Crestor Safe and Effective When Used According to Prescribing Information

Main Category: Cholesterol
Article Date: 28 May 2005 - 6:00 PDT

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Conclusions 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.

Conclusions from the Circulation review, based on adverse event reporting system (AERS) data gathered through September 2004, stand in direct contrast to an FDA document issued on March 14, 2005, in response to a citizen's petition.

A copy of the FDA's document can be found at: http://www.fda.gov/cder/drug/infopage/rosuvastatin/crestor_CP.pdf

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."

The Circulation report attempts to draw conclusions that simply can not be drawn from adverse event reporting data. The FDA's own disclaimer on the front page of the AERS states, "the information contained in these [adverse event] reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions."

It is important to note that the results of this study represent the conclusions of the authors only and do not represent the official position of the AHA.

CRESTOR has been prescribed almost 22 million times for more than 4.7 million patients. AstraZeneca stands fully behind the safety and effectiveness of CRESTOR when the product is used according to the prescribing information.

About CRESTOR

CRESTOR (rosuvastatin calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. Initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy. For patients with marked hypercholesterolemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.

Important Safety Information

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. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

CRESTOR is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to CRESTOR were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and nausea (1.3%).

A full copy of the prescribing information for CRESTOR is available at astrazeneca-us.com/pi/crestor.pdf or by calling 1-877-420-7249.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com