Safety Alerts & Recalls
What does this mean?
At this time, the FDA has not concluded that Stalevo or Comtan increases the risk of heart attack, stroke, or heart-related death. However, the FDA will continue to review the available information and explore additional ways to assess the heart related safety of Stalevo. The FDA will update the public as soon as its safety review is complete.
In the mean time, if you are taking Stalevo or Comtan, this is a good reminder to regularly review the risks and benefits of your medicine with your doctor. Make sure your doctor knows if you have a history of heart disease. You should continue to take your medicines as directed by your doctor. If you have any questions or concerns about Stalevo or Comtan, please talk to your doctor.
FDA: Ongoing Safety Review of Stalevo and Possible Increased Risk of Heart Attack and Stroke
The U.S. Food and Drug Administration (FDA) is reviewing data from several clinical research studies that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for heart attack, stroke, and heart-related death compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet).
Both Stalevo and Sinemet are effective treatments for the symptoms of Parkinson's disease. Adding entacapone to carbidopa/levodopa can lead to a greater degree of improvement in some of the symptoms of Parkinson's disease.
Stalevo contains a combination of the active ingredients entacapone, carbidopa, and levodopa. Entacapone is also available as a single-ingredient product sold under the brand name Comtan. Both Stalevo and Comtan are used to treat symptoms of Parkinson's disease.
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