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Abandoned, but not Buried: Meridia and Sibutramine

Unlike many other dangerous prescription weight loss products, Meridia and its active ingredient were never officially banned by the FDA. The compound was saved from this fate by its manufacturers, including Abbott Labs. The makers of Meridia withdrew their sibutramine product from the market just ahead of impending FDA action.

At the time of Meridia’s withdrawal, an FDA director stated “There was no identifiable population of patients for whom the benefits of Meridia outweighed its risks.” Officially, sibutramine is no longer available in the United States.

However, sibutramine keeps showing up in the U.S. market. In numerous independent laboratory analyses, LabDoor has found heavy sibutramine contamination in imported weight loss pills and ‘all-natural’ herbal supplements. Supplements purchased from international sources via online pharmacies are a particularly dangerous source of hidden sibutramine, often escaping the relatively lax dietary supplement restrictions of the FDA.

See: Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products

Why do these major market failures keep happening?

With rising obesity levels and a huge demand for quick weight loss solutions, pharmaceutical manufacturers keep pushing new drug compounds through clinical trials. Prescription drugs must pass pre-clinical trials and three phases of clinical trials before receiving FDA approval. However, even after a new drug is approved for the U.S. market, clinical trials continue into Phase 4, where long-term studies search for side effects caused by extended use. These post-marketing clinical trials have led to the death of prescription diet pills like Meridia, but not before the products cause serious harm.

LabDoor believes that consumer product safety is too important to leave up to the manufacturers, so we lead the analysis of thousands of compounds and products using independent labs. LabDoor answers the most important questions about each product: Does it work? Is it safe? What’s the cost?

Sources

  1. Header Image: Ajay Suresh (Flickr)
  2. Abbott Labs Withdraws Meridia From the Market - New York Times
  3. Glossary of Clinical Trials Terms - ClinicalTrials.gov
     

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