Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review:
Possible increased cardiovascular risk
Audience: Neurology, Cardiology
Issue: 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. 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.
Background: Both Stalevo and Sinemet have been shown to be effective
treatments for the symptoms of Parkinson's disease. The addition of entacapone
to carbidopa/levodopa has been shown to lead to a greater degree of
improvement in some of the symptoms of Parkinson's disease than treatment with
carbidopa/levodopa alone. Entacapone is also available as a single ingredient
product (sold under the brand name Comtan) to be always administered in
association with carbidopa/levodopa (entacapone has no antiparkinsonian effect
of its own). It is estimated that 154,000 patients were dispensed a
prescription for Stalevo from its approval in June 2003 through October 2009.
Recommendations: At this time, FDA's review of the potential
cardiovascular risk with Stalevo is ongoing. 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.
FDA is exploring additional ways to assess whether Stalevo increases the
risk of cardiovascular events, and will update the public when this review
is complete.
[08/20/2010 - _Drug Safety Communication_
(http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm) - FDA]
Related _MedWatch Safety Alert_
(http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm206934.htm) , March 2010
-
-
-
-
-
Roberta Innarella
----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:[log in to unmask]
In the body of the message put: signoff parkinsn
