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Steven J. Klearman
Steven J. Klearman
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Avandia Controversy: Senate Report Says Drugmaker Had Duty to Warn of Heart Risks

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Avandia, a drug produced by GlaxoSmithKline (GSK) and used to control Diabetes, was the subject of a Senate report released Saturday.

Among the report’s finding was that "The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public."

The report concluded that "GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner."

The report concluded that GSK failed to do so: "GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug
ACTOS (pioglitazone) might reduce cardiovascular risk."

According to the Associated Press, the FDA had "ordered a warning to be included on Avandia’s label in 2007, saying that it might increase the risk of heart attacks, though the data on those risk was inconclusive."

The Senate Report asks the FDA "why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007."

The FDA has issued a statement that review of Avandia is "ongoing," but has offered the following advice for patients who take rosiglitazone (Avandia):

  • Don’t stop taking your medication without talking with your health care professional.
  • Discuss any questions or concerns you have about rosiglitazone with your health care professional.
  • Read the Medication Guide that comes with each rosiglitazone prescription to better understand the risks and benefits of your medication.
  • Report any side effects with rosiglitazone to FDA’s MedWatch program either online, by regular mail, by fax, or by phone.