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FDA warns new Parkinson's drug may contribute to liver failure WASHINGTON (November 16, 1998 7:45 p.m. EST http://www.nandotimes.com) -- A new drug used to treat Parkinson's disease may cause fatal liver damage and should be reserved for severe cases where other therapies proved futile, the government warned on Monday. The Food and Drug Administration approved Hoffman-La Roche's Tasmar last January. But recently the agency learned of three deaths from severe liver damage, and on Monday ordered Roche to put the government's strongest warning on the drug's label. Don't stop taking Tasmar without first talking to your doctor, the FDA stressed to patients. Abruptly quitting the drug can lead to a rebound of Parkinson's symptoms or other side effects, so patients deemed too much at risk for the drug must be weaned off. It takes only three weeks' use of Tasmar to tell whether it is going to offer a significant benefit to a particular Parkinson's patient. So patients will know quickly whether Tasmar offers them enough help to justify the risk of possible liver damage, said FDA drug chief Dr. Murray Lumpkin. Anyone who takes Tasmar, known chemically as tolcapone, must undergo liver testing every two weeks and watch carefully for symptoms of liver failure, including jaundice, fatigue and loss of appetite, the FDA said. More than 1 million Americans have Parkinson's disease, a degenerative neurological disorder. Patients suffer progressive muscle rigidity, tremors and difficulty moving as brain cells that manufacture dopamine, a chemical important for movement, are destroyed. There is no cure for Parkinson's, but certain drugs can help control the symptoms. The cornerstone of treatment consists of the medicines levodopa and carbidopa, which increase the amount of dopamine available in the brain. But these drugs' impact gradually wane over time. Tasmar is supposed to be taken together with levodopa and carbidopa in people already using the highest doses of those two medicines. The combination slightly enhances the older drugs' effects, in clinical trials giving patients up to two more hours of easier movement each day. "This is for people who have reached the end of the rope," Lumpkin explained. About 60,000 people worldwide have taken Tasmar, including up to 30,000 Americans. While the FDA has learned of only three deaths so far -- a Californian, a Canadian and a Swiss -- the agency deemed the risk serious enough that Tasmar's drug labeling will include an "informed consent" document for patients to sign signifying they understand the possibility of the side effect. Roche sent letters to thousands of U.S. doctors Monday explaining the new warnings, but did not immediately say whether it would issue similar warnings in Canada and Europe. By LAURAN NEERGAARD, AP Medical Writer Copyright 1998 Nando Media Copyright 1998 The Associated Press janet paterson - 51/41/37 - almonte/ontario/canada http://www.newcountry.nu/pd/members/janet/ [log in to unmask]