US FDA questions safety of Novartis/Orion's Stalevo due to possible increased cardiovascular risk

The US Food and Drug Administration on Friday posted a web site notice stating that Swiss pharma major Novartis (NOVN.VX, NVS) and Finland-based Orion's (ORNBV.HE) Stalevo (a combination of carbidopa/levodopa and entacapone), indicated for the treatment of Parkinson's disease, may be associated with an increase - albeit small - in the risk of heart attack, stroke or death.

The FDA notified health care professionals that it is evaluating clinical trial data that suggest patients taking Stalevo may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the now off-patent combination product, Sinemet, originally market by DuPont Pharma, which Bristol-Myers Squibb acquired in 2001).

The agency'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. Although myocardial infarction, cardiac irregularities, hypertension and palpitations have been reported with levodopa, previous clinical trials with Stalevo did not show an imbalance in myocardial infarction, stroke, and cardiovascular death.