FDA Examines Anemia Drug Risks

New data on the risks of anemia drugs is being reviewed by the U.S. Food and Drug Administration (FDA), and the studies show that patients with certain types of cancer face greater danger of tumor growth and death when taking the anemia drugs -- called erythropoiesis-stimulating agents (or ESAs) and marketed under the brand names Aranesp, Epogen, and Procrit. An FDA Press Release states that "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 did not receive this treatment." FDA issued a Public Health Advisory and approved revised boxed warnings for ESAs in 2007, and plans to revisit the risks and benefits of using ESAs in certain chemotherapy patients at a public advisory committee meeting in the next few months.

• FDA Press Release on ESAs (January 3, 2008)
• FDA Public Health Advisory on ESAs (November 8, 2007)
• FDA Center for Drug Evaluation and Research
• Defective and Dangerous Products (FindLaw)