Tuesday, May 8, 2007

Further FDA Concerns About Anemia Drugs Aranesp, Procrit, and Epogen

Article in the Wall Street Journal -- FDA Is Concerned With Risks To Cancer Patients on Anemia Drugs, by Peter Loftus.  Here's an excerpt:

Amgen Inc. and Johnson & Johnson may have to further limit the targeted patient population and dosing levels for popular anti-anemia drugs to reduce risks to cancer patients, U.S. regulators said Tuesday.

Such moves could cut into sales for the blockbuster drugs. Already, safety concerns have slowed the growth of Amgen's Aranesp sales. Amgen relies on Aranesp and another anemia drug for nearly half of its revenue.

The Food and Drug Administration raised concerns about Aranesp and J&J's Procrit ahead of an agency meeting of outside experts scheduled for Thursday. The panel will consider whether to further modify the drugs' product labeling in the wake of recent safety concerns.

In documents posted on the agency's Web site Tuesday, the FDA said: "Further modifications to product labeling may be appropriate to minimize risks to patients, through restrictions of the indicated patient population or further limitations on dosing to achieve the minimal hemoglobin level necessary to avoid transfusions."



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