A widely prescribed drug to treat Type 2 diabetes substantially increases the risk of heart attacks and death from cardiovascular disease, according to a study released today that critics say questions the government's ability to monitor drug safety.
Patients who took Avandia to reduce their blood sugar levels were 43% more likely to have a heart attack than patients who were given other medications or a placebo.
Researchers also found that the drug boosted the chances of dying of heart disease by 64%, according to the report in the New England Journal of Medicine.
The Food and Drug Administration responded by issuing a safety alert on Avandia, recommending that diabetes patients who take the medication discuss the heart risk with their doctors.
Dr. Curt Furberg, a prominent drug safety expert at Wake Forest University who co-wrote an editorial accompanying the study, said the FDA should take Avandia off the market.
"When I look at the totality [of the findings], there's enough for me to pull it," he said.
GlaxoSmithKline, the company that makes Avandia, attacked the study as an incomplete analysis of data from disparate studies that are difficult to combine. The London-based pharmaceutical giant reported $2.8 billion in Avandia sales last year.
GlaxoSmithKline stock tumbled 7.8% after the study's release and closed at $53.18 on the New York Stock Exchange, erasing nearly $13 billion in market value.
News of the possible risks of Avandia also ignited a furor on Capitol Hill on Monday, where three major committees announced investigations. Some lawmakers and their staffs have been quietly probing the issue, and congressional investigators said the drug could be responsible for as many as 11,600 heart attacks a year.
The concerns over Avandia could have a major effect on an FDA reform bill making its way through Congress. The Senate-passed version, which the House will soon take up, has been criticized by some consumer groups and lawmakers as too accommodating to industry.
The 200-page bill would significantly boost funding for drug safety, set up a new computerized surveillance network to broadly monitor for risky side effects, and create a legal framework for dealing with drugs that could pose problems.
"This is the latest reminder that FDA isn't effectively monitoring the safety of drugs used by millions of Americans once they are on the market," said Rep. Henry A. Waxman (D-Los Angeles), who has scheduled a June 6 hearing on the matter with the Oversight and Government Reform Committee.
