Mar 7, 2008 6:10 pm US/Eastern
FDA Adds Death, Tumor Warnings To Anemia Drugs
WASHINGTON (AP) ―
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.
Since FDA began scrutinizing the drugs last March, shares of Amgen have sunk 27 percent. U.S. sales of its anemia treatments fell 25 to $6.3 billion for the year.
Wall Street analysts expect sales to fall further in 2008 following next week's review by FDA's experts. The panel could recommend halting use of the drugs for certain types of cancer patients, or in all cancer patients.
If FDA removes only some cancer indications, Amgen sales this year would fall another $150 million to $250 million to just over $6 billion, according to estimates by Goldman Sachs' analyst May-Kin Ho.
Shares of Amgen Inc. rose 1.02 cents, or 2.3 percent, Friday in after hours trading, following an earlier close at $44.18.
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