Signal detection of rhabdomyolysis and death for rivastigmine: a pharmacovigilance study

Abstract

The following study utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) database to determine the AChI inhibitor, rivastigmine’s effect on patient mortality as well as its side effect of rhabdomyolysis. The statistical analysis involved finding the number of cases of death/rhabdomyolysis for rivastigmine (using both the whole database and only the AChI class as comparators). The reporting odds ratios (ROR) was then calculated. In terms of patient mortality, the results showed that rivastigmine was significantly associated with more cases of deaths both when compared within the class (ROR = 10.62; CI 95% = 7.84 – 14.38; P < 0.0001) and also with the whole database (ROR = 5.90; CI 95% = 5.43 – 6.41; P < 0.0001). Additionally, no cases of reported rhabdomyolysis were found for rivastigmine. Hence, rivastigmine's apparent negative effect on patient mortality should be something to consider while selecting the drug for therapy.