September 24, 2010

FDA Restricts Avandia in U.S.

In response to controversial safety data suggesting that Avandia increases the risk of heart attack and strokes in diabetics, the FDA announced on September 23, 2010, that Avandia will now only be available under a restricted access program to patients whose Type-2 blood sugar cannot be controlled with rival medications in the same drug class.  Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.  According to the FDA, doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the restricted access program will limit use of Avandia significantly.  Also, GlaxoSmithKline has been ordered to convene an independent group of scientists to review key findings of questionable RECORD clinical trial data and clarify the reliability of the findings.  The RECORD clinical trial study by GSK compared Avandia’s cardiovascular risks to other diabetes drugs.

Meanwhile, on the same day, the European Medicines Agency (EMA) took the opposite approach and recommended that sales of Avandia be suspended in that country.   Avandia will continue to be available for what the European Medicines Agency characterized only as a period of "months." A recent article in the British Medical Journal argued that Avandia should have never been placed on the market in the U.K.

In July of 2010, an FDA panel gave a split decision on Avandia with 20 of 33 panelists voting to keep the controversial drug on the market with more restrictions.

Click here to learn more about the new restrictions

Click here to read more about litigation involving Avandia

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