04/05/2005

Ortho-McNeil has revised the product labeling to include a warning about a possible increase in mortality with off-label use. Significantly more deaths occurred with galantamine (1.3%, 13/1026) than placebo (0.1%, 1/1022) in two trials in patients with mild cognitive impairment. This conflicts with trials in patients with Alzheimer’s Disease or dementia, which found a numerically higher mortality rate with placebo than galantamine. Galantamine is labeled for use in mild to moderate Alzheimer’s Disease. More details are available at the following links:

• FDA MedWatch Alert: www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Reminyl
• Dear Healthcare Professional Letter: www.fda.gov/medwatch/SAFETY/2005/reminylDDLmarch.pdf
• Revised Product Labeling: www.us.reminyl.com/active/janus/en_US/assets/rem/reminyl.pdf