Tainted products marketed as dietary supplements potentially dangerous. FDA statement letter

December 23, 2010

 

December 23, 2010 – This blog post presents a letter sent out by the American Food and Drug Administration (FDA). The letter addressed the issue of undeclared drugs or drug analogues in dietary supplements mostly geared towards (sexual)  performance enhancements, weight loss products, and/or body building products. While the FDA addresses with its statement letter manufacturers, distributors and consumers in the US, the problem seems to exist worldwide, and everyone taking such products may find useful information as to her/his own safety in the statement by the FDA, which follows here below.

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The U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

“These tainted products can cause serious adverse effects, including strokes, organ failure, and death,” said FDA Commissioner Margaret A. Hamburg, M.D. “The manufacturers selling these tainted products are operating outside the law.”

The FDA is seeking input and collaboration from dietary supplement trade associations to educate the industry about this problem and to help develop new strategies to combat it, according to Hamburg. The agency also announced a new RSS feed to warn consumers more quickly about tainted products marketed as dietary supplements.

The FDA has noted the three most common categories of these illegal products:

  • Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).
  • Body-building products containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
  • Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Companies that make or distribute tainted products may receive warning letters and/or face enforcement actions such as product seizures, injunctions, and criminal prosecution. Responsible individuals may also face criminal prosecution.

Lawful dietary supplements contain minerals, vitamins or other dietary ingredients and are intended to be an addition to a standard diet. The FDA regulates these products under the Dietary Supplement Health and Education Act, passed by Congress in 1994. Unlike drugs, dietary supplements do not have to be approved by the FDA prior to marketing. Dietary supplement manufacturers and distributors are responsible for selling a safe product. FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products.

More information can be found under the following links:

Letter to Industry: http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/UCM236985.pdf

Tainted Products Marketed as Dietary Supplements: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236774.htm

RSS Feed: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml

Tainted Body Building Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234523.htm

Tainted Sexual Enhancement Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234539.htm

Tainted Weight Loss Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234592.htm

Photos of Tainted Products Marketed as Dietary Supplements: http://www.flickr.com/photos/fdaphotos/sets/72157625502079212/

Dietary Supplements: http://www.fda.gov/Food/DietarySupplements/default.htm

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Bevacizumab [Avastin]: Process for Removal of Breast Cancer Indication Begun Because of Lack of Efficacy

December 19, 2010

December 16, 2010  –  Today, the American Food and Drug Administration notified healthcare professionals and patients that it is recommending removing the breast cancer indication for Bevacizumab [Avastin] because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

Background:

The Food and Drug Administration (FDA) is making this recommendation after reviewing the results of four clinical studies of Bevacizumab [Avastin] in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. None of the studies demonstrated that patients receiving Bevacizumab [Avastin] lived longer and patients receiving Bevacizumab [Avastin] experienced a significant increase in serious side effects. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

Recommendation:

Oncologists currently treating patients with Bevacizumab [Avastin] for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

Patients currently receiving Avastin for breast cancer should speak with their oncologists about whether to continue their treatment or explore other treatment options.

More Information:

[12/16/2010 – News Release – FDA]
[12/16/2010 – Questions and Answers about Avastin – FDA]
[12/15/2010 – Avastin Decision Memo (PDF – 125KB) – FDA]

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Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury

December 13, 2010

December 13, 2010 – We learn today that the European Medicines Agency (EMEA) has been informed of Pfizer’s decision to voluntarily withdraw Sitaxentan [Thelin] from the market worldwide further to new information on two cases of fatal liver injury. Pfizer has also decided to discontinue all ongoing clinical trials.

Sitaxentan [Thelin], has been authorised in the European Union (EU) since 2006 for the treatment of pulmonary arterial hypertension (PAH). Sitaxentan [Thelin] was marketed in 16 European Union (EU) Member States, in Australia and in Canada.

Sitaxentan [Thelin] has been known to be associated with liver toxicity and since its initial marketing authorisation has been contra-indicated in patients with mild to severe hepatic impairment (Child-Pugh Class A-C) and elevated aminotransferases prior to initiation of treatment.

At this stage, patients taking Sitaxentan [Thelin] or participating in Sitaxentan [Thelin] studies are advised not to stop treatment and to consult their treating physician to review their treatment at their next scheduled appointment.

The Agency’s scientific Committee for Medicinal Products for Human Use (CHMP) will look at this issue during their plenary meeting on 13–16 December 2010 and will provide detailed advice for patients and prescribers.

There exist alternatives for the therapy of pulmonary arterial hypertension (PAH), among them, and depending on their availability in the different markets worldwide, Bosentan (Tracleer), Sildenafil [Revatio], Ambrisentan [Letairis, EU trade name Volibris], and Tadalafil [Adcirca].


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