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www.fdanews.com/articles/129947-fda-reviewing-heart-risk-data-for-parkinson-rsquo-s-drug-stalevo

FDA Reviewing Heart Risk Data for Parkinson’s Drug Stalevo

September 1, 2010
The FDA is evaluating clinical trial data that suggest Orion Pharma and Novartis’ Parkinson’s drug Stalevo may be associated with a slightly increased risk for cardiovascular (CV) events. The data are from a meta-analysis that combined CV-related findings from 15 clinical trials comparing Stalevo (carbidopa/levodopa/entacapone) with Merck and Bristol-Myers Squibb’s Sinemet (carbidopa/levodopa), the FDA says. CV events are not uncommon in people with Parkinson’s disease in the age range studied in the trials, and many of the events occurred in a single trial.
Washington Drug Letter