The FDA has notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo® may be at an increased risk for cardiovascular events including heart attack, stroke, and cardiovascular death

What is Stalevo?

Stalevo is a medication often prescribed to treat Parkinson’s disease. The main component (levodopa) is used for treating symptoms of Parkinson’s, while the other two components of the drug (carbidopa and entacapone) help levodopa work better and longer. The drug is available by prescription only and comes in tablet form.

Stalevo Side Effects

Stalevo side effects include (but are not limited to):

• Severe allergic reactions (rash or hives)
• Difficulty breathing
• Swelling (mouth, lips, or tongue)
• Chest pain
• Confusion
• Dark urine
• Depression with thoughts of suicide
• Fainting
• Fever
• Hallucinations
• Increased or irregular heart beat
• Lack of response to environment
• Mental or mood changes
• Muscle pain, stiffness, or rigidity
• Paranoia
• Seizures
• Severe or persistent diarrhea
• Severe or persistent dizziness
• Stomach pain
• Trouble sleeping
• Unusual or painful movements of the face, eyelids, mouth, tongue, or limbs
• Unusual skin growths (mutation or color change of a mole)
• Unusual sweating
• Vomiting
• Yellowing of the skin or eyes

Stalevo FDA Report

Following the findings of a STRIDE-PD trial of Stalevo, the FDA reported that the drug may put patients at a higher risk of cardiovascular diseases.

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 an increased risk of cardiovascular events in subjects taking Stalevo, according to the FDA. STRIDE-PD combined the cardiovascular-related findings from 15 clinical trials comparing Stalevo to carbidopa/levodopa.

Based on those findings, the FDA conducted a meta-analysis that combined the cardiovascular findings from 15 clinical trials in approximately 4,800 patients comparing entacapone/carbidopa/levodopa to carbidopa/levodopa without entacapone. A composite endpoint of myocardial infarction, stroke, and cardiovascular death was used to represent cardiovascular events. Twenty-seven cardiovascular events were reported in the entacapone/carbidopa/levodopa group compared to 10 in the carbidopa/levodopa group. This resulted in a relative risk of 2.46.