Euglycaemic ketoacidosis after fasting in a 58-year-old man with diabetes
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 Naranjo probability scale.
Naranjo probability scale
- Framework
- Naranjo probability scale
- You decide
- Suspect drug, reaction, severity, seriousness, causality
The case
A 58-year-old man presented to the emergency department with a 24-hour history of nausea, vomiting, and diffuse abdominal pain. He had a background of type 2 diabetes mellitus and hypertension. His regular medications were metformin 500 mg twice daily, dapagliflozin 10 mg once daily, and lisinopril 10 mg once daily. He had been taking dapagliflozin for the past 3 months; metformin and lisinopril had been prescribed for several years. In preparation for a scheduled colonoscopy, he had been fasting from 08:00 the previous day and took his usual morning medications that day. Over the following hours he became increasingly unwell with repeated vomiting and documented ketonuria at home. On arrival at the hospital he was markedly dehydrated, with a blood pressure of 105/65 mmHg, heart rate 110 beats/minute, respiratory rate 28 breaths/minute, and oxygen saturation of 96% on room air. He was drowsy but rousable. The arterial blood gas showed pH 7.18, bicarbonate 10 mmol/L, and pCO2 2.1 kPa. His blood glucose was only 12 mmol/L, with capillary ketones of 5.0 mmol/L. Serum sodium was 128 mmol/L, potassium 5.2 mmol/L, creatinine 120 µmol/L, and lactate 1.2 mmol/L. Chest radiograph and urine cultures were negative. The clinical picture was consistent with euglycaemic diabetic ketoacidosis. He was treated with intravenous 0.9% sodium chloride and an insulin infusion; dapagliflozin was withheld. Over the next 36 hours his ketones cleared and the acidosis resolved. He made a full recovery. No rechallenge with the drug was performed. A diagnosis of metformin-associated lactic acidosis was considered, but the normal lactate excluded it.
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 Naranjo probability scale 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.