FDA Reports New Risks Posed by Anemia Drugs

ESAs can spur faster cancer growth and earlier death, agency says

By Steven Reinberg
HealthDay Reporter

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THURSDAY, Jan. 3 (HealthDay News) -- Two new studies offer further evidence of the health risks posed by the anemia drugs known as erythropoiesis-stimulating agents (ESAs), U.S. officials announced Thursday.

The studies showed that patients with breast or advanced cervical cancer who took the drugs as treatment for chemotherapy-induced anemia died sooner or had more rapid tumor growth than patients not on the drugs, U.S. Food and Drug Administration officials said in a prepared statement.

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On Nov. 8, the FDA approved new "black box" warnings on labels of the three ESAs -- Aranesp, Epogen and Procrit. The warnings detailed the dangers to patients with cancer and patients with chronic kidney failure. Those dangers include heart attack, stroke, heart failure and cancer tumor growth and shortened survival, the FDA said.

The drugs had been touted as a treatment to lessen fatigue and improve quality of life among cancer, HIV and other patients with anemia, but the revised label said there was no evidence to back that claim. The label change was the fifth such change since Procrit was approved in 1989, FDA officials said.

Results of the two studies released Thursday were not among the six studies that led to the Nov. 8 label revision. Taken together, all eight studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared to patients who didn't get this therapy, the FDA said.

The FDA said it plans to discuss the new findings and re-examine the risks and benefits of ESAs for patients with chemotherapy-induced anemia at a public advisory committee meeting in the next few months.

"This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications," Dr. Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, said in the statement.

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