Stalevo & cardiovascular warning!
 

Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk


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.
Read the complete MedWatch 2010 Safety summary, including links to the Drug Safety Communication with Data Summary and the previous related MedWatch alert from March 2010, at:
http://www.fda.gov/Safety/MedWatch/S.../ucm223423.htm

geez
 

i had to wean off - was going to pop one occasionally but it makes me too dyskinetic. peg, did you tell me it was stalevo that gave you back spasms? and this is what they are replacing the missing sinemet with? what can one say - afterawhile its more than just money - it's just flat out incompetence - does anyone know what they are doing? i quit comtan `10 years ago or whenever it came out b ecause of dyskinesia and still gave it another shot....what the heck? had hell but changed it to heck.

adding:

what wonderful news for the pwp who have sinemet shortages in their countries!

and adding from pipeline email:

http://www.lawyersandsettlements.com...pulsive-2.html

Couldn't get my neuro to listen...
 

Funniest thing is, right before I titrated off the stuff, I had this weird feeling I was going to die soon from heart disease. I suppose it was when I realized I had outlived my mother, who died at 63 of heart disease, AND my father, who died at 44 of heart disease. Most docs will start listening to that kind of family history. Not the neurologist I was seeing at the time, who also ignored an increased frequency of falling.

I have about $500 worth of Stalevo, unused. I'm taking it back to the pharmacy today to be destroyed.

Jaye

Thank you for posting this, being in the UK I would not have known otherwise. I have irregular heart beat that never shows up when I am checked out, but is there when I wear off, and in the mornings as my first meds kick in. Also fluctuating blood pressure that goes quite high and settles back down. Previously I had low blood pressure and no awful irregular heart beat. I shall try and get it checked out, it has all been post entacapone, not stalevo, but they are the same thing right? Nobody EVER does any checks on what the meds are doing. no bloods, nothing.........

I too have been fearing something, but as it doesn't show up when checked I have not known what to do, medics and nurses all seem indifferent anyway....

Lindy

A couple of points!
 

Please note: Stalevo is a combination drug of carbidopa/Levodopa (Sinemet) and Entacapone (Comtan). I knew that sudden withdrawal of Sinemet or Comtan were highly dangerous.

Some of you indicated you were going to stop Stalevo, but this is not recommendned without careful watch by a professional. From the site www.rxlist.com :

Sporadic cases of a symptom complex resembling NMS have been reported in association with dose reductions or withdrawal of therapy with carbidopa-levodopa. Therefore, patients should be observed carefully when the dosage of Stalevo® is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serummyoglobin have been reported.

I imagine that replacing the Sinemet part of Stalevo would lesson the chances of this condition, but when I checked on the problems associated with stopping Comtan, I got this (from the same rxlist website):

Prescribers should exercise caution when discontinuing entacapone treatment. When considered necessary, withdrawal should proceed slowly. If a decision is made to discontinue treatment with Comtan, recommendations include monitoring the patient closely and adjusting other dopaminergic treatments as needed. This syndrome should be considered in the differential diagnosis for any patient who develops a high fever or severe rigidity. Tapering Comtan has not been systematically evaluated.

Bottom line, DO NOT STOP EITHER L-DOPA - COMTAN OR STALEVO WITHOUT BEING UNDER THE MANAGEMENT OF A DOCTOR!

And I think I now know why my dyskinesia has been worse - Comtan! (or Stalevo)

Peg