April 5, 2005 -- The deaths of 13 elderly patients taking the Alzheimer's drug Reminyl during a study has prompted a change to the drug's label.
News of the voluntary label change was announced in a "Dear Healthcare Professional" letter from Reminyl maker Ortho-McNeil, a subsidiary of Johnson & Johnson.
Information about the deaths will be added to the "Precautions" section of Reminyl's label. There is no change in the dosage of the drug or the indications for its use.
Reminyl is approved only for the treatment of mild-to-moderate Alzheimer's disease. The studies were exploring the use of the drug for mild cognitive impairment. Mild cognitive impairment is memory loss less severe than Alzheimer's disease but more severe than would be expected based on a person's age.
In the two studies, 1,026 patients received Reminyl and 1,022 patients received a placebo. There were 13 deaths in the Reminyl group but only one death in the placebo group.
It's not clear why there were more deaths in the Reminyl group. The letter notes that during the first six months of the two-year trials, there were no deaths in the placebo group -- "a highly unexpected finding in this population," the letter states.
Studies of patients with Alzheimer's disease do not show increased deaths among patients treated with Reminyl.
For more information about Reminyl, contact Ortho-McNeil Neurologics at (800) 526-7736.