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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
A 69-year-old woman experienced myoclonic jerks and inattentiveness following concomitant administration of arsenic trioxide with amitriptyline and duloxetine. Additionally, myoclonic jerks and inattentiveness were also attributed to pregabalin and cefepime [routes not stated; not all indications and dosages stated].
The woman, who had underlying hypertension, hypothyroidism, migraines and fibromyalgia, presented to an outside hospital with a 2-month history of fatigue and easy bruising along with watery diarrhoea. Review of systems showed mild gingival bleeding, weight loss over 5 months. Evaluation was also notable for pancytopenia with 32.0% promyelocytes. Following bone marrow biopsy findings, she was diagnosed with acute promyelocytic leukaemia (APL). She...
- Rhee JY, et al. Myoclonic jerks complicating treatment of acute promyelocytic leukemia: Case report and literature review. Blood Advances 3: 1854-1857, No. 12, Jan 2019. Available from: URL: http://doi.org/10.1182/bloodadvances.2019000249 - USA