FDA Taking Another Look At Safety of Anemia Drugs

A Food and Drug Administration advisory panel will review the appropriate doses of certain anemia drugs, which have been linked to increased risks of heart attacks, blood clots, and stroke.

Amgen Inc.’s Aranesp and Epogen and Johnson & Johnson’s Procrit are among the drugs set to face renewed FDA scrutiny after studies showed high amounts of the drugs can be harmful. The FDA’s intention to convene an advisory panel meeting was announced today in a commentary published in the New England Journal of Medicine, according to published reports. No date for the meeting has been announced, the FDA said.

The FDA often calls on panels of medical experts to advise the agency on approvals of new drugs or to establish suitable doses of approved drugs. While the FDA is not required to follow the recommendations of its panels, most of the time, it does so.

Aranesp, Epogen, and Procrit belong to a class of drugs called erythropoiesis-stimulating agents (ESAs), which are commonly used to boost hemoglobin (an element of red blood cells) to treat anemic patients.

It is suspected that using high doses to get hemoglobin to normal levels may increase the risk of heart attacks and strokes rather than lower it, FDA officials said. A suspected link between high doses of the drugs and cardiovascular risks was first reported in about 2007.

“Randomized trials have endeavored to show that using ESAs to raise hemoglobin concentration to higher targets improves clinical outcomes,” Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, and his colleagues said in a commentary. “Unfortunately and unexpectedly, all results have suggested the opposite.”

One recent study of about 4,000 patients found those taking Aranesp are at greater risks of blood clots and strokes when they also have kidney disease and diabetes.

No related posts.