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Possible Stalevo Prostate Cancer Link Under Investigation

Mar 31, 2010 | Parker Waichman LLP

The Parkinson's disease drug Stalevo may be associated with a higher risk of prostate cancer.   The Food & Drug Administration (FDA) announced yesterday that it was conducting a safety review of Stalevo.

The FDA has advised that healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening. Patients should not stop taking their medication unless directed to do so by their healthcare professional, the agency said.

According to a an FDA Early Communication, data from a long-term clinical trial, known as STRIDE-PD, unexpectedly found that a greater number of patients taking Stalevo had prostate cancer compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication used to treat Parkinson’s disease.

Nine out of 245 males had prostate cancer in the Stalevo group compared to two out of 222 males in the carbidopa/levodopa group. The incidence rate of prostate cancer was 14 cases/1,000 patient years for Stalevo and 3.2 cases/1,000 patient years for carbidopa/levodopa.

The STRIDE-PD trial was a double blind, randomized, parallel group, controlled clinical trial conducted at 77 centers in 14 countries, including 31 sites in the United States, between September 2004 and November 2008. According to the FDA, 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.
The FDA said it is exploring additional ways to better understand if Stalevo actually increases the risk of prostate cancer. The agency pointed out that prostate cancer is most commonly diagnosed in men who are of the same age as men included in the STRIDE-PD trial. Previous controlled clinical trials of shorter duration evaluating Stalevo in Parkinson’s disease have not found an increased risk of prostate cancer.

Stalevo — which contains the active ingredients carbidopa, levodopa and entacapone — is marketed in the United States by Swiss-based Novartis and manufactured by Finnish drugmaker Orion.

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