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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
* drug interaction
In a case series, three women aged 50−70 years were described, who developed osteonecrosis of jaw (ONJ) following concomitant administration of methotrexate and alendronic acid [alendronate; routes not stated; not all dosages stated].
Case 1: A 70-year-old woman had been receiving low dose methotrexate for rheumatoid arthritis and alendronic acid 70mg/week for osteoporosis. She had undergone dental extraction and was prescribed chlorhexidine mouth wash with unspecified antibiotics. However, after 5 months of dental extraction surgery, she presented with oral symptoms. An extra-oral examination showed tenderness on palpation and an intra-oral examination demonstrated a non-healing exposed bone at the extraction. On palpation, slight pus discharge was noted...