Socié G, et al. - As eculizumab is the first and only medication approved for paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) treatment, researchers sought for its safety based on long-term pharmacovigilance. Via this analysis, they presented the largest safety data set to date, representing more than 10 years of post-marketing pharmacovigilance surveillance of eculizumab for the treatment of PNH and aHUS. They identified 76 cases of meningococcal infection (0·25/100 PY), including eight fatal PNH cases (0·03/100 PY). Among patients receiving eculizumab, susceptibility to meningococcal infections remained the key risk. The most common serious nonmeningococcal infections comprised pneumonia (11·8%); bacteraemia, sepsis and septic shock (11·1%); urinary tract infection (4·1%); staphylococcal infection (2·6%); and viral infection (2·5%). Eculizumab exposure was reported in 434 pregnant women; of 260 with known outcomes, 70% reported live births. Observations revealed stable reporting rates for solid tumors (≈0·6/100 PY) and hematological malignancies (≈0·74/100 PY) over time. In line with reports from clinical trials, this study supports the overall safety profile of eculizumab. These findings emphasize continued awareness and implementation of risk mitigation protocols to minimize the risk of meningococcal and other Neisseria infections in patients receiving eculizumab.