Avandia will face curbs, at least
An FDA analysis cited risks to the heart from Glaxo's drug. Advisers are to meet Monday.
GlaxoSmithKline P.L.C.'s best-selling diabetes pill Avandia has heart risks that will require restricting the drug's use, U.S. regulators said.
Avandia increased the chances of heart attacks when combined with insulin, according to a report by Food and Drug Administration staff members. The analysis, released on the FDA's Web site in preparation for an advisory panel hearing Monday, also found that Avandia's effect on the heart was no greater than that of competing drugs in other studies lasting longer than one year.
The FDA advisers will be asked whether Avandia should remain on the market or carry heightened warnings. A report in May tied Avandia to a 43 percent increased risk of heart attacks. Even before that, in February, drug-safety scientists at the FDA concluded from their own analysis that Avandia should not be used with insulin or in patients with heart disease.
"Current available information points to an increased risk of cardiovascular adverse effects," including heart failure, heart attacks, and death from heart complications, Kate Gelperin and Lanh Green, drug-safety scientists at the agency, wrote in a July 6 memo included in yesterday's FDA documents.
"A critical question to be resolved in determining appropriate regulatory action is whether the anticipated therapeutic benefit" of Avandia outweighs its demonstrated heart risks, they wrote.
Last August, GlaxoSmithKline, which has a U.S. headquarters in Philadelphia, recommended adding information to the drug's prescribing label, saying the risks caused by reduced blood flow to the heart were greater with Avandia in a review of earlier trials.
The company also wanted to include data from health insurance records that showed no increased risk with the drug. The information is given with the drug in Europe now.
Lawyers for Avandia users contend that the company rushed the diabetes drug to market without proper testing and hid its health risks.
The FDA did not act on the GlaxoSmithKline request because the findings from the two studies were conflicting and required the agency to do its own analysis, said Susan Cruzan, an agency spokeswoman. That work was completed only recently.
The recommendations for warnings and restrictions on Avandia lessen the chance that it will be pulled from the market, a step analysts and investors say is unlikely. Whether the drug will ever recover its lost sales remains in doubt, they said.
Avandia was the world's best-selling diabetes pill and GlaxoSmithKline's second-biggest drug last year, raising revenue of $3.3 billion worldwide. Sales fell 22 percent after the Cleveland Clinic reported the heart risks in the New England Journal of Medicine on May 21.