Image by Ari Herzog via FlickrShire , 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.