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FDA Conducting Safety Review of Parkinson’s Disease Drug

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Stalevo, a drug used to treat Parkinson’s disease, is undergoing as a safety review because of concerns that it could put patients at a higher risk of cardiac problems than another drug called Sinemet.

It’s important to note that the US Food & Drug Administration (FDA) has not yet concluded that Stalevo increases the risk of heart attack, strokes, or cardiovascular death. The agency said healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease. Patients should not stop taking Stalevo unless told to do so by their healthcare professional.

The FDA decided to conduct a safety review after a meta-analysis called the Stalevo Reduction In Dyskinesia Evaluation – Parkinson’s Disease, or STRIDE-PD, found a small increased risk of cardiovascular events in subjects taking Stalevo, according to the FDA. Based on those findings, the FDA conducted a meta-analysis that combined the cardiovascular findings from 15 clinical trials in approximately 4,800 patients, which pointed to the increased risk.

The FDA said it is exploring additional ways to assess whether Stalevo increases the risk of cardiovascular events, and will update the public when its review is complete.

Stalevo is a combination of carbidopa/levodopa and entacapone, while Sinemet contains only carbidopa/levodopa. Entacapone is also available as a single ingredient product (sold under the brand name Comtan) to be always administered in association with carbidopa/levodopa.

According to the FDA, it is estimated that 154,000 patients received prescription for Stalevo from its approval in June 2003 through October 2009.

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