Reported Adverse Drug Reaction Cases
- ADRAC. Cholinesterase Inhibitors and Cardiac Arrhythmias. Australian Adverse Drug Reactions Bulletin, 2004; 23:5.
- http://www.clinicalstudyresults.org/drugdetails/? company_id=19&inn_name_id=66&indication_id=821&sort=c.company_name&page=1&drug_id=96
Deaths with galantamine in mild cognitive impairment studies
Galantamine (Reminyl), donepezil (Aricept) and rivastigmine (Exelon) are approved in Australia for the treatment of mild to moderately severe Alzheimer's dementia. Cardiac arrhythmias with these cholinesterase inhibitors were described in the October 2004 Bulletin.1
Galantamine has also been investigated in patients with mild cognitive impairment, an indication which is not approved in Australia. In two placebo controlled trials (total of 2048 subjects), there was a higher mortality with galantamine (n=13) than placebo (n=1, relative risk 6.19, 95% confidence interval 2.17, 17.68), and galantamine was not effective.2 The deaths were due to various causes which could be expected in an elderly population.
A description of the results of these studies has recently been added to the 'Precautions' section of the Australian Product Information for Reminyl, along with further advice to use with caution in patients with cardiovascular and pulmonary conditions, particularly immediately after myocardial infarction and with new onset atrial fibrillation, second or third degree heart block, unstable angina and pneumonia.
ADRAC advises that galantamine should only be used for the approved indication of mild to moderately severe Alzheimer's dementia. The safety and efficacy in other indications have not been established and the risks may outweigh the benefit.Reference
Australian Adverse Drug Reactions Bulletin
Volume 25, Number 1, February 2006