Ongoing Safety Review of Stalevo and possible increased cardiovascular risk

FDA Podcast

On August 20, 2010, the Food and Drug Administration issued a drug safety communication about the ongoing review of Stalevo and possible increased cardiovascular risk. FDA is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events, such as heart attack, stroke, and cardiovascular death, compared to those taking carbidopa/levodopa which is sold as the combination product, Sinemet.

Both Stalevo and Sinemet have been shown to be effective treatments for the symptoms of Parkinson's disease. The addition of entacapone to carbidopa/levodopa has been shown to lead to a greater degree of improvement in some of the symptoms of Parkinson's disease than treatment with carbidopa/levodopa alone.

Entacapone is also available as a single-ingredient product (sold under the brand name Comtan) to be always administered in association with carbidopa/levodopa (entacapone has no antiparkinsonian effect of its own).

It is estimated that 154,000 patients were dispensed a prescription for Stalevo from its approval in June 2003 through October 2009.

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