Stalevo® FDA Warning Lawyer

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The FDA cautions about heart risk linked to Parkinson’s drug Stalevo® with new warning

Stalevo Background

Stalevo, sold by Novartis, is a combination of three drugs: carbidopa, levodopa and entacapone. The combination of carbidopa and levodopa is sold separately under the brand name Sinemet and is a standard therapy for Parkinson’s, while entacapone is sold individually under the brand name Comtan. Comtan has no anti-Parkinson’s activity of its own, but it improves the efficacy of carbidopa/levodopa.

What’s the problem with Stalevo?

FDA notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet). FDA’s decision to conduct a meta-analysis was based on findings from the Stalevo Reduction In Dyskinesia Evaluation – Parkinson’s Disease or STRIDE-PD trial, which reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those receiving only carbidopa/levodopa.

Stalevo FDA Warning

In August 2010, the FDA cautioned that it is investigating the possibility that Stalevo may increase the risk of heart attack, stroke, and death in elderly patients who are taking it. FDA urged patients not to stop taking the drug, but warned them to let their physicians know if the patients have risk factors for cardiovascular disease.