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FDA Panel Wants Anemia Drug Warnings

Experts Concerned Drugs Are Overprescribed Despite Risks
By
WebMD Health News
Reviewed by Louise Chang, MD

May 10, 2007 -- An expert panel on Thursday urged the FDA to further rein in doctors' use of drugs that stimulate red blood cells because of mounting evidence that the medications cause some patients to die early.

The experts called for new warnings on anemia drugs used to boost production of red blood cells. The move comes only weeks after the agency warned the public that the drugs may speed cancer growth and spur heart attacks and other cardiovascular problems.

The drugs were approved because of their ability to lower the need for blood transfusions in cancer patients who have anemia (low red blood cell count) due to chemotherapy. But clinics and hospitals have seen an explosion in use of these drugs that FDA scientists and cancer experts say has gone beyond the state of scientific knowledge.

Experts Thursday complained that aggressive industry marketing to doctors and patients has prompted overuse of the drugs and may be contributing to safety problems.

In March, the FDA placed "black box" warnings on the three drugs available in the U.S.: Epogen, Procrit, and Aranesp. The warnings alert patients and doctors to lessen the risk of blood clots by using the lowest dose of medication needed to avoid the need for blood transfusion.

The boxed warning also includes information that the drugs can increase the risk of death or serious medical complication such as heart attacks and strokes if used too aggressively in some patients.

Overuse Alleged

Most evidence suggests that the increased risks are the result not of recommended use, but instead are due to overdosing and overprescribing to a largely unstudied swath of patients. As many as 450,000 American patients are taking the drugs, which can cost $1,000 per treatment.

Many doctors prescribe the drugs to improve quality of life by helping with the fatigue often resulting from anemia. But FDA scientists said Thursday that no scientific studies have shown the drugs improve cancer patients' quality of life.

At the same time, evidence from at least two recent studies showed they may promote tumors and cause early death, says Vinni Juneja, an agency safety official.

"FDA believes there should be a reconsideration of the risk to benefit ratio ... in cancer patients," he says.

Industry scientists maintain that the drugs can improve quality of life and don't spur cancer growth.

"We do not have data that tumor progression is an issue as a result of erythropoietin treatment. We simply don't," says Roger M. Perlmutter, MD, executive vice president of Amgen, which sells Epogen.

Marketing Questioned

But agency officials and experts blamed aggressive industry marketing for promoting the drugs as a way to boost energy -- a claim not approved by the FDA.

Television and print advertisements widely distributed by Procrit maker Johnson & Johnson urged patients to seek out the drug as a way to improve vigor.

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