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Fosrenol Maker Gets an FDA Warning Letter

Image 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.

Source: http://industry.bnet.com/pharma/10007126/fda-issues-rare-quadruple-warning-to-kidney-drug-maker-next-up-double-secret-probation/

Full post as published by A Georgia Lawyer on March 14, 2010 (boomark / email).