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FDA adds black box warning to anemia drugs
New labels on three medications tells of risks of death, tumors
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WASHINGTON - Drug maker Amgen Inc. says regulators have added new warnings about risks of death and tumor growth to its blockbuster anemia drugs.
The new warnings approved Friday by the Food and Drug Administration warn that the company's drugs increased death and accelerated tumor growth in patients with several types of cancer, including breast and cervical. Prior labeling added to the drugs in November warned of similar risks in other types of cancers.
The warnings apply to Thousand Oaks, Calif.-based Amgen's Aranesp and Epogen, as well as Procit, sold by New Brunswick, N.J-based Johnson & Johnson. The drugs treat the blood-disorder anemia in patients with kidney failure or who are undergoing chemotherapy.
Labeling approved by FDA said risks occurred when doctors treated patients with elevated levels of the drugs, which stimulate red blood cell levels.
The action by FDA and the drug makers comes less than a week before a meeting where government advisers are scheduled to review the risks of the blockbuster medications. The panel could recommend halting use of the drugs for certain types of cancer patients, or in all cancer patients.
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