Data from two clinical trials indicated that people taking Reminyl (Generic: Galantamine) have a much higher death rate than those taking a placebo. Reminyl is an Alzheimer’s disease drug. The review was announced on 1/21/05 by Johnson & Johnson, which said it’s in discussions with the Food and Drug Administration and regulators in Europe and Canada.
The trials, involved approximately 2,000 patients in 16 countries. were looking if Reminyl could be used to treat mild cognitive impairment, a form of memory loss that is often associated with Alzheimer’s. Reminyl is approved in 69 countries as a treatment for mild to moderate Alzheimer’s but not for mild cognitive impairment. In the trials, which lasted two years, 15 patients taking Reminyl died compared with 5 taking the placebo.
The announcement comes at a time of heightened concern over the safety of widely used drugs after the withdrawal from the market of Merck’s pain reliever, Vioxx, which studies indicated posed an increased risk of heart attacks and strokes. Johnson & Johnson responded by saying that the overall number of deaths in the trials was low for the elderly population in the trial and that the incidence of serious side effects was the same for patients getting the drug and the placebo. Also, it said, the investigators in the trials had not thought the drug caused any of the deaths.
Reminyl was approved on the basis of six-month studies but the mild cognitive impairment trials lasted two years, increasing their chances of detecting side effects. Nevertheless, the Johnson & Johnson analysis said the excess of deaths in the mild cognitive impairment trials was evident by six months, while no such excess was seen in the Alzheimer’s trials.
Reminyl was developed with Shire Pharmaceuticals of Britain. Sales for Johnson & Johnson are estimated at about $200 million a year. Public Citizen, the watchdog group, recommends against using Reminyl or other drugs in its class, saying they have minimal benefit and the effectiveness and safety of taking them longer than six months is not known, according to Sidney Wolfe, director of health research.
Legal Help For Victims Affected By Reminyl
If you or a loved one took Reminyl and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).