US health officials withdrew the 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 (FDA) decided to pull the drug, first developed by Eli Lilly and Co. under the name Permax, after reports showed it can cause similar problems to the kind that triggered the withdrawal of the diet drug combination "fen-phen".
The risks, when added to the fact that it was no better than other available medications, showed "it really didn't have a place in therapy any more," said Robert Temple, head of the FDA's office of drug evaluation.
Pergolide is not widely used and sees between 12,000 and 25,000 prescriptions a year, Dr Temple said. Parkinson's patients taking the drug should not immediately stop taking it, but should be switched to alternative medicines, he added.
Lilly spokesman Charlie McAtee said the company transferred US ownership to Valeant Pharmaceuticals International in 2005. He added Lilly still sells the product under multiple names in other countries. Valeant representatives could not be immediately reached for comment. Both Par Pharmaceuticals and Teva Pharmaceutical Industries Ltd also make generic forms of the drug. All manufacturers of the drug agreed "the time had come" to halt sales, Dr Temple said.
Representatives of Par and Teva did not return calls seeking comment.
Pergolide, approved in late 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.
The FDA decided to pull the drug, which already carried a black box warning, after two reports published in January showed it could cause 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, Dr Temple said, the damage can require valve replacement surgery. If not fixed, the condition can cause heart failure and sudden death.
Pfizer Inc. also makes a dopamine agonist called Dostinex, or cabergoline, that 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 US market for the hormone and blood disorder known as hyperprolactinemia.
Higher doses needed to treat Parkinson's that would trigger the valve problems are not FDA-approved, Dr 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," Dr 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 two cents at $17.13 on the New York Stock Exchange on Thursday. 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. Shares in Lilly closed up 40 cents at $53.41 on the New York Stock Exchange.