USA. The prescribing information for galantamine (Reminyl) has been updated to reflect the results of two randomised placebo-controlled clinical trials in which 13 of 1026 patients with mild cognitive impairment receiving galantamine (Reminyl) died, compared with 1 of 1022 patients who received placebo. Ortho-McNeil Neurologics Inc. has issued a 'Dear Health-care Professional' letter to advise that the results of these trials have been added to the Precautions section of the Reminyl Prescribing Information. In this letter, Ortho-McNeil Neurologics Inc. notes that galantamine (Reminyl) is approved only for the treatment of mild to moderate Alzheimer's disease.
'Dear Health-care Professional' letter from Ortho-McNeil Neurologics Inc., 31 March 2005 (http://www.fda.gov).