A federal regulatory panel today agreed that GlaxoSmithKline's controversial diabetes drug Avandia increases the risk of heart attacks and other cardiovascular problems.
But the panel also said that Avandia doesn't increase the risk of death compared with other treatments for the disease, Bloomberg News reported.
The panel of Food and Drug Administration reviewers voted 21-3 that clinical trial data on Avandia suggests more heart risks than other medicines, Bloomberg reported. Nine panel members said they didn't have enough data to weigh the potential heart risks.
The panel said there wasn't enough evidence to determine whether Avandia increased a patient's risk of dying compared with a rival drug.
The advisers are considering in a series of votes whether available Avandia research is sufficient to determine the risk of the drug approved in 1999.
The panel is expected to recommend later today whether Avandia should be pulled from the market, slapped with stronger warnings or left alone. The FDA typically follows its panels' recommendations, but doesn't have to.
GSK officials say the drug is safe. The company wants to avoid the financial hit, legal hassle and PR headache that would come from withdrawing the drug.
Dr. Kenneth D. Burman, the committee’s chairman, started the afternoon’s sessions by emphasizing that time was very limited and that the day’s discussion must end at 5 p.m., the New York Times reported. That point led to a murmur of pleased agreement from the scrum of reporters covering the meeting.
Read today's story about local Avandia patients and doctors online here.