This week, the U.S. Food and Drug Administration (FDA) announced that there is no clear evidence linking an increased risk of cardiovascular events with the drug Stalevo.
The FDA initially issued a warning against Stalevo in 2010, after clinical trial data had hinted at the possibility of increased cardiac risk with the drug. Stalevo is a combination drug consisting of a mix of carbidopa,levodopa and entacapone. As carbidopa and levodopa had not been previously shown to increase cardiac risk, it was thought the addition of entacapone to the drug could be responsible for the cardiac effects.
However, two further studies by Novartis, the manufacturer of Stalevo, found that addition of entacapone did not lead to an increased risk of cardiovascular events. The FDA has since confirmed that the initial results were potentially due to chance and do not represent a true risk of Stalevo. Recommendations for the usage of this drug remain unchanged.