Crestor FDA Alerts
The FDA Alerts below may be specifically about Crestor or relate to a group or class of drugs which include Crestor.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Crestor
Statin Drugs - Drug Safety Communication: Class Labeling Change
ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels.
The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.
Read the FDA Drug Safety Communication for more information.
BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). Marketed as single-ingredient products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Also marketed as combination products, including Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release),and Vytorin (simvastatin/ezetimibe).
RECOMMENDATION: Healthcare professionals should perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. If an alternate etiology is not found, the statin should not be restarted.
Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Statin drugs and amyotrophic lateral sclerosis (ALS)[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.
The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.
Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.
[September 29, 2008 - News Release - FDA]
Crestor (rosuvastatin) - Mar 2, 2005FDA issued a public health advisory describing revisions to the WARNINGS, DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY, and PRECAUTIONS sections of the labeling. The revisions 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.
[March 2, 2005 - Public Health Advisory - FDA]
[March 2, 2005 - Drug Information Page - FDA]
[January 2005 - Revised Label - Astra-Zeneca]
Crestor (rosuvastatin) - Jun 9, 2004FDA issued a Public Health Advisory notifying healthcare professionals of a revised package insert for use in the 22 member states of the European Union (EU). The changes to the European labeling are in response to adverse event reports in patients receiving Crestor and highlight certain patient populations who may be at an increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg. These risk factors and many of the recommendations for how to minimize the risk of myopathy are already captured in the FDA approved labeling for Crestor in the U.S. FDA alerted physicians to carefully read the Crestor product label and follow the recommendations for starting doses, dose adjustments, and maximum daily doses to minimize the risk of myopathy in individual patients.
[June 09, 2004 Public Health Advisory - FDA]