Saturday, January 22, 2005

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.

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