Diabetes drug risk spurs alert

Diabetes drug risk spurs alert
By Karen Kaplan and Ricardo Alonso-Zaldivar
Copyright © 2007, Chicago Tribune
Published May 22, 2007


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 Monday that critics say questions the government's ability to monitor drug safety.

Patients who took Avandia to reduce their blood sugar levels were 43 percent 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 percent, according to the report in the New England Journal of Medicine.

The Food and Drug Administration responded by issuing a safety alert on Avandia.

But 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.

News of the possible risks of Avandia also ignited a furor on Capitol Hill on Monday, where three major committees announced investigations.

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.

"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 Waxman (D-Calif.), who has scheduled a June 6 hearing a the Oversight and Government Reform Committeet on the matter.

Lawmakers compared Avandia to Vioxx, the Merck painkiller whose 2004 withdrawal due to heart risks led to widespread consumer concerns about prescription drug safety and called into question the competence of the FDA.

Type 2 diabetes is a poorly understood disease in which patients lose the ability to metabolize sugar with insulin, leaving them vulnerable to complications such as cardiovascular disease, nerve damage, kidney failure and blindness. Patients typically die of a complication rather than of diabetes itself.

"Between 65 percent and 80 percent of all the deaths from diabetes occur due to cardiovascular disease," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic in Ohio and lead author of the study. "Obviously, a drug for diabetes that increases the risk of heart disease is a serious public health concern."

Six million Americans have taken Avandia since it was approved by the FDA in 1999, according to GlaxoSmithKline. About 1 million people are currently taking it in the U.S.

In the new study, Nissen and Cleveland Clinic statistician Kathy Wolski pooled the results from 42 clinical trials comparing Avandia to rival diabetes medications or a placebo.

Because the researchers used secondhand data, they were not able to address questions such as how long it took for Avandia to impact heart health or how big a dose was needed to see an effect.