AstraZeneca Reconfirms the Safety and Efficacy Benefits of CRESTOR®
November 18, 2004 - Wilmington, DE - Patient safety is the number one priority at AstraZeneca. Companies and regulators have a duty to scrutinize all medicines closely. In the case of CRESTOR® (rosuvastatin calcium), the application for approval was one of the most extensive ever for a statin involving more than 12,000 patients, and was also unanimously recommended for approval by the FDA’s advisory board in July of 2003.
To date more than 45,000 patients have received CRESTOR in clinical trials, more than 12 million prescriptions have been written worldwide, and more than 3.5 million patients have been prescribed the drug. Based on these data, we are fully confident in the safety profile of CRESTOR, which has now been approved in more than 65 countries worldwide. Latest information on CRESTOR safety, as well as clinical data, updated as recently as last Friday, is available on www.rosuvastatininformation.com.
To date, the FDA has not given the company any indication of a major concern regarding CRESTOR, and the comments today are inconsistent with past public statements from the FDA and our understanding of its current view of the safety and efficacy of CRESTOR.
For journalists interested in speaking to AstraZeneca, one-on-one interviews will be offered with AstraZeneca’s medical staff on Thursday, November 18th. Please contact Emily Denney at 302-885-3451 to schedule a time.
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 10 mg is the usual recommended start dose for patients new to statin treatment and also for those switching to CRESTOR from other statins regardless of prior dose. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
In clinical studies, CRESTOR was generally well-tolerated. The most common side effects are muscle pain, constipation, weakness, stomach pain and nausea. These are usually mild and tend to go away. Doctors will perform blood tests before and during treatment with CRESTOR to monitor for liver function. Patients are encouraged to tell their doctor if they are taking any medications, including cyclosporine, warfarin, gemfibrozil or antacids. CRESTOR is not right for everyone, including women who are nursing, pregnant, or who may become pregnant, or anyone with liver problems. Unexplained muscle pain, tenderness or weakness could be a sign of a rare but serious side effect and should be reported to a doctor right away. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes.
Full prescribing and product information for CRESTOR is available by calling the AstraZeneca Information Center at 1-800-236-9933 or by visiting www.crestor.com.
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 $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 11,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit: www.astrazeneca-us.com