FDA’s AERS provides surprising look at statin class side effects, study shows

Quoted from http://www.modernmedicine.com/modernmedicine/Clinical+Pharmacology/FDArsquos-AERS-provides-surprising-look-at-statin-/ArticleStandard/Article/detail/747172

FDA’s AERS provides surprising look at statin class side effects, study shows

Publish date: Nov 4, 2011
By: Formulary staff
Source: Formulary News Capsules

Findings culled from a new method for aggregating and making sense of data in the FDA’s Adverse Event Reporting System (AERS) present a surprising glimpse at the postmarketing adverse event data for statins.

The study, which was conducted by AdverseEvents, Inc., using their proprietary new data sourcing method, RxFilter, found a class-wide variation in muscle-related adverse event reports. The results linked rosuvastatin (Crestor, AstraZeneca) with the highest percentage risk in 6 categories, including myopathy (general), myalgia, myositis, rhabdomyolysis, joints and tendons, muscle atrophy and injury, and muscle coordination and weakness. Pravastatin (Pravachol, Bristol-Myers Squibb) and lovastatin (Mevacor, Merck) demonstrated the best muscle-related safety profile.

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