Corrects second, ninth and last paragraphs of original story to reflect that Eli Lilly does not sell Permax. The drug is sold by Valeant Pharmaceuticals, but was developed by Eli Lilly. (Adds details, byline, background)

By Susan Heavey

WASHINGTON, March 29 (Reuters) - U.S. health officials withdrew Parkinson's disease drug pergolide from the market on Thursday, citing a history of safety concerns that include potentially fatal heart valve damage.

The Food and Drug Administration decided to pull pergolide, which is sold by generic drug companies and by Valeant Pharmaceuticals International <VRX.N> under the name Permax, after reports showed it can cause problems similar to those that triggered the withdrawal of diet drug combination "fen-phen."

The drug was originally developed by Eli Lilly & Co. <LLY.N>.

Pergolide is not widely used, with between 12,000 and 25,000 prescriptions a year, said Dr. Robert Temple, head of FDA's office of drug evaluation. Parkinson's patients already taking the drug should not immediately stop taking it but should be switched to alternative medicines, he added.

The risks, when added to the fact that the drug is no better than other available medications, showed "it really didn't have a place in therapy any more," Temple said.

All manufacturers of the drug agreed "the time had come" to halt sales, he said. Both Par Pharmaceuticals and Teva Pharmaceutical Industries Ltd. make generic forms of the drug.

Pergolide, approved as Permax in 1988, is a dopamine agonist usually used in combination with other medicines to help manage symptoms of Parkinson's -- a movement disorder with no cure that causes uncontrollable tremors throughout the body.

VALVE PROBLEMS

The FDA decided to pull the drug, which already carried a black box warning, after two reports published in January showed it could cause heart valve regurgitation. In such cases, the valves do not close tightly and the backflow of blood can lead to breathing problems, fatigue and heart palpitations.

While there were no reported deaths, Temple said, the damage can require valve replacement surgery. If not fixed, the condition can cause heart failure and sudden death.

Representatives for Valeant Pharmaceuticals, Par and Teva could not immediately be reached for comment.

Pfizer Inc. also makes a dopamine agonist called Dostinex, or cabergoline, which was cited for heart damage in the studies published by the New England Journal of Medicine.

While Dostinex is cleared for Parkinson's in Europe, it is only allowed on the U.S. market for treatment of the hormone and blood disorder known as hyperprolactinemia.

The FDA did not approve the higher doses needed to treat Parkinson's that would trigger the valve problems, Temple said.

Other similar drugs can cause problems but none as severe as heart damage, he said.

"We now have very good data that the other drugs with similar properties, other dopamine agonists, don't do this," Temple said. "We didn't really have that before."

Other dopamine agonists include GlaxoSmithKline's Requip, or ropinirole and Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex, or pramipexole.

Shares of Valeant closed up 2 cents at $17.13 on the New York Stock Exchange. Shares of Par closed up 63 cents at $25.24, also on the NYSE, while Teva shares closed up 16 cents at $36.85 on the Nasdaq.

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