|In 2007, GlaxoSmithKline's Avandia heightened concerns about diabetes drugs increasing heart attack risks. (JB Reed/Bloomberg News)|
FDA seeks new study of diabetes drug
SILVER SPRING, Md. - A federal panel said a diabetes drug from Bristol-Myers Squibb appears free from heart problems seen with similar drugs but said long-term studies should be done after approval to confirm its safety.
Bristol-Myers and partner AstraZeneca have asked the Food and Drug Administration to approve their drug Onglyza for millions of Americans with Type 2 diabetes. The drug is the first to go before the panel of diabetes experts since the agency issued new safety guidelines for diabetes treatments last year. Concerns about heightened risks of heart attack with GlaxoSmithKline's blockbuster pill Avandia created a storm for FDA and drug makers in 2007.
The FDA panel voted 10 to 2 that the companies' data do not suggest the drug hastens heart attack, stroke, and other problems. But panelists voted unanimously that the company should be required to conduct a long-term study in high-risk patients, including the elderly, to assure the drug's heart safety.
"Our primary goal is to protect the patient, and I just don't think there's enough data in the studies to be absolutely certain that there is no risk," said panel chairman Kenneth Burman.
The FDA is not required to follow the group's recommendation. A final decision is expected by April 30.