FDA reviews two futher studies of anemia drugs

WASHINGTON The Food and Drug Administration is reviewing new data from two studies that have provided further evidence of the risks of anemia drugs. The current studies focus on patients with breast and advanced cervical cancers, and were not among the six studies that were described in revised labeling approved by the FDA on Nov. 8, 2007, which strengthened warnings about erythropoiesis-stimulating agents or anemia drugs in cancer patients.

The results showed that the patients taking the drugs—to treat anemia caused by chemotherapy—died sooner or had more rapid tumor growth than similar patients who didn’t receive the drug.

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

The agency 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.