The FDA will review clinical trial data from a four-year study conducted by Orion to see if patients taking Stalevo, a Parkinson's disease medication, may be at an increased risk for developing prostate cancer.
The FDA said the review of Stalevo is ongoing, and no conclusions or recommendations about the use of this drug have been made. Prior trials of shorter duration evaluating Stalevo did not find an increased risk of prostate cancer.
A prior trial showed 3.7% of men who took Stalevo contracted prostate cancer, compared to 0.9% of those taking Sinemet.
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