FDA MedWatch: Reminyl (galantamine) precautions due to deaths re ported in clinical t

[Brian, ASN, RN]

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Ortho-McNeil Neurologics modified the PRECAUTIONS section of the Prescribing

Information for Reminyl, approved only for the treatment of mild to moderate

Alzheimer's Disease. The changes provide new safety information regarding

the results of two randomized, placebo-controlled trials of 2 years duration

in subjects with mild cognitive impairment(MCI). A total of 13 subjects on

REMINYL (n=1026) and 1 subject on placebo (n=1022) died. The deaths were due

to various causes which could be expected in an elderly population. About

half of the REMINYL deaths appeared to result from various vascular causes

(myocardial infarction, stroke), and sudden death.

Read the complete MedWatch 2005 Safety summary, including a link to the Dear

Healthcare Professional letter at:

www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Reminyl

[Nurse Ratched, RN]

Wow - how in the world would you separate out the deaths that occured by virtue of the fact that you are dealing with an elderly population, versus those r/t the med?

It's kinda like the problems with antidepressants being associated with a population that tends to commit suicide.