Safety Alerts & Recalls
What does this mean?
At this time, the FDA has not concluded that Stalevo or Comtan increases the risk of developing prostate cancer. 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 ask your doctor at your next appointment if you are current with your routine prostate screenings.
You should continue to take your medicine as directed by your doctor or other healthcare professional. If you have any questions or concerns about Stalevo or Comtan, please talk to your doctor or other healthcare professional.
The FDA Issues Drug Safety Communication: Ongoing Safety Review of Stalevo and Possible Development of Prostate Cancer
The FDA notified healthcare professionals and patients that it is reviewing data from a long-term clinical study called Stalevo Reduction in Dyskinesia Evaluation - Parkinson's Disease (STRIDE-PD), that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer. In this trial, patients taking Stalevo (a combination medicine with entacapone, carbidopa, and levodopa) were compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication also used to treat Parkinson's disease. Other studies evaluating Stalevo or Comtan (entacapone) did not find an increased risk of prostate cancer. The FDA is still reviewing the available information and will notify the public when the review is complete.
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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