Permax (Generic: Pergolide mesylate) has been linked to serious heart
damage. Cardiac valvulopathy involving one or more valves has resulted
in some patients taking Permax. Permax is used to treat Parkinson's
Disease.
Dostinex (Generic:cabergoline 0.05 mg) has been linked to serious
heart damage. Cardiac valvulopathy involving one or more valves has
resulted from some patients taking Dostinex. Dostinex is used to treat
certain hormone problems (excess prolactin). The drug is also used to
reduce or prevent breast milk production, except after childbirth
(postpartum). The drug is also used for "restless leg syndrome." This
drug may also be used for Parkinson's disease, prolactin-producing
tumors and to adjust various hormone levels in certain diseases (ovarian
diseases).
The risk of heart valve damage with these two drugs for may be far
greater than was known, new research suggests.
Two studies were reported January 4th 2006 in the New England Journal Of
Medicine. One study, by Italian researchers, found that roughly
one-fourth of Parkinson's patients taking pergolide or cabergoline, sold
as Permax, Dostinex and other brands, had moderate to severe heart valve
problems. A second study, by German doctors, found that users of either
drug were five to seven times more likely to have leaky heart valves
than those on other types of Parkinson's medications.
Dr. Brian Roth, Professor of Pharmacology and Medical chemistry of the
University of North Carolina at Chapel Hill noted "these two studies
reinforce the notion of a causal connection between 5-HT2B {Pergolide
mesylate and cabergoline} and valvular heart disease.
"It's a bad side effect. As far as I know, there are no medications that
can reverse it," and valve replacement surgery is the only solution, he
said.
Roth had no role in the studies but directs a drug screening program for
the National Institute of Mental Health. He also published a paper
several years ago warning that these drugs appeared to trigger the same
heart-related mechanism that the fen-phen diet combination did. The diet
pills, sold as Pondimin and Redux, were pulled from the market in 1997
after they were linked to valve problems.
In one study, Dr. Renzo Zanettini and others at the Instituti Clinici di
Perfezionamento in Milan obtained echocardiogram images of the hearts of
155 patients taking various Parkinson's medications and a comparison
group of 90 healthy people. Moderate to severe valve problems were seen
in 23 percent of those on pergolide and nearly 29 percent of those on
cabergoline but none of those on other Parkinson's drugs and less than 6
percent of the comparison group. The study was paid for by the Milan
clinic and two Parkinson's foundations.
In the other study, Dr. Rene Schade and colleagues in Berlin and in
Montreal used records from more than 11,400 Parkinson's patients in the
United Kingdom. The rate of newly diagnosed leaky valves was increased
among pergolide and cabergoline users but not the others, they found.
The rights to Permax in the U.S. now belong to Valeant Pharmaceuticals
of Aliso Viejo, Calif. A company statement said Permax is safe and
effective, but Valeant is no longer promoting the product. All such
drugs should be used "with caution," the statement says.
Cabergoline is approved in the U.S. for treating a hormone problem,
excessive prolactin in the blood, but not Parkinson's.
Parkinson's disease is a progressive neurological disorder resulting
from the degeneration of neurons in a region of the brain that controls
movement. The degeneration creates a shortage of the brain-signaling
chemical known as dopamine, causing the movement impairments that
characterize the disease. In the United States, at least 500,000 people
are believed to suffer from Parkinson's disease, and about 50,000 new
cases are reported annually, according to the National Institute of
Neurological Disorders and Stroke.
If you are taking PERMAX or DOSTINEX and have had a heart attack or if a loved one has died while taking PERMAX or DOSTINEX contact
The Law Firm of Allen L. Rothenberg at
1-800-624-8888 or 1-800-ROTHENBERG.
|