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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a prospective follow-up study of 180 pregnant woman registered in the French Reference Centre of Teratogenic Agents (CRAT) database, seven patients [including a 33-year-old woman, five neonates and one fetus; sexes and exact ages of six patients not stated] were described, out of whom the five neonates developed neonatal complications including polycythaemia, thrombocytopenia, acute fetal distress, hyaline membrane disease, icterus, hyponatraemia, enteropathy, hypotonia, apnoea, gastro-oesophageal reflux, anaemia or haemolytic anaemia following in-utero exposure to mycophenolate mofetil, rituximab, azathioprine, aspirin, cotrimoxazole, erythropoietin, sodium polystyrene sulfonate, lanthanum carbonate, methotrexate, mesalazine, heparin, retinol, unspecified steroids,...
- Sokal A, et al. Pregnancy and newborn outcomes after exposure to bisphosphonates: a case-control study. Osteoporosis International 30: 221-229, No. 1, 18 Jan 2019. Available from: URL: http://doi.org/10.1007/s00198-018-4672-9 - France