FDA MedWatch: Reminyl (galantamine) Precautions Due to Deaths Reported in Clinical Trials

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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

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