FDA Knew About Potentially Lethal Diabetes Drug Since Last August, Said Nothing

The Type 2 diabetes drug Avandia may have caused heart attacks in “tens of thousands of people,” according to a study by the Cleveland Clinic. The study showed that patients on Avandia had a 43% higher risk of heart attacks, and a 64% increase in cardiovascular death. The maker of the drug, GlaxoSmithKline, separately told the FDA of the risk last August, but neither the drug maker nor the Agency warned the public.

The study was outed yesterday on the New England Journal of Medicine’s website. The editors of the journal and the study’s lead author both warned that the research methodology left the “findings open to interpretation.”

Even though the FDA was aware of the risks since last summer,

…the publication of the study on the journal’s Web site prompted the Food and Drug Administration to issue a public safety alert and advise users of the drug — an estimated million people in this country and two million worldwide — to consult their doctors about the potential cardiovascular risks.

Congress wants to know why the FDA can’t walk and chew gum, after the jump…

The FDA is trying to defend itself against comparisons to its handling of Vioxx by pointing out that it is almost done with its own independent review of the study. That isn’t enough for several members of Congress.

The House Energy and Commerce Committee has already asked why the Agency couldn’t warn the public while the study was underway. Congressman Henry Waxman, Chair of the House Committee on Oversight and Government Reform, plans to haul the head of the FDA, Andrew von Eschenbach, before his committee for questioning.

Patients on Avandia may want to call their doctor. — CAREY GREENBERG-BERGER

Heart Attack Risk Seen in Drug for Diabetes [NYT]
Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes [New England Journal of Medicine]