March 14, 2005: FDA Rejects Consumer Group’s Petition to Ban Crestor
The US Food and Drug Administration or FDA negated the March 2004 petition to ban Crestor. Public Citizen, a national non-profit consumer advocacy association, requested FDA to ban Crestor right away, saying that cases of severe muscle damage known as rhabdomyolysis, were common results to patients who are taking Crestor compared to other patients who were taking similar medicines. In the recent update about Crestor, FDA said that it does not look that the risks are higher in Crestor rather than other statin drugs available in the market.
March 2, 2005: FDA Provides Updated Information on Crestor
FDA released a public health advisory, patient information sheet, and a doctor’s information sheet which explained the risks and benefits of using Crestor. FDA provided the information about decreasing the risk of rhabdomyolysis which is characterized by muscle damage due to the use of Crestor. Furthermore, Crestor has now labeling that encourages lower doses for those who have higher risks of developing detrimental medical conditions which include kidney failure.
December 22, 2004: FDA Bans Misleading Crestor Ads
A letter from FDA was sent to Crestor manufacturer, AstraZeneca Pharmaceuticals, declaring that the company’s printed advertisement gave false and misleading safety claims about Crestor. According to FDA, the advertisement reduces the risks related with Crestor and wrongly inferred that FDA did not believe that Crestor posed a safety concern.