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FDA Expands Warnings on Anemia Drugs
Friday March 7, 6:46 PM EST
WASHINGTON (AP) — Drug maker Amgen Inc. said Friday it expanded black box warnings about risks of death and tumor growth of its blockbuster anemia drugs.
The warnings approved by the Food and Drug Administration state that the company's drugs increased death and accelerated tumor growth in patients with early stage breast cancer and cervical cancer. Earlier labeling warned of similar risks in other types of cancer.
The changes apply to Thousand Oaks, Calif.-based Amgen's Aranesp and Epogen, as well as Johnson & Johnson's Procrit. The drugs treat the blood-disorder anemia in patients with kidney failure and those on chemotherapy. Amgen manufacturers all three, though New Brunswick, N.J.-based J & J sells Procrit.
The language states that the problems occurred when doctors treated patients with elevated levels of the drugs, which increase red blood cell levels.
The action came less than a week before a meeting where government advisers are scheduled to review the risks of the blockbuster medications.
http://finance.myway.com/jsp/nw/nwdt_rt.jsp?section=news&feed=ap&src=601&news_id=ap-d8v8t8no0&date=20080307
Friday March 7, 6:46 PM EST
WASHINGTON (AP) — Drug maker Amgen Inc. said Friday it expanded black box warnings about risks of death and tumor growth of its blockbuster anemia drugs.
The warnings approved by the Food and Drug Administration state that the company's drugs increased death and accelerated tumor growth in patients with early stage breast cancer and cervical cancer. Earlier labeling warned of similar risks in other types of cancer.
The changes apply to Thousand Oaks, Calif.-based Amgen's Aranesp and Epogen, as well as Johnson & Johnson's Procrit. The drugs treat the blood-disorder anemia in patients with kidney failure and those on chemotherapy. Amgen manufacturers all three, though New Brunswick, N.J.-based J & J sells Procrit.
The language states that the problems occurred when doctors treated patients with elevated levels of the drugs, which increase red blood cell levels.
The action came less than a week before a meeting where government advisers are scheduled to review the risks of the blockbuster medications.
http://finance.myway.com/jsp/nw/nwdt_rt.jsp?section=news&feed=ap&src=601&news_id=ap-d8v8t8no0&date=20080307
