Saturday, March 27, 2010

Twissija dwar Simvastatin (Zocor)

Aħbar mill-Amerika dwar mediċina użata lokalment.

High-Dose Simvastatin Associated With Increased Risk for Myopathy, FDA Warns

Emma Hitt, PhD

March 19, 2010 — Simvastatin (Zocor, Merck/Schering-Plough Pharmaceuticals), used at the highest approved dose of 80 mg, is associated with an increased risk for myopathy, including rhabdomyolysis, according to the US Food and Drug Administration (FDA).

The alert sent today from MedWatch, the FDA's safety information and adverse event reporting program, was based on a review of data from the large clinical Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. Other sources, including data from clinical trials, observational studies, and adverse event reports, as well as data on prescription use of simvastatin, are under review.

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