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No Proof of Heart Risks from Parkinson’s drug

FDA finds no evidence of cardiovascular risks related to Novartis’ Stalevo

The FDA said Monday that there was no evidence of increased cardiovascular risks related to the use of carbidopa/levodopa/entacapone (Stalevo, Novartis) for Parkinson’s disease.

According to Reuters, recommendations for using the drug, which won U.S. approval in 2003, will remain the same on the labels after the FDA examined data from a required clinical trial and one additional study.  The review found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease.

A safety alert from the FDA warned patients and health care professionals about a possible increased risk for cardiovascular events and death with Stalevo in August 2010. This possible safety issue was observed in a clinical trial called the Stalevo Reduction in Dyskinesia Evaluation in Parkinson’s Disease (STRIDE-PD) and in a meta-analysis that combined the cardiovascular-related findings from 15 clinical trials comparing Stalevo to carbidopa/levodopa.

Carbidopa and levodopa have been used extensively and have not been shown to have an increased cardiovascular risk. The FDA was concerned that the entacapone in Stalevo was responsible for these cardiovascular risks because the comparison drugs do not contain this ingredient.

Source: FDA, October 26, 2015; Reuters, October 27, 2015.

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