FDA panel rejects approval of Bristol-Myers pravastatin/aspirin combo

By Alicia Ault

SILVER SPRING, MD (Reuters Health) – A US Food and Drug Administration (FDA) advisory committee voted 7-1, with one abstention, against approval of Bristol-Myers Squibb's Pravachol (pravastatin) and aspirin combination for patients with hypercholesterolemia who have had a heart attack or other cardiac event.

Bristol-Myers said that the more-convenient combination, Pravachol 40 mg plus 81 mg of buffered aspirin or Pravachol 40 mg plus 325 mg of buffered aspirin, might increase the number of patients taking the two separate therapies. For patients with high cholesterol and a previous cardiac event, the American Heart Association and American College of Cardiology recommend use of a "statin" drug, like Pravachol, and aspirin to prevent future events.

But panelists worried that adding an anti-platelet drug to a combination could present safety problems.

"I have grave concerns about packaging aspirin, clopidogrel, or any other anti-platelet agent with anything," said panelist Beverly Lorell of Beth Israel Deaconess Medical Center in Boston. "I don't think the issue of convenience is outweighed by the very real risk and lack of data," she said, noting that patients could have dangerous bleeding episodes while taking aspirin.

The company did not conduct any prospective trials. It presented a meta-analysis of five existing studies done to support Pravachol's efficacy. Panelists generally agreed that the analysis showed the combination's superiority in preventing further events or death, but they noted there was no way to determine the aspirin dose used or any other information about aspirin's effects.

The committee members said that patients are usually taken off of aspirin before major cardiac surgery. Those on a combination therapy would have to be switched to a different statin, which might actually add to patient inconvenience, they noted.

"Some of these concerns can be offset by intelligent use of this," argued Thomas Fleming, a panelist from the University of Washington. Fleming said that he had been leaning towards approval, but abstained from voting once he heard other panelists' worries about safety.

Bristol-Myers did show that the Pravachol/aspirin combination was more effective than either drug alone, said panelists, adding that they still could not vote for approval.

The FDA usually follows its panels' advice.

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