Heart attack risk in diabetes drug shows FDA faults


Monday, May 21, 2007

Heart Attack Risk in Diabetes Drug on Market for 8 Years Underscores Urgent Need for Drug Safety Reform in Congress

Consumers Union urges the House to pass strong drug safety reforms now

(Washington, D.C.) – A new analysis that the top-selling oral diabetes drug Avandia – which has been on the market for eight years – may significantly increase the risk of heart attack in patients again underscores the urgent need for Congress to pass strong drug-safety reform legislation this year, Consumers Union said.
Consumers Union said today’s New England Journal of Medicine analysis is yet another example of the FDA’s lax post-market safety oversight system, and vividly illustrates the need for Congress to pass reforms to more quickly detect – and act on – safety problems with drugs already on the market.
The NEJM study analyzed 42 existing trials of patients taking Avandia compared to other drugs or a placebo, and found that those taking Avandia were 43 percent more likely to have a heart attack. It also suggested a trend toward higher death rates in the Avandia group.
CU also said the Avandia case also raises questions about how much information the FDA had about the increased risk of heart attack in patients, and when the agency knew of those potential risks and when it would communicate them to the public. In issuing a safety alert today on the drug after the NEJM analysis was released, the FDA said that GlaxoSmithKline, the manufacturer of Avandia, had “recently provided FDA with a pooled analysis of 42 randomized clinical trials” that showed a 30-40 percent greater risk of heart attack.
CU supports legislation to dramatically improve the FDA’s post-market safety system and authority, and to require all clinical drug trial results be made public so doctors, researchers and patients can more quickly know about a drug’s possible risks.
The Senate recently passed major drug safety reform legislation, but it gives the FDA 2 ½ years to develop guidelines for making some, but not all, clinical trial results public. Stronger legislation has been introduced in the House (HR 1561) that would among other things make more clinical trial data available to the public more quickly, but it has yet to be acted on.
Contact: Susan Herold, CU, (202) 462-6262
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