FDA evaluating prostate cancer risk with Stalevo

The FDA has notified healthcare professionals and patients that it is evaluating data from the long-term STRIDE-PD clinical trial, that may suggest that patients taking Stalevo (carbidopa/levodopa/entacapone, from Novartis) may be at an increased risk for developing prostate cancer. This trial compared patients taking Stalevo to those receiving carbidopa/levodopa (Sinemet, from Bristol-Myers Squibb). Other controlled clinical trials evaluating Stalevo or Comtan (entacapone, from Novartis) did not find an increased risk of prostate cancer.

The 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.  The 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 provider.

Stalevo is indicated in idiopathic Parkinson's disease to substitute for equivalent doses of previously-administered carbidopa/levodopa and entacapone and to replace immediate-release carbidopa and levodopa in patients with end-of-dose "wearing-off" symptoms who are taking levodopa up to 600mg/day without having dyskinesias.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm206934.htm.