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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 signal based analysis of patients derived from VigiBase (between 1 November 2000 and 2 May 2018) described 38 patients including 20 male and 17 female aged 5−60 years [age of one patient and sex of one patient not stated], of whom 37 patients developed jaw stiffness, trismus or tightness in jaw along with various other toxicities during treatment or following the withdrawal of methylphenidate and various other drugs. The remaining one patient developed hypertonia and trismus following the concurrent use of methylphenidate, omeprazole, paroxetine and ethinylestradiol [routes not stated; not all dosages, durations of treatments to reactions onsets and outcomes stated].
The patients received methylphenidate as mono-therapy or in combination with...
- Attalla M, et al. Methylphenidate and lockjaw WHO Pharmaceuticals Newsletter : 18-25, No. 4, 4 Sep 2019. Available from: URL: https://apps.who.int/iris/bitstream/handle/10665/326784/WPN-2019-04-eng.pdf?ua=1 - Sweden