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Senior Citizen Alerts
Parkinson's Treatment Drugs Being Withdrawn, Says
FDA
Permax (pergolide) and two generic versions may
damage heart valves
 March 29, 2007 – Pergolide products used to treat
Parkinson's disease is being withdrawn from the market, according to an
announcement today from the U.S. Food and Drug Administration. The FDA
said 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 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The products being withdrawn are Permax, the trade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.
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