April 2005
Two clinical trials have indicated that people taking the Alzheimer's disease drug Razadyne, previously known as Reminyl (galantamine) have a much higher death rate than those taking a placebo. The review was announced by Johnson & Johnson who manufacture Reminyl. Johnson and Johnson said that they were in discussions with the Food and Drug Administration and other regulators in Europe and Canada.
The two year drug trials looking at the efficacy of Razadyne involved over 2,000 people in 16 countries suffering from mild cognitive impairment. Razadyne currently approved in 69 countries as a treatment for mild to moderate Alzheimer's but not for mild cognitive impairment. 15 people taking part in the drug trials died from a number of conditions including heart attack and strokes compared with only 5 taking the placebo pills.
Razadyne is a is a cholinesterase inhibitor which increases the levels of a chemical called acetylcholine that transmits nerve signals in the brain.
Advice for those people currently taking Razadyne (galantamine)
The advice is to continue taking Razadyne if it has been prescribed for mild to moderate Alzheimer's disease. If you do have concerns then you must contact your doctor to discuss alternatives or discontinuation of the drug. Johnson and Johnson have said that overall the deaths of people on the trial were low for the elderly population and that the investigators did not believe the deaths were caused by Razadyne.
No previous studies have linked galantamine to an elevated death rate.
Company Response
As a result of discussion and negotiation with the Food and Drug Administration Ortho-McNeil Neurologics, manufacturer of the Alzheimer drug galantamine (Reminyl), have added a precaution to the package insert and have sent a letter to physicians alerting them of the change.
To view the letter sent by Ortho-McNeil Neurologics click here.
04/08/2005
