FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson’s disease drug en tacapone

FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

This is an update to the FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and Possible Increased Cardiovascular Risk issued on August 20, 2010.

A FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease. As a result, our recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the drug labels. Patients should discuss any questions they have with their health care professionals.

We alerted patients and health care professionals about a possible increased risk for cardiovascular events and death with Stalevo in an August 2010 Drug Safety Communication. This possible safety issue was observed in a clinical trial called the Stalevo Reduction in Dyskinesia Evaluation in Parkinson’s Disease (STRIDE-PD) and in a meta-analysis that combined the cardiovascular-related findings from 15 clinical trials comparing Stalevo to carbidopa/levodopa. Carbidopa and levodopa have been used extensively and have not been shown to have an increased cardiovascular risk. We were concerned that the entacapone in Stalevo was responsible for these cardiovascular risks because the comparison drugs do not contain this ingredient.

To better understand the significance of these findings, we required the Stalevo manufacturer, Novartis, to study the potential for
cardiovascular risk with the entacapone component of the drug. We examined the results from this required study and from one additional study and concluded they do not show an increased risk of cardiovascular adverse events with entacapone. The results observed in the original meta-analysis were driven by results of a single study (STRIDE-PD), which was not designed to assess cardiovascular risks. We believe that the meta-analysis and STRIDE-PD results are chance findings and do not represent a true increase in risk due to entacapone.

In light of the results from these two additional studies, FDA finds no evidence of an increased risk of myocardial infarction, stroke, or other cardiovascular events associated with the use of entacapone, Comtan or Stalevo. As a result, the drug labels will remain unchanged.

We urge patients and health care professionals to report side effects involving entacapone, Comtan, or Stalevo to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

To learn more, please visit: entacapone
.

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