Anemia drug labels rewritten with stronger risk warnings

Warning labels on anemia drugs made by Amgen Inc. and Johnson & Johnson have been strengthened to reflect concerns that they boost the risk of heart attacks, stroke and death, regulators said Thursday.

Millions of cancer and kidney disease patients take the drugs, known as erythropoiesis-stimulating agents. EPO drugs include Amgen’s biggest drug, Aranesp, and an older version, Epogen, and J&J;’s Procrit.

The class of drugs has been under a cloud since a study showed increased risk of death in cancer patients whose anemia was not caused by chemotherapy. There have also been concerns that the drugs were being overused in dialysis patients.

The Food and Drug Administration said the labeling changes reflect new data on potential adverse effects.

“The FDA strongly recommends that prescribers talk to their patients about the risk,” said Dr. Richard Pazdur, head of the FDA’s cancer division.

Aranesp is approved to treat anemia associated with chemotherapy and kidney disease. Epogen is used to treat anemia associated with kidney disease. The two drugs generated sales of $4.1 billion in 2006.

But worldwide Aranesp sales fell 23% to $818 million in the third quarter as doctors stopped using it in cancer patients who were not undergoing chemotherapy and as other regulatory and reimbursement changes began to take a toll.

Epogen sales fell 5% to $602 million while sales of Procrit plunged 27% to $380 million.