Study raises alarm about potential new diabetes drug's safety
NEWS IN BRIEF — Posted Nov. 7, 2005
A diabetes drug being considered by the Food and Drug Administration increases death and major cardiovascular events and should not be approved by the agency, according to a study published online Oct. 20 by the Journal of the American Medical Association.
Cleveland Clinic Foundation researchers reviewed the documents considered by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee that recommended muraglitazar (Pargluva) for approval at its September meeting. The agency since has issued an approvable letter for the drug and requested additional data related to cardiovascular safety.
"We are eager to begin discussions with the FDA to address more fully the cardiovascular safety profile of the compound and to determine what additional information may be necessary," said Tony Plohoros, Bristol-Myers Squibb corporate spokesman.
The study suggested that the drug could more than double the risk of death, heart attack and stroke, and researchers are particularly concerned that most of these events occurred after patients had been on the drug for a relatively short period of time.
"Muraglitazar should not be used or approved to treat patients with diabetes until an appropriate dedicated trial to assess cardiovascular outcomes is performed," the authors wrote.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/11/07/hlbf1107.htm.