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Friday, March 9th 2007

Big Scary Warnings For Synthetic Erythropoietins And The Like…

Drugs for the anemia of say chemotherapy (I know you’ve seen the ads for Procrit on television) are getting strict warnings put on them from the FDA.

Officials of the drug agency stressed that the main safety risks of the drugs appear to occur when the drugs are used to raise hemoglobin to levels higher than 12 grams for each deciliter of blood, the level indicated in the prescribing information for the drugs.

Even then, the data showing risks are “very, very preliminary,” Dr. Patricia Keegan, director of the agency’s division dealing with biotech cancer drugs, said on a conference call with reporters today. Nevertheless, she said, the pattern in the data seemed consistent enough to merit the new warnings.

These warnings aren’t exactly new. Not that it looks like some of the patients need to be warned (Warning: Profanity).