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Crestor: 118 user reviews - DailyStrength Join | Help | Sign In 0-9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z FDA Public Health Advisory for Crestor (rosuvastatin) Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Astra-Zeneca Pharmaceuticals today released a revised package insert for Crestor (rosuvastatin) (link to FDA approved labeling). The changes to the label include results from a Phase 4 pharmacokinetic study in Asian-Americans and highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. At this time, the FDA is also making statements about the muscle and kidney safety of Crestor based on extensive review of available information.Crestor, a member of a class of cholesterol-lowering drugs commonly referred to as �statins�, was approved in the U.S. in August 2003, based on review of an extensive clinical database involving approximately 12,000 patients. These data supported the safety and efficacy of Crestor for use in lowering serum cholesterol, but also showed that Crestor, like all statins, rarely could cause serious muscle damage (myopathy and rhabdomyolysis). In the approved labeling, the FDA identified in the WARNINGS section of the product label those patients in whom more careful monitoring was warranted when prescribed Crestor. In a section titled: �Myopathy/Rhabdomyolysis�, the label states that patients who are of advanced age ( 65 years), have hypothyroidism, and/or renal insufficiency should be considered to have a greater risk for developing myopathy while receiving a statin. Physicians are warned to prescribe Crestor with caution in these patients, particularly at higher doses, as the risk of myopathy increases with higher drug levels.Crestor Safe and Effective When Used According to Prescribing InformationConclusions from a review published in Circulation today regarding CRESTOR are misleading, and unfortunately create unnecessary alarm for patients who need this medication to lower their cholesterol. The FDA has access to the most complete data set and according to their conclusion, "[o]ur review of all of the available evidence (including preclinical data, pre-marketing clinical studies, Phase 4 clinical studies, and post-marketing adverse event reports) indicates that CRESTOR does not pose a risk of muscle toxicity greater than the other approved statins, and that with respect to renal toxicity, there is no convincing evidence that CRESTOR poses a risk of serious renal injury." CRESTOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women who are pregnant or may become pregnant, and in nursing mothers. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with CRESTOR and with other drugs in this class. The 40-mg dose of CRESTOR is reserved for those patients who have not achieved LDL-C goal at 20 mg. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment.
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