New FDA Docs Link Avandia to Increased Risk of Heart Attack, Stroke, Death

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GlaxoSmithKline’s controversial diabetes drug Avandia — the most popular diabetes drug in the world — increases the risk of heart attacks, strokes, and death.

*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact)

What’s the problem?

New documents linking Avandia to an increased risk of heart attack, stroke, and even death were released last week by the FDA in advance of an unprecedented 2-day advisory panel that will determine whether the agency pulls the diabetes drug off the market. The panel of independent medical professionals will also investigate an internal battle brewing within the FDA, as some scientists have been calling on the agency to take Avandia off the market for years.

Dr. David Graham and Dr. Kate Gelperin of the FDA say that continuing a study of Avandia versus another diabetes drug, Actos, would be “unethical and exploitative.” GSK has its own studies and disagrees with Graham’s conclusions.

Avandia used to be a multibillion-dollar-a-year drug. Since its safety came under attack, sales have slumped. According to the Wall Street Journal, in the first quarter of this year, world-wide sales of Avandia were about $245 million, down 10 percent from a year earlier.

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