F.D.A. Panel Votes to Continue Use of Anemia Drugs
ANDREW POLLACK
A federal advisory panel, ∈ response to mounting safety concerns, called Thursday for additional restrictions on the use of anemia drugs by cancer patients.
The recommendation by a committee that advises the Food and Drug Administration could lead to an additional decline ∈ sales for the drugs: Aranesp, made by Amgen, and Procrit, made by Johnson & Johnson.
But the manufacturers avoided the outcome they most feared — a recommendation that the drugs not be used by any cancer patients. That probably would have cost each company at least $1 billion ∈ sales.
"They dodged the really big bullet, but they still took some damage," said Geoffrey C. Porges, a biotechnology analyst at Sanford C. Bernstein & Co.
The F.D.A. is expected to revise the drugs' labels ∈ consultation with the manufacturers. The agency does not have to adhere to the recommendations of its committees, though it usually does.
Patients take the drugs to counter the anemia caused by chemotherapy. The meeting was held because clinical trials have suggested the drugs might worsen some cancers. However, those studies involved doses higher than those typically used by patients.
The companies argued that it was not clear the drugs were dangerous and that they should remain available because they help patients avoid blood transfusions, which carry their own risks.
From: Times Digest, March 14, 2008.
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