FDA Announces Ongoing Safety Review of Stalevo
 

I'm reposting this from the parkinsn list. Lots of questions -- few answers from the FDA. We should follow this one closely, and try to get some answers. For example, did they study posssible connection with other types of cancer? Should those at hgh risk switch from Stalevo back to sinemet and Comtan? Are they looking intoo possible cancer risks with Comtan itself???

FDA Drug Safety Communication: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer 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.

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 (see Data Summary below), and prostate cancer is most commonly diagnosed in men who are of the same age as men included in the STRIDE-PD trial.

see full text at

http://www.fda.gov/Drugs/DrugSafety/.../ucm206363.htm