US FDA warns of increased myopathy risk with Zocor
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US FDA warns of increased myopathy risk with Zocor The US FDA is warning healthcare professionals and patients about an increased risk of muscle injury associated with the highest approved dose (80mg) of simvastatin [Zocor], compared with lower doses of simvastatin and possibly other statins.1,2 Although myopathy is a known adverse effect of the statin drug class, this new warning underscores the greater risk of developing myopathy, including rhabdomyolysis, when patients are receiving higher doses of simvastatin.1 The agency has been reviewing new data on the risk of muscle injury from clinical trials, observational studies, adverse event reports, and prescription use data to better understand the relationship between high-dose simvastatin use and myopathy.2 Preliminary SEARCH* trial results reveal that more patients receiving simvastatin 80mg developed myopathy, compared with patients in the simvastatin 20mg group; 52 vs 1 patient (0.9% vs 0.02%). Also, the agency’s preliminary analyses of the primary data suggest that 11 (0.02%) patients in the simvastatin 80mg group developed rhabdomyolysis; there were no cases among simvastatin 20mg recipients. In 2008, the FDA issued an alert notifying the public of an increased risk of rhabdomyolysis when simvastatin is used in combination with amiodarone.** * Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine trial ** see Reactions 1215 p2; 801075343 1. U.S. Food and Drug Administration. FDA Warns About Increased Risk of Muscle Injury with Zocor. Media Release : 19 Mar 2010. Available from: URL: http://www.fda.gov. 2. FDA. FDA Drug Safety Communications: ongoing safety review of high-dose Zocor* (simvastatin) and increased risk of muscle injury. Internet Document : [3 pages], 19 Mar 2010. Available from: URL: http://www.fda.gov. 801075496
0114-9954/10/1294-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved
Reactions 27 Mar 2010 No. 1294
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