Severe Lactic Acidosis and Acute Kidney Injury in a 74-Year-Old Woman
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
Ward round presentation. A 74-year-old woman was admitted from the emergency department with a three-day history of vomiting, abdominal pain, and poor oral intake. Her background includes type 2 diabetes mellitus, hypertension, and heart failure with preserved ejection fraction. Her regular medications are metformin 500 mg twice daily for two years, lisinopril 10 mg once daily for five years, and furosemide 40 mg once daily for the last eight months. She had been taking these as usual until the day before admission when she could not tolerate them due to vomiting. On initial assessment, she was lethargic but rousable. Blood pressure 90/58 mmHg, heart rate 108 bpm, respiratory rate 26/min, temperature 36.9°C. There was no focal abdominal tenderness or peritonism. Mucous membranes were dry. Initial investigations: arterial blood gas showed pH 7.08, bicarbonate 10 mmol/L, lactate 9.0 mmol/L, PaCO2 2.9 kPa. Serum creatinine 240 µmol/L (eGFR 22 mL/min/1.73 m²), urea 28 mmol/L. A urine dipstick was negative for blood and leukocytes. There was no history of recent alcohol excess. A serum metformin concentration drawn on admission was 12.3 mg/L (therapeutic range 0.5-5 mg/L). Her medications were continued on admission. She received 2 litres of intravenous 0.9% sodium chloride over four hours. A repeat lactate after rehydration was 8.2 mmol/L. The clinical impression was lactic acidosis with acute kidney injury. Her oral antihyperglycaemic agent, metformin, was withheld, and supportive care was continued. Over the next 48 hours, her lactate fell to 1.5 mmol/L, and her creatinine improved to 120 µmol/L. She made an uneventful recovery. The differential diagnosis included septic shock, but there was no fever, leukocytosis, or source. The temporal relationship between the withholding of metformin and the improvement in acidosis supports a causal link.
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.
Log in to assess "Severe Lactic Acidosis and Acute Kidney Injury in a 74-Year-Old Woman"
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.
Taught in
More like this
- Prolonged hypoglycaemia in an 84-year-old man with chronic kidney disease
- Acute kidney injury in a 78-year-old woman with recent gastroenteritis and new NSAID use
- Acute kidney injury in a diabetic man after contrast CT
- Acute dystonia in a 22-year-old man after haloperidol
- Sore throat, fever and neutropenia in a patient on clozapine
- Statin-induced myopathy after a dose increase in a 66-year-old woman
Educational content for students and clinicians in training. It does not replace professional judgement, local protocols or current prescribing information.