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Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review

Audience: Neurology, Oncology, and Family Medicine

FDA notified healthcare professionals and patients that it is evaluating data from a long-term clinical trial 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. Other controlled clinical trials evaluating Stalevo or Comtan (entacapone) did not find an increased risk of prostate cancer. FDA is still reviewing the available information and has not concluded that Stalevo increases the risk of developing prostate cancer. Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening.  FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing Stalevo and Comtan.  Patients should not stop taking their medication unless directed to do so by their healthcare professional.


[03/31/2010- Drug Safety Communication - FDA]