October 26, 2015
On Monday, the U.S. Food and Drug Administration (FDA) announced that it has not found an increased risk of cardiovascular events and death linked to a medication used to treat Parkinson’s disease.
The FDA issued a warning to that effect in August 2010, suggesting a possible link between the increased risk and the use of entacapone (Comtan) and the combo drug entacapone, carbidopa, and levodopa (Stalevo).
The FDA required Novartis to study the risk, which they did in patients ages 18 to 64. The results of that along with an additional study, which looked at patients that were at least 65, showed that the risk was not there.
The drug labels will not change.
Click here to read the full announcement.
1. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone. www.fda.gov. 2015 Oct 26.