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Monday, October 11, 2010

FDA Requests "Voluntary" Withdrawal of Dangerous Drug Meridia

On Friday, the Food and Drug Administration (FDA) requested that Abbott Laboratories withdraw its diet drug Meridia (sibutramine) due to the drug's increased risk of stroke and heart attack. The action comes years after the drug's 1997 approval, which was given over the objections of the FDA's own advisory panel, which voted 5-4 that the benefits of Meridia did not outweigh the risks, and 8-0 that the drug's side effect of increasing blood pressure was "clinically important." The FDA's medical officer further commented that the drug "has an unsatisfactory risk-benefit ratio" and that it "does not improve and in some cases it aggravates major obesity-related co-morbidities."

However, the dangerous drug was approved, with restrictions, and even survived several subsequent petitions for Meridia's removal, notably in 2002-2005 by consumer advocate group Public Citizen. However, the publication of the results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial showed that sibutramine use increased the risk of:

  • All major cardiovascular problems by 16%
  • Non-fatal heart attack by 28%
  • Non-fatal stroke by 36%

In advocating for the drug's removal at the September 15 advisory committee, Public Citizen notes that since its original petition, over 3.6 million Meridia prescriptions have been written, and a conservative estimate says that nearly 3000 of them have suffered a heart attack or stroke as a result of this medication.

The SCOUT trial was the first large-scale, long-term study of a diet drug, completed 12 years after the drug's approval. As a result of the Meridia "fiasco," many people have called for large-scale, long-term trials of diet drugs to be undertaken before drug approval rather than after. Such trials should be extended to all drugs in order to prevent the approval of dangerous drugs like Accutane and Avandia, whose large-scale risks are only hinted at in pre-approval trials.

In its defense, Abbott Laboratories said that the trial misrepresented the true risk of Meridia because it focused on a contraindicated patient population (those with existing cardiovascular problems), and did not follow labeling recommendations on when to discontinue Meridia use. Abbott Laboratories maintains that the drug is safe and beneficial for the small population that experiences significant weight loss on the drug, which can typically be identified in the first three months of use.

If you have suffered a heart attack or stroke during or shortly after use of Meridia for weight loss, you may be able to receive compensation for your injuries. The Cochran Firm is prepared to fight for your rights. To learn whether we can help you, please contact the personal injury lawyers of The Cochran Firm for a free case evaluation.

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posted by Benjamin A. Irwin at 9:56 AM

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