FDA Knew About Avandia Heart Risks

May 2007

The Food and Drug Administration (FDA) may have released a safety alert on May 21, 2007 for Avandia – but that’s not the first time the agency has been concerned about this dangerous diabetes drug. As far back as 2002, the FDA has known that Avandia may cause heart attacks and death in patients, including many with no previous history of heart failure.

According to an internal government memo from July 16, 2002, the FDA safety office analyzed data related to Avandia’s serious heart risks. The memo covered 25 cases of people who suffered from heart-related problems while taking Avandia. Many had no prior history of heart failure.

In the memo, the FDA concluded that the evidence from these cases suggests a strong connection between Avandia and congestive heart failure in diabetes patients. A resulting recommendation to place a black box label – the government’s strongest possible warning – on the diabetes drug was rejected.

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Source: "Concerns about diabetes drug Avandia aren't new." By Ricardo Alonso-Zaldivar. Los Angeles Times. May 23, 2007.