Information for Healthcare Professionals: Galantamine hydrobromide (marketed as Razadyne, formerly Reminyl)
[For additional information about this drug, see Razadyne Information.]
To report any unexpected adverse or serious events associated with the use of Razadyne, please contact the FDA MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page.
Available information, including postmarketing data from the FDA’s Adverse Event Reporting system (AERS) database, does not warrant changing prescription recommendations at this time. We wish to emphasize the following:
- Razadyne is approved as a treatment for mild to moderate Alzheimer’s disease but not for mild cognitive impairment.
Two 2-year trials, involving 2,000 patients in 16 countries, studied whether Razadyne could slow progression to dementia in patients with mild cognitive impairment. Individuals with mild cognitive impairment demonstrate isolated memory impairment greater than expected for their age and education, but do not meet current diagnostic criteria for Alzheimer’s disease; however, the majority of individuals with mild cognitive impairment do appear to develop overt Alzheimer’s disease over time.
Follow-up information regarding deaths in these studies is available for about 88 percent of participants. Fifteen (1.5%) deaths in patients taking Razadyne and five (0.5%) deaths in patients taking placebo were reported during the double-blind portion of the two studies, either while taking study drug/placebo or within 30 days of study drug/placebo discontinuation. The causes of death in the 20 patients are similar to those commonly occurring in an older population, and were varied, with no single cause predominating.
Review of mortality and other safety data for these two trials is ongoing.
In a number of earlier clinical trials, none of which lasted longer than 6 months, in similarly-aged patients (including patients with Alzheimer’s Disease), the incidence of deaths in those treated with Razadyne was no higher than in patients treated with placebo, and the incidence of deaths in those treated with placebo was far higher than in the trials of mild cognitive impairment, described above.
Report serious adverse events to FDA's MedWatch either online, by regular mail or by fax, using the contact information at the bottom of this page.
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570