Adverse Drug Reaction Trainer

Haematemesis in a 68-year-old on ibuprofen and low-dose aspirin

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

A 68-year-old woman presented to the emergency department with a two-hour history of vomiting blood and passing black stools. She reported epigastric pain for the past six weeks, for which she had been taking over-the-counter ibuprofen 400 mg three times daily, started six weeks ago. She had been taking low-dose aspirin 75 mg once daily for the past five years for secondary prevention of stroke. She had no prior history of gastrointestinal bleeding or peptic ulcer disease. She did not smoke and drank minimal alcohol. On examination, she was pale, tachycardic at 110 beats per minute, blood pressure 90/60 mmHg, and had epigastric tenderness. Laboratory tests showed haemoglobin 72 g/L, platelet count 230 x10^9/L, creatinine 110 µmol/L, urea 15 mmol/L. Upper gastrointestinal endoscopy revealed a 1 cm gastric ulcer with a visible vessel and recent bleeding, but no active oozing at the time of the procedure. She was resuscitated with intravenous fluids and blood transfusion, and an intravenous proton pump inhibitor was started. Ibuprofen was discontinued. Her haemoglobin stabilised, and she had no further episodes of haematemesis or melaena. Subsequent testing for H. pylori was negative. She was managed conservatively and discharged on oral proton pump inhibitor therapy. Aspirin was continued after discussion with the cardiology team. She was advised to avoid all NSAIDs. No rechallenge with ibuprofen was performed.

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.

Log in to assess "Haematemesis in a 68-year-old on ibuprofen and low-dose aspirin"

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.