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Patients with kidney failure should not stop being treated with a group of anemia drugs despite a study showing that it can increase the risk of strokes, a US panel has said.
Advisors from the Food and Drug Administration voted in favour of maintaining the drug’s approval by 15-1, with one abstention. Although the FDA is not bound by group’s advice, it is often followed.
The Procrit, Aranesp and Epogen medicines are prescribed to patients with chronic kidney disease who are not yet sick enough to need dialysis treatment.
Their ability to increase oxygen-carrying red blood cells and reduce the need for painful blood transfusions has made them multibillion-dollar sellers. But safety warnings issued by the FDA since 2007 highlighting the risk of tumour growth and hastening death for cancer patients has caused sales to drop dramatically.
The drugs are no longer made available to patients with several types of cancers.
The FDA is reviewing the medications from biotech drugmaker Amgen after a study published last year that showed patients with kidney disease who were taking the drugs were twice as likely to experience stroke compared with those taking a dummy treatment.
The goal of the study was to show that higher doses of the drug could prevent heart attack, stroke and other heart-related problems, as had been assumed for years.
Panelists said additional studies are needed to find the ideal drug dosage for kidney disease patients.
“The label should be adjusted, but I just don’t think we have enough information to recommend a fixed dose,” said Dr Judith Hochman of the New York University School of Medicine.
Copyright Press Association 2010
The Food and Drug Administration
