Pergolide (marketed as Permax)

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On March 29, 2007, the Food and Drug Administration issued a Public Health Advisory titled: Voluntary Market Withdrawal of Permax.

The drug is also known and marketed by its generic name pergolide [per-go-lide].

I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research.

We are notifying you that the companies that manufacture and distribute pergolide have agreed to withdraw this drug from the market due to the potential for heart valve damage.

Two new studies showed that patients with Parkinson's disease who were treated with pergolide had an increased chance of serious damage to their heart valves when compared to patients who did not receive the drug.

Pergolide is a member of a class of drugs known as dopamine [dough-pah-mean] agonists and is used with levodopa and carbidopa to manage the signs and symptoms of Parkinson's disease, which include tremors and slowness of movement.

If you are a patient with Parkinson's disease who is taking pergolide, you should take these two steps:

• First, contact your health-care professional to discuss alternate treatment options.

• Second, DO NOT STOP taking Pergolide without consulting your health-care professional. Stopping pergolide too quickly can be dangerous and several other effective treatments are available.

If you are a health-care professional who prescribes pergolide, you should consider the three following items:

• First, Assess your patient's need for dopamine-agonist therapy. If continued treatment with a dopamine-agonist is necessary, another dopamine-agonist should be substituted for pergolide. There are other dopamine agonists approved for the treatment of Parkinson's disease that are not associated with heart valve damage. Published transition regimens describe the conversion from one dopamine-agonist to another.

• Second, if treatment with a dopamine-agonist is to be discontinued, pergolide should not be stopped abruptly, because rapid discontinuation of all dopamine-agonist therapies can be dangerous. Instead, gradually decrease the dose of pergolide.

• Third, you should tell patients who will be taken off pergolide that other effective options for treatment exist, including three other dopamine agonists that are not associated with damage to heart valves.

In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the labeling for pergolide. The two recent studies, published in The New England Journal of Medicine in January 2007, confirm earlier studies that also described this problem.

Pergolide is marketed by Valeant under the trade name Permax and sold and manufactured as the generic drug pergolide by Par and Teva.

In light of this additional safety information and the availability of alternative treatments for Parkinson's disease that do not have comparable safety problems, the companies that manufacture and sell pergolide have stopped shipping pergolide for distribution.

The companies will, in cooperation with us, work to remove from the market both Permax and generic versions of pergolide.

The effect of this voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health-care professionals and patients to discuss appropriate treatment options and to change treatments.

One of the drugs that was included in the recent studies showing increased chance of heart valve problems is another dopamine agonist — Dostinex — also known by the generic name Cabergoline.

This drug is approved in the united states for the treatment of hyperprolactinemic [hyper-pro-lack-teh-knee-mick] disorders — conditions in which there are elevated levels of prolactin [pro-lack-tin] in the blood.

Dostinex is not approved in the United States for the treatment of Parkinson's disease. For hyperprolactinemic disorders, a considerably lower dose of Dostinex is used. At these lower doses of Dostinex, there appears to be little chance of heart problems; therefore, Dostinex will remain on the U.S. market for the treatment of hyperprolactinemic disorders.

We are working with the manufacturers of pergolide to determine if it is possible to make the drug available to those few patients who are currently taking pergolide under these two conditions:

• First, where previous efforts to switch to a different treatment have been unsuccessful.

• Or, second, where efforts subsequent to this advisory to switch therapies are also unsuccessful.

In the interim, health-care professionals and patients should consider all treatment options with the understanding that in the future, the drug may no longer be available.

We are asking health-care professionals to report serious adverse events in connection with pergolide to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot gov slash MedWatch.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot gov slash C-D-E-R.

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