New Studies on Anemia Drugs' Risks

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FDA is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. These two studies were not among the six described in the revised labeling that was approved by FDA on Nov. 8, 2007, which strengthened warnings about ESAs in cancer patients.

All eight studies together show more rapid tumor growth or shortened survival for patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers that received ESAs, compared to those patients who did not receive the treatment.

"FDA is reviewing these data and may take additional action," says Janet Woodcock, M.D., FDA's Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, and Acting Director of the Center for Drug Evaluation and Research. "In the meantime," she says, "FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients."

FDA plans to discuss this new data and revisit the risks and benefits of using ESAs in patients with chemotherapy-induced anemia at a public advisory committee meeting in the next few months.

What Are ESAs?

ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. FDA has approved the use of ESAs for treating anemia in patients with chronic kidney failure, cancer patients whose anemia is caused by chemotherapy, and those infected with the human immunodeficiency virus (HIV) whose anemia is caused by the HIV drug AZT (zidovudine). ESAs are also approved to reduce the number of transfusions during and after major surgery.

What Has FDA Done?

FDA approved revised boxed warnings and other safety-related product labeling changes for ESAs in November and March 2007. Safety concerns regarding ESAs also have been discussed during advisory committee meetings in 2004 and 2007, and labeling was revised in 1997, 2004 and 2005 to reflect new safety information.


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