to correct the violations. The FDA issued a press release on December 28, 2007 advising consumers not to buy or use the products. Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA’s enforcement actions.
The FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they believe are related to the use of these products.
Popularity: 81% [?]
Hazardous Levels of Selenium in “Total Body Formula” and”Total Body Mega Formula”
April 10, 2008
The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.
On March 27, the FDA warned consumers not to purchase or use “Total Body Formula” in flavors Tropical Orange and Peach Nectar and “Total Body Mega Formula” in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee . The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.
Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.
Popularity: 80% [?]
FDA to Force Medical Device Manufacturer Pay for Violating Law
March 29, 2008
The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.
The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.
The agency’s complaint, originally filed this past November and amended on March 17, seeks penalties against California medical device manufacturer Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.
The complaint alleges that Advanced Bionics shipped hearing aids to customers in the United States prior to filing appropriate supplemental information with the Agency, including a notice of changes made to the devices that affected their safety and effectiveness.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a cochlear implant hearing aid surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The hearing aid is considered a Class III device by the FDA—the most stringent regulatory category for devices.
The complaint alleges that the company failed to comply with the FDA’s current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products.
Advanced Bionic’s alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the hearing aid by testing lots under actual or simulated use when the unapproved vendor’s component was used.
The complaint also states that Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. Two hearing aids shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.
FDA’s complaint states that the company’s failure to file the required supplement occurred after a 2001 inspection. At that time, the company was cited for similar failures and made commitments to correct the problems.
Popularity: 72% [?]
Cantaloupe from Honduran Grower Tainted with Salmonella
March 24, 2008
The Food and Drug Administration (FDA) is advising consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from Agropecuaria Montelibano, a growing and packing company in Honduras. If so, consumers should throw away the cantaloupes.
Based on current information, fruit from this company appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada.
To date, FDA has received reports of 50 illnesses in 16 states and nine illnesses in Canada linked to eating cantaloupes. The states are Arizona, California, Colorado, Georgia, Illinois, Missouri, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Tennessee, Utah, Washington, and Wisconsin. No deaths have been reported; however, 14 people have been hospitalized.
Symptoms of Foodborne Salmonella Infection
Symptoms include nausea, vomiting, fever, diarrhea, and stomach cramps. In individuals with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections. Individuals who have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.
Tips for Consumers
To reduce the risk of getting Salmonella or other foodborne illnesses from cantaloupes:
Buy cantaloupes that are not bruised or damaged. If buying fresh-cut cantaloupe, be sure it is refrigerated or surrounded by ice.
After purchase, refrigerate cantaloupes promptly.
Wash hands with hot, soapy water before and after handling fresh cantaloupes.
Scrub whole cantaloupes by using a clean produce brush and cool tap water immediately before eating. Don’t use soap or detergents.
Use clean cutting surfaces and utensils when cutting cantaloupes. Wash cutting boards, countertops, dishes, and utensils with hot water and soap between the preparation of raw meat, poultry, or seafood and the preparation of cantaloupe.
If there is a bruised or damaged area on a cantaloupe, cut away that area before eating.
Throw away any leftover cut cantaloupe if it’s left at room temperature for more than two hours.
Use a cooler with ice or use ice gel packs when transporting or storing cantaloupes outdoors.
Popularity: 58% [?]
Bush’s Legacy
March 21, 2008
Stephanie Mencimer, Mother Jones
When it comes to notorious Bush political appointees, Daniel Troy’s name doesn’t usually make the top-10 list, overshadowed as he is by more high profile cronies such as FEMA’s Michael Brown. But for three years in the president’s first term, Troy served as the chief counsel to the Food and Drug Administration (FDA), where he quietly advanced a legal revolution that is playing out in earnest in the U.S. Supreme Court this year. This revolution has the potential to affect the health and safety of the nation’s citizens for years to come, all while making Troy a rich man. In fact, his career is an illustration of how the Bush administration’s revolving door has allowed industry lawyers to radically reshape regulatory agencies to benefit the big businesses they once represented and then profit from those changes when they return to the private sector.
Popularity: 55% [?]
Prescription Drug Sales Growth Slows To Lowest Rate Since 1961
March 15, 2008
Sales growth in the U.S. prescription drug market slowed to the lowest rate in 46 years in 2007 as more brand-name drugs lost their exclusivity to generics and new product approvals declined, according to a report issued Wednesday.Sales came to $286.5 billion in 2007, up 3.8 percent, IMS Health said in its annual U.S. Pharmaceutical Market Performance Review. The rate of growth was the lowest since 1961, when sales increased by 3.3 percent.
In contrast, prescription drug sales grew by 8 percent in 2006.
Growth moderated beginning in 2001, but picked up in 2006 with the start of the federally subsidized prescription drug program for seniors, Norwalk-based IMS Health said. However, growth slowed again last year.
The Medicare Part D program accounted for 19 percent of retail prescriptions at the end of last year, a modest increase over 2006 “and reflective of a maturing program,” IMS said in its report. It said 65 percent of Americans 65 and older are now enrolled in the program.
