Adverse Drug Reaction Trainer

A 65-year-old man with a falling platelet count and a leg DVT on day 7 of surgery

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

The patient is a 65-year-old man who underwent elective left total hip replacement. On the first postoperative day, he was started on unfractionated heparin 5000 units subcutaneously twice daily for thromboembolic prophylaxis. His regular medications included lisinopril 10 mg once daily for hypertension and oxycodone 10 mg every 6 hours for pain. He was also receiving cefazolin 1 g intravenously every 8 hours as surgical prophylaxis. On day 5, his platelet count was 260 x 10^9/L, compared with a baseline of 280 x 10^9/L. On day 7, he reported pain and swelling in his left calf. He was afebrile and his vital signs were stable. Examination showed left calf oedema and tenderness. Duplex ultrasound confirmed a left popliteal deep vein thrombosis. Laboratory results: platelet count 70 x 10^9/L, haemoglobin 11.2 g/dL, white cell count 12.0 x 10^9/L. A repeat platelet count was 62 x 10^9/L. He had no other risk factors for thrombosis, and there was no laboratory or clinical evidence of infection. All heparin was stopped, and he was started on an alternative anticoagulant. Over the following three days, the platelet count rose to 120 x 10^9/L and to 220 x 10^9/L by day 12. The leg swelling resolved gradually. The patient was not rechallenged with heparin.

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 "A 65-year-old man with a falling platelet count and a leg DVT on day 7 of surgery"

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.