FDA To Review New Data On Risks Associated With Anemia Drugs

FDA on Thursday said it will review new data that show Amgen and Johnson & Johnson's anemia drugs Aranesp, Epogen and Procrit can increase the risk of death and tumor growth in women with breast or cervical cancers, the Wall Street Journal reports. The drugs -- known as erythropoiesis-stimulating agents -- are used by women to treat anemia caused by chemotherapy. FDA said it "may take" additional action based on two new studies of the drugs submitted to the agency last month by Amgen and J&J, according to the Journal. Amgen manufactures all three drugs, and Procrit is marketed by J&J unit Ortho Biotech.

According to FDA, the two new studies "provide further evidence of the risks of anemia drugs," including "more rapid tumor growth or shortened survival" in patients with breast, cervical and certain other cancers (Corbett Dooren, Wall Street Journal, 1/4). The first study involved 733 women who received chemotherapy before undergoing surgery to treat breast cancer. Among the patients who received Aranesp to treat their anemia, 14% had died after three years, compared with 9.8% of those who did not receive Aranesp. In addition, tumors grew faster in the patients who received Aranesp, according to the study.

In a separate study by the National Cancer Institute's Gynecologic Oncology Group, researchers analyzed records of advanced cervical cancer patients who received chemotherapy and radiation. The patients received either Procrit or blood transfusions as necessary. After three years, 58% of the patients who received Procrit were still living, compared with 66% of the patients who did not receive the drug.

FDA last year added a black box warning to the drugs' labels after six studies in recent years found that they can increase the risk of heart attack, stroke, heart failure and cancer tumor growth. Medicare, following the addition of the black box warning, placed limits on its reimbursements for anemia drugs (Costello, Los Angeles Times, 1/4).

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Janet Woodcock, acting director of FDA's Center for Drug Evaluation and Research, said the new data illustrate the "safety concerns" of the drugs, adding that the agency "may take additional action" to further restrict use of the drugs (Los Angeles Times, 1/4).

Roger Perlmutter, executive vice president of research and development at Amgen, in a December 2007 statement said that as new data become available, the company "will communicate the data, and where appropriate, work with the FDA to update our product labels" (Los Angeles Times, 1/4). Amgen and Ortho Biotech have said that they will work with FDA and continue to provide safety updates to health care providers (Wall Street Journal, 1/4).


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