Study Finds Stroke Risk From Anemia Drug Aranesp

Therapeutics Daily

A new study raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp nearly doubled the risk of stroke in people with diabetes and chronic kidney problems who are not yet sick enough to need dialysis.


The study is the largest ever of these blood-boosting drugs and the only one that compared them to a dummy treatment. The medicines have become blockbuster sellers because they lessen the need for transfusions, but their ability to prevent heart attacks, kidney failure or other problems have not been proven.


Over the last two years, the federal Food and Drug Administration has repeatedly strengthened warning labels on Aranesp, Epogen and Procrit as concerns rose that they may worsen survival in certain cancer patients, especially at higher doses. Amgen Inc. of Thousand Oaks, California, makes all three drugs, although New Brunswick, New Jersey-based Johnson & Johnson sells Procrit.


The new study tested Aranesp in a different group of patients: 4,038 people with Type 2 diabetes, kidney problems and moderate anemia _ problems that often go hand in hand. The goal was to see if the drug could prevent heart attacks, heart failure, strokes or the need for dialysis.


It not only failed to do that, but "we uncovered a risk that I think is substantial for stroke," said study leader Dr. Marc Pfeffer, a heart specialist at Brigham and Women's Hospital in Boston.


Strokes occurred in 101 patients given Aranesp and 53 patients given dummy shots. Looked at another way, the risk of suffering a stroke was about 1 percent per year in the placebo group and about 2 percent in those given Aranesp.


For many people, "this risk will outweigh its potential benefits," the study's authors conclude.


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