Adverse Drug Reaction Trainer

Prolonged hypoglycaemia in an 84-year-old man with chronic kidney disease

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

Presentation

An 84-year-old man was brought to the emergency department by his daughter with confusion and a Glasgow Coma Scale (GCS) of 10. At home, she had found him unresponsive to voice and had measured a capillary blood glucose of 1.8 mmol/L. He had been given an immediate intravenous bolus of 10% glucose (100 mL), which improved his GCS to 14.

Medication history

He had type 2 diabetes mellitus diagnosed 12 years ago. His regular medications were:

  • Glibenclamide 5 mg twice daily, started five years ago.
  • Bisoprolol 2.5 mg once daily, started eight months ago for hypertension and rate control.
  • Lisinopril 10 mg once daily, started one year ago for hypertension and renal protection.
  • Atorvastatin 20 mg at night, started two years ago.

He had no known drug allergies.

Timeline

Two weeks before admission, he had a chest infection and was prescribed amoxicillin 500 mg three times daily by his general practitioner. His appetite had reduced significantly, and he ate very little for four days. He had no vomiting or diarrhoea. On the day before admission, he continued to eat poorly. On the day of admission, his daughter found him confused.

After initial stabilisation, his blood glucose continued to fall, requiring repeated intravenous dextrose infusions. The medical team noted that he had not received any insulin.

Examination and investigations

On admission, his temperature was 36.8°C, pulse 84 beats per minute, blood pressure 154/78 mmHg. After further assessment, there were no signs of infection; the chest infection had resolved. His weight was 70 kg.

Biochemistry:

  • Blood glucose: 1.8 mmol/L (repeated).
  • Serum creatinine: 200 µmol/L (estimated GFR 30 mL/min/1.73 m²). This was stable for the last six months.
  • Urea: 14 mmol/L.
  • Liver function tests: normal.
  • Sepsis screen: negative.
  • During a hypoglycaemic episode, serum C-peptide was elevated and insulin was high, consistent with a sulfonylurea effect.
  • HbA1c was 7.0% (53 mmol/mol) three months ago.

Course in hospital

He was treated with repeated 5% dextrose infusion, and the hypoglycaemia persisted for 12 hours after admission. The sulfonylurea was withheld on the second day. His glucose stabilised within 24 hours and did not require further dextrose. His other medications were continued.

On day 3, a misplaced medication chart resulted in his usual glibenclamide dose being administered inadvertently. Two hours later, his blood glucose fell to 3.2 mmol/L, and he required oral glucose. This confirmed the association.

He recovered without neurological deficits and was switched to a more appropriate glycaemic control for renal impairment.

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 "Prolonged hypoglycaemia in an 84-year-old man with chronic kidney disease"

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.