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FDA Drug Safety Communication: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate CancerSafety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary EXCERPTS: Safety Announcement " [03-31-2010] The U.S. Food and Drug Administration (FDA) is evaluating clinical trial data that may suggest that patients taking Stalevo, a Parkinson's disease medication, may be at an increased risk for developing prostate cancer. In this trial, patients taking Stalevo were compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication also used to treat Parkinson's disease. At this time, FDA's review of Stalevo is ongoing and no new conclusions or recommendations about the use of this drug have been made... Patients should not stop taking their medication unless directed to do so by their healthcare professional. This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete. Additional Information for Patients FDA has not concluded that Stalevo increases the risk of developing prostate cancer. The Agency is still reviewing the available information on this safety concern. Do not stop your treatment with Stalevo or Comtan unless told to do so by your healthcare professional. Talk to your healthcare professional if you have concerns about Stalevo or Comtan. " Full text at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm206363.htm ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn