Two Chinese teams looked at the real-life side-effects of eculizumab in the treatment of myasthenia and alglucosidase alfa in the treatment of Pompe disease. Analysis of data from the FDA’s pharmacovigilance system, FAERS (FDA Adverse Event Reporting System), revealed :
- 46,316 side-effect reports for eculizumab between 2007 and 2023, grouped under 461 preferred terms;
- 4,326 side effects reported for alglucosidase alfa between 2006 and 2023, grouped under 359 preferred terms.
While most of the side effects reported were mentioned in the drug specifications, others such as chronic multifocal osteomyelitis for alglucosidase alpha or aplastic anaemia, mastication disorders, renal fibrosis, Koch’s bacillus infection, abnormal neutrophil count, C3 glomerulopathy, neuroblastoma or membrano-proliferative glomerulonephritis for eculizumab, were not reported in the package leaflets for these drugs.