Learn More: AP/Houston Chronicle
Popularity: 52% [?]
FDA to establish offices in China
March 15, 2008
In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government.
This is an important step forward in the FDA’s plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.
“In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters,” said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. “Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market.”
Building the FDA’s capacity outside of the United States supports the agency’s “Beyond our Borders” initiative. The initiative facilitates the building of stronger cooperative relationships with the FDA’s counterpart agencies around the world and enhanced technical cooperation with foreign regulators. The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet U.S. standards for safety and manufacturing quality.
Popularity: 56% [?]
Kohl Hearing Seeks Alternative to Drug Industry’s Controversial Practice of Educating Doctors about New Drugs
March 13, 2008
Today U.S. Senate Special Committee on Aging Chairman Herb Kohl (D-WI) held a hearing to consider an alternative to the current prevailing practice of doctors receiving the latest information on new drugs from the drug manufacturers themselves. Pharmaceutical sales representatives are currently one of the only ways doctors can learn about new drugs on the market. The industry’s educational outreach is essentially a marketing program, and evidence shows that doctors’ prescribing patterns can be impacted by pharmaceutical sales representatives. Wednesday’s hearing considered the implications of creating a federal “academic detailing” program, which would provide physicians and other prescribers with an objective source of unbiased information on all prescription drugs, based on scientific research.
“Pharmaceutical reps often confuse educating with selling, and evidence shows that doctors’ prescribing patterns can be heavily influenced by these sales representatives,” said Chairman Kohl. “Without academic detailing, physicians may not have access to information about the full array of pharmaceutical options, including low-cost generic alternatives. However, research has shown that when they do, doctors prescribe the best drug—not just the newest one—and healthcare spending is lowered.”
Chairman Kohl plans to introduce a bill with Senator Dick Durbin (D-IL) this spring to create a federal academic detailing program. The proposed legislation would create a grant program to fund the production of educational materials for doctors on the safety and comparative effectiveness of prescription drugs, including generic and over-the-counter alternatives. The policy would also create a second grant program to dispatch trained medical professionals (such as pharmacists, nurses, and other health care professionals) into physicians’ offices to distribute the extensively researched and independent information. Because academic detailing lowers healthcare costs for the government, the bill is expected to pay for itself.
The hearing began with testimony from Shahram Ahari, a former sales representative for the pharmaceutical company Eli Lilly. Mr. Ahari shared with the committee his experiences as a drug detailer and discussed the techniques he employed when marketing drugs to doctors. Next, Dr. Jerry Avorn, a Professor of Medicine at Harvard Medical School and consultant to Pennsylvania’s academic detailing program, outlined the concept of academic detailing and talked about state and international programs already underway. Nora Dowd Eisenhower, Secretary of the Pennsylvania Department of Aging, offered a government perspective on the impact of academic detailing initiatives at the state level. Allan Coukell, a pharmacist and Director of the consumer group The Prescription Project in Boston, testified about the cost savings of academic detailing programs and how patients stand to benefit when doctors have access to unbiased information. Last on the panel, Ambrose Carrejo, Assistant Director of Pharmaceutical Contracting and Strategic Purchasing for the managed-care organization Kaiser Permanente, spoke to the committee about Kaiser’s twenty-year history with fact-based drug information distribution and how it has impacted both doctors and patients.
Last June, the Committee held a hearing examining the relationships between physicians and the pharmaceutical industry. Following the hearing, Chairman Kohl and Finance Committee Ranking Member Charles Grassley (R-IA) introduced the Physician Payment Sunshine Act (S.2029) to require manufacturers of pharmaceutical drugs, medical devices, and biologics to disclose the amount of money they give to doctors through payments, gifts, honoraria, travel and other means. The drug industry has challenged the Grassley-Kohl bill, claiming that the legislation will potentially restrict their ability to inform doctors about new drugs. The academic detailing legislation under consideration by Chairman Kohl and Senator Durbin addresses this charge.
Popularity: 46% [?]
Internet Drugs Falsely Claim to Prevent, Treat STDs
March 13, 2008
The Food and Drug Administration (FDA) is alerting consumers about certain drugs they may have purchased over the Internet. The products are sold as
* Tetrasil
* Genisil
* Aviralex
* OXi-MED
* Imulux
* Beta-mannan
* Micronutrient
* Qina
* SlicPlus
The products falsely claim to prevent or treat a variety of sexually transmitted diseases (STDs), including
* herpes
* chlamydia
* human papillomavirus (HPV)
* cervical dysplasia
* HIV/AIDS
Some of these products falsely claim to have “FDA Approval” and some claim to be “more effective” than conventional medicine. Examples of claims that these products make include
* “Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications”
* “Greatest STD Protection Without Condoms”
* “The active ingredient in our product is FDA certified to destroy 99.9992 percent of all pathogenic organisms [i.e.] Chlamydia”
Why Consumers Should be Concerned
“STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs,” says Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research.
If you took any of these drugs please contact me through the form below. I would like to here from you.
Popularity: 96% [?]