U.S. advisers: Restrict Amgen, J&J anemia drugs

By Lisa Richwine and Kim Dixon

GAITHERSBURG, Maryland (Reuters) - The widespread use of anemia drugs sold by Amgen Inc (AMGN.O: Quote, Profile, Research) and Johnson & Johnson (JNJ.N: Quote, Profile, Research) should be sharply restricted for cancer patients amid serious safety concerns, a U.S. advisory panel said on Thursday.

The Food and Drug Administration panel recommended against giving the medicines to patients with potentially curable cancers who are undergoing treatment, or to patients with advanced breast cancer or head and neck cancer.

"How long do patients have to continue to be exposed to a drug that we are not sure is safe?" said Dr. Judith Kramer of Duke University and a panel member.

The FDA typically takes the advice of its expert panels.

The recommendations come after eight studies found evidence of tumor growth or shorter survival for some patients given high doses of the drugs, which include Amgen's top-selling product Aranesp and J&J's Procrit.

Tens of thousands of cancer patients take the drugs for anemia caused by chemotherapy. Anemia, or low levels of red blood cells, causes fatigue and weakness.

The drugs, known as erythropoiesis-stimulating agents (ESAs), are genetically engineered forms of a protein that boosts production of red blood cells. The injectable medicines also are sold for patients with kidney disease.

The panel rejected, in a 13-1 vote, a more extreme option of recommending a complete withdrawal of all approved uses for cancer patients.