Lip and tongue swelling in a 60-year-old man
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 60-year-old man, presented to the emergency department with a two-hour history of lip and tongue swelling. He had been well until that morning, when he noticed his lips feeling numb, followed by progressive swelling. Over the next hour, his tongue became enlarged, making speech difficult and swallowing uncomfortable. There was no rash, wheeze, or throat tightness. He had not experienced such symptoms before.
His past medical history included hypertension and type 2 diabetes mellitus. His regular medications were metformin 500 mg twice daily for two years, amlodipine 10 mg once daily for six months, and ramipril 5 mg once daily, which had been started exactly three weeks ago. He also mentioned taking an over-the-counter herbal supplement (Ginkgo biloba) for joint stiffness, which he had started two weeks previously and had taken once daily since then, including that morning.
On examination, his blood pressure was 150/90 mmHg, pulse 88 beats per minute, respiratory rate 16 per minute, and oxygen saturation 97% on room air. There was visible swelling of the upper and lower lips and an enlarged, oedematous tongue. The posterior pharynx and uvula were not swollen, and there was no stridor or respiratory distress. The remainder of the examination was unremarkable.
He was treated with intravenous chlorphenamine and hydrocortisone. Ramipril and the herbal supplement were withheld. Over the next 24 hours, the swelling gradually subsided completely, and his speech and swallowing returned to normal. He was observed in the emergency department for 12 hours and then admitted to the medical ward for further monitoring. The metformin and amlodipine were continued. A careful history revealed no new foods, insect stings, or other exposures on the day of the reaction. He had no known allergies to drugs or foods. A rechallenge with ramipril was not performed, as it was considered unsafe. The herbal supplement was also not restarted. He was discharged after 24 hours with a plan to review his antihypertensive regimen in the outpatient clinic.
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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Educational content for students and clinicians in training. It does not replace professional judgement, local protocols or current prescribing information.