by Playfuls Staff |
30th March 2007
FDA announced that manufacturers of pergolide drug products,
which are used to treat Parkinson’s disease, will voluntarily remove these
drugs from the market because of the risk of serious damage to [more] patients’
heart valves.
The products being withdrawn are Permax, the trade name for
pergolide marketed by Valeant Pharmaceuticals, and two generic versions of
pergolide manufactured by Par and Teva. Pergolide is in a class of medications
called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms
(tremors and slowness of movement) of Parkinson’s disease.
In 2006, an estimated 12,000 patients received prescriptions
for pergolide from retail pharmacies in the United States. Patients taking
pergolide should contact their doctors to discuss alternate treatments.
Patients should not stop taking the medication, as stopping pergolide abruptly
can be dangerous.
There are alternative therapies available for Parkinson’s
disease, including three other dopamine agonists that have not been associated
with valvular heart disease. The removal of pergolide products is not expected
to adversely affect patient care because of the alternative therapies
available.
“Based on important new drug safety information, FDA has
been working with the manufacturers of pergolide products to voluntarily remove
these drugs from the market,” said Douglas Throckmorton, M.D., deputy director
of FDA’s Center for Drug Evaluation and Research. “The FDA’s increased
evaluation of post-market safety is benefiting the public because, in this
case, as new data about the product became available, we were able to remove a
less safe drug from the market.”
Two recent New England Journal of Medicine studies confirm
previous findings associating pergolide with increased chance of regurgitation
(backflow of blood) of the mitral, tricuspid, and aortic valves of the heart.
Valve regurgitation is a condition in which valves don’t close tightly,
allowing blood to flow backward across the valve. Symptoms include shortness of
breath, fatigue and heart palpitations.
In light of this additional post-market safety information,
the companies that manufacture and sell pergolide will stop shipping pergolide
for distribution and, in cooperation with FDA, will withdraw the products from
the market.
Permax was approved in 1988 for Eli Lilly and Company as an
adjunctive therapy with levodopa in Parkinson’s disease. Valvular heart disease
was first described in association with pergolide in 2002. In 2003, FDA asked
Lilly to add valvulopathy (abnormality of cardiac valves) to the warnings
section of Permax labeling, at which time a Dear Healthcare Practitioner letter
was sent by Lilly. In 2006, the warning was upgraded to a black box warning,
the FDA’s strongest form of warning, because of new data concerning risks of
heart valve damage.
FDA today is issuing a Public Health Advisory (PHA)
detailing the removal of pergolide products from the market. The PHA, which is
available at www.fda.gov/cder/drug/advisory/pergolide.htm includes information
and recommended actions for physicians, pharmacists and patients.
The effect of the voluntary withdrawal on supplies of
pergolide currently in pharmacies will not be immediate. This delay will allow
time for health care providers and patients to discuss appropriate treatment
options and time to change treatments.
FDA is working with the manufacturers of pergolide to
determine if it might be possible, once the drug is withdrawn from the market,
to make the drug available under an Investigational New Drug Application (IND)
for those few patients who are currently receiving pergolide and who cannot be
successfully converted to other available treatments.
Source: FDA
