Reports Of Heart Valve Damage In 2007 Gave Rise To Permax Recalls In U.S. And, Later, In Canada; What About Dostinex, Which Had Similar Reports?
(Posted by Tom Lamb at DrugInjuryWatch.com)
In January 2007 the New England Journal of Medicine (NEJM) reported on studies that showed Permax and Dostinex significantly increased the risk of developing heart-valve damage.
Several months afterwards, in March 2007, the FDA was able to get the drug company responsible for Permax to issue a voluntary recall of Permax, a Parkinson's disease drug.
Since then, with the drug being withdrawn in the U.S. and Canada, we have not heard much about Permax.
In June 2008, however, two new medical journal articles about Permax and and its connection to valvular heart disease were published.
One new article about Permax and valvular heart disease was published in the June 16, 2008 edition of the Journal of Neurology. It was written by several French doctors who wanted to further develop the association between Permax (pergolide) and heart-valve damage by conducting a case-control study intended to estimate the frequency and severity of Permax-induced valvular heart abnormality and the possible reversibility of that abnormality after the Permax was withdrawn.
We get these study results from an Abstract for this first June 2008 article, "Valvular heart disease in patients with Parkinson's disease treated with pergolide. Course following treatment modifications.":
RESULTS : Compared to controls, aortic regurgitation (OR: 3.1; 95 % IC: 1.1-8.8) and mitral regurgitation (OR: 10.7; 95 % IC: 2.1-53) were more frequent in PD patients (tricuspid: NS). The number of affected valves (n = 2.4 +/- 0.7) and the sum of regurgitation grades (n = 2.8 +/- 1.09) were higher (p = 0.008 and p = 0.006, respectively) in the pergolide group. Severity of regurgitation was not correlated with pergolide cumulative dose. A restrictive pattern of valvular regurgitation, suggestive of the role of pergolide, was observed in 12/30 (40 %) patients including two with heart failure. Pergolide was discontinued in 10 patients with valvular heart disease, resulting in a lower regurgitation grade (p = 0.01) at the second transthoracic echocardiography and the two patients with heart failure returned to nearly normal clinical examination. This study supports the high frequency of restrictive valve regurgitation in PD patients treated with pergolide and reveals that a significant improvement is usual when the treatment is converted to non-ergot dopamine agonists.
A second new Permax report, this one out of Australia, is about a woman who developed moderate to severe mitral and aortic valve insufficiency, which required semi-urgent double-valve replacement, after taking a low-dose of Permax for about five years.
The Abstract for this June 2008 article, "Valvular heart disease associated with taking low-dose pergolide for restless legs syndrome.", includes this remark:
Valvular heart disease is associated with the use of dopamine agonists for the treatment of Parkinson's disease and obesity, typically at much higher doses.
Meanwhile, Pfizer's Dostinex (cabergoline) remains on the market despite the January 2007 NEJM reports that Dostinex, like Permax, was linked to valvular heart disease.
We are interested in hearing about, or from, patients who developed any valvular heart abnormality while using Dostinex.