Amgen Drug May Increase Stroke Risk in Some: Study - Pharmaceuticals * US * News * Story

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Amgen Drug May Increase Stroke Risk in Some: Study

Topics:FDA | Pharmaceuticals

Sectors:Pharmaceuticals | Pharmaceuticals and Biotechnology

Companies:Amgen Inc

By: Mike Huckman, Reporter | 30 Oct 2009 | 08:40 PM ET

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Mike Huckman
CNBC Pharmaceuticals Reporter

A large study being published in a major medical journal says certain kidney disease patients who get the drug Aranesp to treat anemia-related fatigue may be at greater risk of having a stroke.

Researchers report in “The New England Journal of Medicine” that nearly twice as many patients who got Amgen’s Aranesp suffered a stroke versus those who were on the placebo. They also saw a higher death rate among study participants on Aranesp and who had a history of cancer.

Brigham and Women’s Hospital’s Dr. Marc Pfeffer, who led the clinical trial, says he and his colleagues don’t yet know why the stroke risk was so much higher, but in the meantime he believes use of Aranesp on this group of patients will decline.

doctor

The study, which Amgen paid for, was done on more than 4,000 people who have type 2 diabetes, chronic kidney disease and anemia, but who were not on dialysis.

Amgen says it has already shared the data with the Food and Drug Administration and that it expects the results to eventually be turned into a warning on the drug’s label. Aranesp is designed to boost red blood cells, give people more energy and cut the need for transfusions. Other recent studies showed the drug may also cause tumor growth, resulting in new FDA warnings.

In a press release, Amgen’s head of research and development, Dr. Roger Perlmutter, is quoted as saying the risks of Aranesp will outweigh the benefit in this particular patient population.