The Food and Drug Administration, under fire from a new Senate report questioning the safety of GlaxoSmithKline PLC’s diabetes drug Avandia, told doctors that patients taking the medicine should stay on it unless their doctors say otherwise.
Rep. Rosa DeLauro (D., Conn.), the chairwoman of the House appropriations panel that controls the FDA’s budget, said: “I strongly urge the FDA to remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the safety and effectiveness of the drug.”
Mrs. DeLauro said it was “reprehensible that many people might have suffered heart attacks or heart failure as a result of taking this drug, especially if a safer alternative exists.” A similar drug, Takeda Pharmaceutical Co.’s Actos, has been shown to lower glucose levels as well as Avandia, while being linked to a lower risk of cardiovascular problems.
A report released by the Senate Finance Committee said Glaxo knew of an increased risk of heart attack linked to Avandia for several years, but played down potential problems to the public and the FDA. The committee was critical of the FDA’s support of Avandia, and the report included studies by two FDA doctors who said in 2008 the drug should be removed from the market.
Last June, Glaxo released the results of a study called Record, which it said showed there was no serious risk of heart attack or death from Avandia. FDA’s Dr. Woodcock said the agency got the results of the trial in mid-2009 and was continuing to review them. The FDA has scheduled a meeting of outside advisers in July to discuss Avandia.
On the conference call, Robert Vigersky, president of the Endocrine Society, questioned why the meeting wouldn’t be held until July when the agency received the data last year. “Is there any way this could be accelerated, given all the publicity and uncertainty that we have?” asked Dr. Vigersky, whose nonprofit group represents diabetes specialists.
Dr. Woodcock said the FDA needed time to “look very closely” at the Record study. Critics have said the Record study didn’t enroll enough patients to reach statistically significant conclusions and wasn’t designed to review serious potential cardiovascular issues.
he American Diabetes Association recommended in 2008 that doctors use other drugs instead of Avandia in light of potential heart problems.
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