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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 67-year-old man developed metastatic calcinosis cutis during treatment with dexamethasone for multiple sclerosis. Subsequently, he was successfully treated with denosumab.
The man, who had multiple sclerosis (MS), hypothyroidism and osteoporosis, presented with the complaint of left lower extremity cellulitis from several weeks, which was refractory to antibacterials. He complained of worsening left thigh pain progressively. Prior to this hospital admission, he was able to walk with a cane, and had an expanded disability status scale of 6. He had been receiving a long-term treatment with dexamethasone 1mg every 2 days [route not stated] for MS with various concomitant medications over six years for osteoporosis. He was alert and oriented except to time at presentation. A...
- Jorge A, et al. Metastatic calcinosis cutis due to refractory hypercalcaemia responsive to denosumab in a patient with multiple sclerosis. BMJ Case Reports 12: No. 2, 25 Feb 2019. Available from: URL: http://doi.org/10.1136/bcr-2017-223992 - USA