|10-20-2005, 09:30 PM||#1|
Join Date: Jul 2001
Study: Diabetes pill can double risk of death, heart attack, stroke
CHICAGO, Illinois (AP) -- A new diabetes pill that appeared headed for federal approval can double the risk for deaths, heart attacks and strokes, according to an independent analysis rushed online Thursday because of public safety concerns.
Researchers with the Cleveland Clinic analyzed the data the FDA made public before the panel vote and found that patients taking Pargluva faced double the risk of death, heart attack or stroke, compared with those on dummy pills or a similar drug.
If the analysis is correct, the drug could have meant a "public health catastrophe," said one of the researchers, Dr. Steven Nissen, a prominent heart specialist with Cleveland Clinic.
"It is beyond me why individuals who are supposed to be overseeing the safety of the public would take a chance when it's not necessary," said Dr. Catherine DeAngelis, JAMA's editor in chief. "It's not like there are not other drugs that can be used" for diabetes.
An FDA spokeswoman said agency officials do not comment on pending drug applications. Calls seeking comment from Merck and Bristol-Myers Squibb were not immediately returned. More:
I wonder why they don't take more care before giving it their approval.
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