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Senior Citizen Health & Medicine
Finding Avandia Heart Risk Underscores Need for
Urgent Drug Safety Reform
Consumers Union urges House pass strong drug safety
reforms
May 23, 2007 - 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 the recent 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 1/2 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.
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