Class Action Blog : Consumer Fraud, Consumer Protection, Securities and Antitrust Lawyer & Attorney : Meiselman, Denlea, Packman, Carton & Eberz

Sibutramine is a controlled substance drug known as an oral anorexiant. It is a form of medication known as an appetite suppressant, which works by acting on the appetite control centers in the brain to decrease appetite. It was previously marketed and prescribed by physicians as part of the treatment for weight loss, and was used in combination with a reduced calorie diet and exercise to help people who are overweight lose weight and maintain their weight loss.

In 2008, the United States Food and Drug Administration issued an alert to consumers naming 27 different products marketed as dietary supplements for weight loss that contained illegal and undisclosed amounts of sibutramine. By 2010, the manufacturer of sibutramine had withdrawn the drug from the market altogether after study showed an increased risk of stroke and other cardiovascular problems in persons who were prescribed the medication. The manufacturer had performed a study at the request of the Food and Drug Administration, which ultimately demonstrated a 16% increase in the risk for serious cardiovascular events such as heart attack, stroke, myocardial infarction, and death. Sibutramine is not supposed to be prescribed or sold in the United States, and if “off the market.”

Unfortunately, sibutramine continues to appear on the market, mostly in products that are marketed as dietary supplements for weight loss. Just recently, on October 18, 2011, the Food and Drug Administration issued alerts to consumers advising them not to use or purchase several products that were found to contain sibutramine. The agency issued alerts advising consumers to avoid the products known as "Magic Slim,” “Advanced Slim 5” and “Magic Slim Tea” because they were all found to contain the illegal drug sibutramine.

It is illegal and extremely dangerous for manufacturers of so-called "dietary supplements" to mix sibutramine in their products, and it is unfortunate that some unscrupulous manufacturers continue to do so.  If you or someone you know has been injured by sibutramine, please contact us to discuss your legal rights.

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The Food and Drug Administration ("FDA") recently required the manufacturers of two purported "dietary supplements" to recall their products because they contained unapproved drug ingredients.  The products, Svelte 30 (manufactured by Svelte 30 Nutritional Consultants) and Extenze (manufactured by Biotab Nutraceuticals, Inc.), were found to contain sibutramine.  Although sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss, it is a controlled substance, which was withdrawn from the market in October 2010 for safety reasons.  Several lots of Extenze also were found to contain prescription drugs used to treat erectile dysfunction.

Products containing a drug ingredient must be approved by the FDA.  As a result, manufacturers sometimes seek to market their products as "dietary supplements", even tough they contain a drug ingredient, to escape the expensive and rigorous FDA approval process.  Unlike drugs, manufacturers may market dietary supplements simply upon giving the FDA notice within thirty days after they start marketing the product.  If the FDA does not formally object, the manufacturer may continue to market the product without the FDA having made any determination as to its safety or efficacy.

Because the FDA has not approved Svelte 30 and Extenze, their safety and effectiveness are unknown.  In fact, their drug ingredient, sibutramine, is known to substantially increase blood pressure or pulse rate in some people and may be especially risky for those with a history of heart problems or stroke.  Additionally, drugs like sibutramine, which are used to treat erectile dysfunction, may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

The FDA product recall includes the following:

• Svelte 30 Orange & Gray Capsules:  Svelte is marketed as a natural herb for weight loss and is packaged in plastic bottles containing 30 capsules per bottle.  The recalled products have UPC numbers from 04-3000 to 04-5999, manufacturing date of 10/22/2010, and expiration date of 10/21/2012.
• Extenze Tablets:  Two lots of counterfeit products sold nationwide are packaged as a card of four packs (lot 0709241) and a box of 30 tablets divided into two 15-tablet blister packs (lot 0509075).  It is possible that there may be other Extenze counterfeit products on the market that have not yet been identified.

If you, or someone you know, has purchased or used Svelte 30 or Extenze containing sibutramine, please contact us to discuss your legal rights.

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The ever present desire for athletes to train to the extreme to obtain an edge on the competition exists at every level of athletics from high school to the professional athlete.  In the past this desire has led to the imprudent use of anabolic steroids by athletes in all levels of competition.

The dangers of using anabolic steroids have been well-documented and the subject of extensive media coverage.  The BALCO investigation is just one example. The serious and often fatal risks associated with using steroids to increase body strength and performance, clearly should prohibit the use of such substances.  There is, however, the ongoing desire to obtain that edge on the competition.   Thus, to avoid the stigma associated with steroids, certain products have been developed by some manufacturers that have been marketed as dietary supplements, but which actually contain synthetic steroids.

The Food and Drug Administration (“FDA”) issued a Public Health Advisory on July 28, 2009, warning consumers to stop using body building products marketed as dietary supplements, but are instead unapproved and misbranded drugs.  These products are sold online and in retail stores and are promoted as hormone products and/or alternatives to anabolic steroids.  The FDA warned that these products are potentially harmful and that it has not approved them or reviewed their safety before marketing.

The FDA also sent a warning letter to American Cellular Labs, the manufacturer of TREN-Xtreme and MASS Xtreme.  Other products identified by the FDA include ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT‑40‑Xtreme.

The FDA has received adverse event reports for these products which include cases of serious liver injury, stroke, kidney failure, and pulmonary embolism.  Other conditions that can be associated with these products include shrinkage of the testes, male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse affects on blood lipid levels and increased risk of heart attack and stroke.  As such, the FDA recommends that consumers immediately stop using these products and has also cautioned that athletes taking these products may test positive for performance-enhancing drugs.

If you have been injured as a result of using any of these products, please contact us to discuss your legal options.

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