FDA Questions Safety of Avandia

LLFClerk LLFClerk

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Patients need to be informed, ask questions and protect themselves.

Avandia (rosiglitazone) is a drug used by patients with type 2 diabetes. The FDA has recently discovered that patients taking Avandia show an increased risk of heart attack and other heart-related deaths. The FDA has not yet issued a recall, however, since they are continuing to conduct tests on the safety of this drug.

The FDA continues to supply the drug's sponsor, GlaxoSmithKline, with the safety information they have been gathering, but do not have conclusive evidence to stop production of the drug. The FDA wants the patients taking Avandia to be aware of the potential risks so that they can talk with their doctors and make an informed decision for their individual health needs. The FDA is being cautious in their actions since it is a risk for diabetes patients to switch medications at anytime and so taking a patient off Avandia may not be the best solution if it is not necessary.

The FDA has been monitoring Avandia since its approval in 1999 and has been conducting trials to test for heart-related problems associated with this drug. A recent study produced the following data:

Patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.