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New Warning Label for Avandia Recommended by FDA

FDA Panel Recommends Warning Label for Avandia®

WASHINGTON, DC -- August 3, 2007 -- A strong warning about heart attack risk should be added to the prescribing instructions for the diabetes drug Avandia® (rosiglitazone), according to an advisory panel to the Food and Drug Administration (FDA). Although the vote was 20 to 3 in favor of adding this alert, the panel did not recommend recalling Avandia®.

The panel's debate about Avandia® was intense. Dr. David Graham, an FDA safety officer, said that the drug had caused 205,000 heart attacks within a seven year period and should be withdrawn (NY Times, July 30, 2007). He also noted that 70% of diabetes patients die of heart disease so that a diabetes drug that raises heart attack risk is "unacceptable" (Chicago Tribune, July 30, 2007). Not surprisingly, the vice president of GlaxoSmithKline, the company that manufactures Avandia®, disagreed and said that the drug was as safe as other diabetes medications.

Dr. Sidney Wolfe of the consumer group, Public Citizen, testified about Avandia's ability to cause heart and liver problems as well as anemia. "There is no evidence of any uniquely beneficial clinical outcome for Avandia® and growing evidence of unique risks in multiple organ systems," he said (Testimony before the FDA Advisory Committee, HRG Publication #1820). "If Avandia® were up for approval today, based on what is now known, it would be summarily rejected. There should not be a double standard for removing it from the market."

Recent Avandia® Study Points to Heart Attack Risk

The advisory committee was meeting in response to a report from the Cleveland Clinic in May of this year, which found that Avandia® increased the risk of heart attacks by about 43 percent (N Engl J Med. 2007 May 21). This analysis of 42 studies also found that more Avandia® users died from heart-related problems than did patients who used other diabetes medications. Although the FDA issued an alert about Avandia®'s safety soon after the report was published, some consumer groups said this was not enough to properly warn doctors and patients (FDA Alert, May 21, 2007).

What is Next for Avandia®?

The FDA will most likely allow Avandia® to remain on pharmacy shelves at this time since it usually follows the recommendations of its advisory panel. If the agency takes the panel's advice about adding a warning to Avandia®'s prescribing instructions, it must decide on the format of that warning. Several panel members suggested adding a "black box" warning, which is a boxed alert printed in bold letters. Such a warning is the highest alert level short of recalling a drug.

Your Avandia Case

Brayton Purcell is concerned about the safety of Avandia® and the FDA panel's recommendation to let this risky medication remain on the market. The law firm is reviewing cases of patients who have taken Avandia® and suffered heart attacks. If you have been injured by Avandia®, please feel free to contact us for more information.

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