Adverse Drug Reaction Trainer

Acute kidney injury in a 78-year-old woman with recent gastroenteritis and new NSAID use

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

Judy is a 78-year-old woman with a history of hypertension and osteoarthritis. She presents to the emergency department with a 24-hour history of nausea, vomiting, and decreased urine output. She also complains of weakness and lightheadedness on standing.

Three days before admission, she had a short episode of diarrhoea and vomiting, which she attributed to gastroenteritis. Since then, she has been unable to eat or drink much.

Her regular medications include lisinopril 10 mg once daily, bendroflumethiazide 2.5 mg once daily, and amlodipine 5 mg once daily. Five days ago, a general practitioner prescribed ibuprofen 400 mg three times daily for knee pain. She has been taking it regularly. She also takes paracetamol 500 mg occasionally, about one or two tablets per week.

On examination, she is alert but drowsy. Blood pressure is 96/58 mmHg, pulse 110 beats per minute and regular. Temperature is 36.8°C. Her mucous membranes are dry, and skin turgor is reduced. Heart sounds are normal, chest is clear. There is mild tenderness over the left knee, but no swelling.

Initial blood tests: creatinine 245 micromol/L (baseline 85 micromol/L), urea 21.5 mmol/L, sodium 136 mmol/L, potassium 5.2 mmol/L, bicarbonate 18 mmol/L. Estimated GFR is 16 mL/min/1.73 m². Haemoglobin 132 g/L, white cell count 8.9 x 10⁹/L. Urinalysis shows no blood, no protein, and no casts. Urine biochemistry shows sodium 12 mmol/L, fractional excretion of sodium 0.8%. Renal ultrasound shows two normal-sized kidneys with no obstruction.

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 "Acute kidney injury in a 78-year-old woman with recent gastroenteritis and new NSAID use"

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.