FDA To Review Data That Find Anemia Drugs Increase Death Risk, Tumor Growth In Cancer Patients

Main Category: Cancer / Oncology
Also Included In: Blood / Hematology;  Women's Health / Gynecology;  Breast Cancer
Article Date: 07 Jan 2008 - 0:00 PDT

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FDA on Thursday said it will review new data on Amgen and Johnson & Johnson's anemia drugs Aranesp, Epogen and Procrit that found the drugs can increase the risk of death and tumor growth in women with breast or cervical cancers who are taking the drugs to treat anemia caused by chemotherapy, the Wall Street Journal reports. FDA said it "may take" additional action based on two new studies of the drugs -- known as erythropoiesis-stimulating agents -- 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 and cervical cancers, as well as patients with 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, conducted 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.

According to the Los Angeles Times, FDA last year added a black box warning to the drugs' labels after six studies in recent years found that they can lead to increased 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). FDA said it was not aware of the new data when it issued the black box warnings in November 2007. An FDA panel of cancer experts is expected to consider the new data during a meeting in March, the AP/CNNMoney.com reports (AP/CNNMoney.com, 1/3).

Reaction

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). Woodcock in a statement recommended that "health care providers review the risks and benefits" of the drugs before administering them (AP/CNNMoney.com, 1/3).

Roger Perlmutter, executive vice president of research and development at Amgen, in a December 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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