Pergolide

[~MaryO~]

From http://www.thehorse.com/ViewArticle.aspx?ID=9317

 

Equine Cushing's Drug Pergolide to be Withdrawn for Human Use

by: Erin Ryder, News Editor

April 04 2007

Article # 9317

 

The FDA has announced pergolide is to be voluntarily withdrawn for human use. Pergolide is commonly used for horses with pituitary pars intermedia dysfunction (PPID), also known as equine Cushing's disease.

 

According to the FDA announcement, all pergolide products (Permax and two generic formulas) will be withdrawn for human use. Pergolide has been used as a treatment for Parkinson's disease. Concerns about the serious risk of damage to patients' heart valves led to the withdrawal.

 

Barbara D. Forney, MS, VMD, noted in the 2007 revised edition of Understanding Equine Medications that no information could be found on side effects of pergolide in horses.

 

Regarding the withdrawal, Forney said some other drugs removed from the human market in the past are now available for veterinary use via compounding pharmacies.

 

Forney said she doesn't anticipate a major change in the availability of the drug for equine use.

 

"The reality of it is that most of the horses that are on pergolide are already using a compounded product because of the way the drug is dosed and economics, so it probably won't change much," Forney stated. "But it does highlight why ethical compounding is really important to veterinarians."

 

FDA Department of Public Affairs spokesperson Sandy Walsh said the manufacturers could also make the drug directly available for veterinary use.

 

"Pergolide is not an approved animal drug," Walsh said. "As for deciding whether or not the product will be available for vet use, it depends on the company. If they want to make it available for animal use, that is their prerogative."

 

Walsh noted three other dopamine agonists without the same risk of side effects are available for human patients.

 

To read the FDA withdrawal notice click here or see below.

 

 

FOR IMMEDIATE RELEASE

P07-54

March 29, 2007

 

Media Inquiries:

Sandy Walsh, 301-827-6242

 

Consumer Inquiries:

888-INFO-FDA

 

FDA Announces Voluntary Withdrawal of Pergolide Products

Agency Working with Product Manufacturers

 

The U.S. Food and Drug Administration (FDA) today 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 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.