Signal detection of Rhabdomyolysis and death for galantamine: a pharmacovigilance study

Abstract

Galantamine is one of the common acetylcholinesterase inhibitors used to treat Alzheimer's disease, a neurodegenerative disorder. This study was conducted to determine the impact of galantamine on mortality rate and rhabdomyolysis using the FDA Event Reporting System(FAERS) database, which includes data from drug class and the whole database. Comparing the mortality rate of galantamine to that of other drugs and other class, it was found that 24 deaths were recorded on FAERS, compared to 456,120 and 680 deaths for other drugs and drug class, respectively. In this analysis, galantamine showed better mortality benefit than others. The ROR value of death cases for other drugs was 1.22(95%CI:0.81-1.83;p=0.3435) vs. drug class 0.31(95%CI:0.21-0.47;p<0.0001). Furthermore,8 rhabdomyolysis cases were recorded in FAERS, while 16379 and 19 cases were reported on other drugs and other class, respectively. It has been found that galantamine is more likely of causing rhabdomyolysis than other drugs. The Reporting Odds Ratio (ROR) value for rhabdomyolysis for other drugs was 11.35 (95%CI:5.65-22.80; p<0.0001) vs drug class 4.05(95%CI:1.77-9.29; p=0.0009).