Labeling change for Reminyl

In a measure negotiated with the U.S. Food and Drug Administration (FDA), Ortho-McNeil Neurologics, manufacturer of the Alzheimer drug galantamine (Reminyl), added a precaution to the package insert and sent a letter to physicians alerting them of the change. The added information reflects data from two clinical trials showing a larger number of deaths in participants receiving galantamine than in those receiving a placebo. The trials were testing galantamine's effectiveness for mild cognitive impairment (MCI), a condition in which individuals have memory problems greater than expected for their age and education but do not meet diagnostic criteria for dementia.

No previous studies have linked galantamine to an elevated death rate. The drug is currently FDA-approved for mild to moderate Alzheimer's disease and there are no plans to seek approval for MCI. In the MCI trials, there were unusually low numbers of deaths in both the galantamine treatment group and the placebo group. Deaths that occurred were due to various causes that would be expected in older adults, including heart attack, stroke and sudden death.

For more information, please see:

• FDA's announcement of the packaging change and physician letter:
  http://www.fda.gov/
  
  
• Ortho-McNeil's letter to physicians:
  http://www.fda.gov/
  
  
• Alzheimer's Association fact sheet on cholinesterase inhibitors, the class of Alzheimer drugs that includes galantamine (Reminyl), donepezil (Aricept) and rivastigmine (Exelon)
  http://www.alz.org/
  
  
• Alzheimer's Association Research News article from Jan. 24, 2005: "Regulators review safety data from Reminyl MCI trials"
  http://www.alz.org/