(2005; 12 pages)
GALANTAMINE - Ineffective and possibly unsafe in mild cognitive impairment
Canada. Janssen-Ortho Inc., under advice from Health Canada, is warning health professionals that according to preliminary data from two investigational studies, galantamine (Reminyl), a cholinesterase inhibitor, does not appear to be effective in treating patients with mild cognitive impairment (MCI). In addition, the initial analysis of both studies showed that 15 patients died in the galantamine (Reminyl) treatment group and five in the placebo treated group. The causes of death were mainly cardiovascular or cerebrovascular in nature.
Janssen-Ortho is reminding that galantamine (Reminyl) is approved only for the symptomatic treatment of patients with mild to moderate dementia of the Alzheimer's type and that it is not to be used outside of its approved indication.
'Dear Health-care Professional' letter from Janssen-Ortho Inc., 21 January 2005. Available on the Internet at www.hc-sc.gc.ca