March 14, 2005: FDA Rejects Consumer Group's Petition to Ban Crestor
The U.S. Food and Drug Administration (FDA) denied a March 2004 petition to ban Crestor. Public Citizen, a national non-profit consumer advocacy organization, had asked the FDA to immediately ban Crestor, claiming that cases of serious muscle damage (rhabdomyolysis) were more common in Crestor patients than in patients who took similar medicines. In its latest Crestor alert, the FDA stated that "it does not appear that the risk is greater with Crestor than with other marketed statins." Click here to read more information from Public Citizen.
March 2, 2005: FDA Provides Updated Information on Crestor
The FDA issued a public health advisory, a patient information sheet, and a healthcare professional information sheet explaining the identified risks and benefits of Crestor. The FDA has provided information about reducing the risk of rhabdomyolysis (serious muscle damage) associated with Crestor use. Additionally, Crestor's new labeling urges lower doses for those at a greater risk of developing harmful medical conditions, including kidney failure. Click here to read the FDA Public Health Advisory for Crestor.
December 22, 2004: FDA Bans Misleading Crestor Ads
The FDA sent a letter to Crestor manufacturer AstraZeneca Pharmaceuticals, stating that the company's print advertisement made false or misleading safety claims about Crestor use. According to the FDA, the advertisement minimizes the risks associated with Crestor and incorrectly implies that the FDA does not believe that Crestor poses a safety concern. Click here to read more from the FDA [PDF file].
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