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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 36-year-old woman developed Fanconi syndrome (FS) and osteomalacia during treatment with adefovir for chronic hepatitis B [route not stated; time to reaction onset not clearly stated].
The woman presented to hospital with proteinuria and progressive multiple bone pain. She had been receiving lamivudine alongside adefovir 10mg daily for 7 years for chronic hepatitis B. Three years prior, she had undergone surgery for a non-traumatic right femur neck fracture. A technetium-99m bone scan was carried out for multiple bone pain and muscle weakness. Multiple hot bone uptakes were seen in both ribs, pelvis and right clavicle. Dual-energy X-ray absorptiometry demonstrated reduced bone mineral density of the lumbar spine. Upon admission, physical examination showed multiple bone...
- Park S, et al. Adefovir-induced Fanconi syndrome associated with osteomalacia. Clinical and Molecular Hepatology 24: 339-344, No. 3, 1 Sep 2017. Available from: URL: http://doi.org/10.3350/cmh.2017.0009 - South Korea