FDA reviews cardiovascular risks associated with Stalevo

The FDA has notified healthcare professionals that clinical trial data suggesting that Stalevo (carbidopa, levodopa, entacapone, from Novartis) increases the risk for cardiovascular events compared to carbidopa/levodopa (Sinemet, from Bristol-Myers Squibb) is being evaluated. The FDA's decision to conduct a meta-analysis was based on findings from the Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease (STRIDE-PD) trial, which reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those receiving only carbidopa/levodopa.

At this time, the FDA's review of the potential cardiovascular risk with Stalevo is ongoing. Healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease. Patients should not stop taking Stalevo unless told to do so by their healthcare provider.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm223423.htm.