Restlessness, tremor and jaw stiffness in a 24-year-old woman given metoclopramide for vomiting in pregnancy
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 Naranjo probability scale.
Naranjo probability scale
- Framework
- Naranjo probability scale
- You decide
- Suspect drug, reaction, severity, seriousness, causality
The case
Mrs A, a 24-year-old primigravida at 12 weeks' gestation, presented to the emergency department with a two-day history of persistent vomiting and an inability to tolerate oral intake. She was diagnosed with hyperemesis gravidarum and admitted for intravenous fluid resuscitation and antiemetic therapy.
On admission (Day 1), she was started on:
- Ondansetron 4 mg orally twice daily.
- Metoclopramide 10 mg intravenously three times daily.
Her condition improved, and she tolerated clear fluids. On Day 3, approximately 30 minutes after receiving the second morning dose of metoclopramide, she developed a sudden onset of restlessness, an inability to sit still, a fine tremor of her hands, and stiffness of her jaw. She described a feeling of inner anxiety and an urge to move.
On examination, her heart rate was 110 beats per minute, blood pressure 120/70 mmHg, respiratory rate 18 per minute, and temperature 36.8°C. Neurological examination revealed cogwheel rigidity in the upper limbs, a fine postural tremor, and trismus. There were no focal neurological deficits, and withdrawal or foetal distress was not evident.
Investigations showed normal serum electrolytes, calcium, magnesium, glucose, and thyroid function tests. ECG showed a sinus tachycardia. Urinalysis was unremarkable.
Metoclopramide was stopped immediately. Ondansetron was continued. Over the next 24 hours, her symptoms gradually resolved completely, and she felt well. No rechallenge with metoclopramide was attempted.
An alternative explanation of anxiety was considered, but the objective findings of tremor and jaw stiffness, together with the normal investigations, made this unlikely. Ondansetron was also considered but is a less likely cause given its low propensity for extrapyramidal reactions at the administered dose.
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 Naranjo probability scale 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.