Neurologist

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Drug Information Update – Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.


 

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.

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.

The data being reviewed are from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation – Parkinson’s Disease (STRIDE-PD). STRIDE-PD evaluated the time to onset of dyskinesia (difficulty controlling voluntary movement) in patients with Parkinson’s disease taking Stalevo compared to those taking only carbidopa/levodopa. An unexpected finding in the trial was that a greater number of patients taking Stalevo were observed to have prostate cancer compared to those taking carbidopa/levodopa.

The agency is exploring additional ways to better understand if Stalevo actually increases the risk of prostate cancer. Previous controlled clinical trials of shorter duration evaluating Stalevo in Parkinson’s disease have not found an increased risk of prostate cancer, and prostate cancer is most commonly diagnosed in men who are of the same age as men included in the STRIDE-PD trial.

For more information, please visit: Stalevo 

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April 22, 2010 - Posted by | 1

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