Sunday, March 14, 2010

Fosrenol Maker Gets an FDA Warning Letter

FDA introduces an open governmentImage by Ari Herzog via Flickr

Shire , maker of a treatment for end-stage kidney failure, received an unusual warning from the FDA over its mismarketing of the drug Fosrenol.

The FDA said the company made several no-no's, which were:

* It left out the risk warnings, which include Crohn’s disease and bowel obstruction.
* It said Fosrenol was safer and more effective than other drugs, when the FDA believes there’s not enough evidence for that.
* It said Fosrenol could prevent “bone disease, heart disease or death,” when there’s no evidence for that.
* And it said Shire broadened the approved uses of the drug outside end-stage renal failure.


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