Hyponatraemia and unsteadiness in a 45-year-old man on carbamazepine
A pharmacovigilance case for causality assessment: work out which drug is responsible, grade the reaction's severity and seriousness, and defend a causality category using the WHO-UMC causality assessment.
WHO-UMC causality assessment
- Framework
- WHO-UMC causality assessment
- You decide
- Suspect drug, reaction, severity, seriousness, causality
The case
Mr A, a 45-year-old man, presented to the emergency department with a two-day history of nausea, generalised weakness, and unsteadiness when walking. He had been well until three weeks earlier, when he was started on carbamazepine 400 mg twice daily for trigeminal neuralgia. He had also been taking hydrochlorothiazide 25 mg once daily for hypertension for several years. He reported no vomiting, headaches, or seizures. On examination, he was apyrexial, blood pressure 128/78 mmHg, pulse 72 bpm, and oxygen saturation 96% on air. Neurological examination showed mild ataxia and subtle confusion, but no focal deficits. Laboratory results revealed a serum sodium of 124 mmol/L (reference range 135 to 145), potassium 4.1 mmol/L, creatinine 78 µmol/L, blood urea 5.2 mmol/L, serum osmolality 262 mOsm/kg, urine osmolality 520 mOsm/kg, and urine sodium 68 mmol/L. TSH and cortisol were within normal ranges. His medication history was otherwise unchanged. Carbamazepine was stopped, and he received careful sodium correction. Over the following 48 hours, his sodium rose to 131 mmol/L and his symptoms resolved completely. He remained on hydrochlorothiazide throughout. A rechallenge was not performed. The presentation was consistent with syndrome of inappropriate antidiuretic hormone secretion (SIADH).
What you are asked to do
- Identify which of the patient's drugs is the suspect, and say why the others are not.
- Name the reaction and grade its severity.
- Decide whether it is serious by regulatory criteria, which is not the same as severe.
- Assign a causality category under the WHO-UMC causality assessment and justify it from the timeline, the dechallenge and the alternative causes.
- State the management and what should be reported.
The suspect drug and the graded answer are deliberately not on this page: working them out is the exercise.
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A free account opens the trainer: name the suspect drug, grade the reaction and commit to a causality category, then see how your assessment compares and why.
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Educational content for students and clinicians in training. It does not replace professional judgement, local protocols or current prescribing information.