by Archana Subramaniam by CNB
Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: FRIDAY, March 19, 1993 TAG: 9303190089 SECTION: NATL/INTL PAGE: A-2 EDITION: METRO SOURCE: Los Angeles Times DATELINE: LENGTH: Short
ALZHEIMER'S DRUG WINS 1ST OK TO BE MARKETED
A Food and Drug Administration advisory board unanimously recommended marketing approval Thursday for tacrine, the first drug approved for Alzheimer's disease, which affects as many as 4 million Americans.Approval of the drug requires action by the FDA itself, but the agency normally follows the recommendations of its advisory panels. The drug may be available to patients within a couple of weeks, and certainly within two or three months, said officials of the FDA and Warner-Lambert Co., which manufactures tacrine.
Although previous trials of the drug had proved inconclusive and the board had twice turned down marketing requests, new data indicated the drug can partially reverse the loss of mental function associated with the disease.
The panel noted that the drug does not work for everyone who takes it and it has the potential to cause severe side effects. One out of four patients who take the drug are susceptible to severe liver damage, but that damage is reversible if they stop taking the medication.