FDA Investigates Anemia Drugs

Rockville, MDThe US Food and Drug Administration (FDA) has announced it is now reviewing new data from studies that show potential risks associated with anemia drugs. Those risks include a more rapid progression of tumor growth in patients with breast cancer or advanced cervical cancers.

Back in November 2007, the FDA announced strengthened warnings regarding the anemia drugs, which are in a class of drug known as erythropoiesis-stimulating agents (ESAs). The strengthened warnings were based on six studies that found patients with certain types of cancer either died sooner than they would have or had more rapid tumor growth than patients who did not take ESAs. The two new studies were not a part of the group of six studies cited in November.

According to the FDA, "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." Furthermore, although the ESAs were used to help patients reach a hemoglobin level of 12 grams per deciliter or greater, many patients did not reach that level.

The two new studies were provided to the FDA by Amgen, the maker of the drugs—Aranesp, Epogen and Procrit—that are under review. The first study, known as PREPARE, showed that 14 percent of breast cancer patients who received Aranesp to treat their anemia had died after three years. This is compared to 9.8 percent of patients who did not receive the drug. The study also showed that patients who received Aranesp experienced faster tumor growth.

The second study was conducted by the National Cancer Institute's Gynecologic Oncology Group and involved patients who received chemotherapy and radiation for advanced cervical cancer. The results showed that 58 percent of patients who received Procrit were still alive and free of cancer growths after three years, compared with 66 percent of patients who did not take Procrit.

The FDA's review could result in more warnings on Aranesp, Epogen and Procrit. Labeling on the drugs was already changed in 1997, 2004 and 2005. In 2007, black box warnings were added to the drugs.

The latest news will probably not alleviate the confusion that many patients feel about taking anemia drugs. Many people whose loved ones died of cancer after receiving one of the anemia drugs are left wondering if they would still be alive if they hadn't taken the medications. Some are now considering lawsuits against Amgen.