Avandia® Labeling Update: Risk of Cardiovascular Events

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Breaking News: FDA notifies 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.

Avandia (rosiglitazone): REMS – Risk of Cardiovascular Events

February 4, 2011 – As part of new restrictions for prescribing the diabetes drug Avandia, this week the FDA announced that new information has been added to Avandia’s physician labeling and patient Medication Guide. In addition to describing the cardiovascular risks – which include heart attack – 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).

Avandia was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years as concerns grew about the increased risk of heart attacks and other serious side effects from Avandia. GlaxoSmithKline (GSK) faced about 13,000 Avandia lawsuits filed by plaintiffs who accuse the company of failing to warn patients of the drug’s heart attack risks. In August 2010, the company announced it had reached settlements in about 10,000 of those suits.

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