Neuroscience
Safety Concerns Reported on J.& J. Alzheimer's Drug
By ANDREW POLLACK
New York Times
Published: January 22, 2005
Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated that people taking the drug had a much higher death rate than those taking a placebo.
The review was announced yesterday by Johnson & Johnson, which said it was in discussions with the Food and Drug Administration and regulators in Europe and Canada.
The trials, which involved about 2,000 patients in 16 countries, were looking at whether Reminyl could be used to treat mild cognitive impairment, a form of memory loss that is often a precursor to Alzheimer's disease. 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. There were various causes of death but many were from heart attacks and strokes, a company spokeswoman, Carol Goodrich, said.
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Neuroscience
Reminyl (galantamine hydrobromide) (continued)
Safety Concerns Reported on J.& J. Alzheimer's Drug
By ANDREW POLLACK
New York Times
Published: January 22, 2005
Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated that people taking the drug had a much higher death rate than those taking a placebo.
The review was announced yesterday by Johnson & Johnson, which said it was in discussions with the Food and Drug Administration and regulators in Europe and Canada.
The trials, which involved about 2,000 patients in 16 countries, were looking at whether Reminyl could be used to treat mild cognitive impairment, a form of memory loss that is often a precursor to Alzheimer's disease. 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. There were various causes of death but many were from heart attacks and strokes, a company spokeswoman, Carol Goodrich, said.
[ ... Read the full article ... ] (free registration required)
- Alzheimer's Disease: Gammagard Fails
From the company press release: Baxter Announces Topline Results of Phase III Study of Immunoglobulin for Alzheimer's Disease DEERFIELD, Ill., May 7, 2013 - Baxter International Inc. (NYSE:BAX) today announced that its Phase III clinical study of...
- Fda: Alzheimer Disease, Aricept (donepezil Hydrochloride)
From the FDA last week: FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease FOR IMMEDIATE RELEASE P06-168 October 13, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA...
- Abstract Of The Day: Alzheimer Disease Drug Treatments
Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25; (1): CD005593. BACKGROUND: Since the introduction of the first cholinesterase inhibitor (ChEI) in 1997, most clinicians and probably most patients...
- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...
- Issues In Clinical Trials: Gdnf And Parkinson Disease
Today's New York Times includes a front-page article about the culture of clinical-trials research: what happens to participant subjects when an experimental drug is pulled from testing and, among other issues, how teasing apart placebo-based from...