Today, the US Food and Drug Administration (FDA), announced the results of its safety review of both Carbidopa/Levodopa/Entacapone (Stalevo®) and Entacapone (Comtan®) for use in Parkinson’s disease, finding that neither drug presents increased risk for adverse cardiovascular events.
Five years ago, the FDA announced a safety investigation into the drugs, after several adverse events were observed during a clinical trial called STRIDE-PD (Stalevo Reduction in Dyskinesia Evaluation in Parkinson’s Disease). The FDA went on to require the drug’s manufacturer, Novartis, to conduct reviews into the trial data and another study of the drug, to study its safety. After reviewing both, the FDA finds the evidence does not indicate increased risk for cardiac events.
The FDA also noted that seven of the eight people in the original trial experienced their adverse events six months after the PD medications in question were stopped. Additionally, most people who experienced adverse cardiac events had pre-existing risk factors for cardiovascular disease.
The FDA statement states it believes the results were “chance findings and do not represent a true increase in risk due to entacapone."
Are you taking either of these medications for PD? Consult your doctor to find the best PD medications for your treatment plan and to discuss possible side effects. If you experience adverse events or side effects from any medications, know that you can also report directly to the FDA here.