Adverse Drug Reaction Trainer

Achilles tendon rupture in a man on ciprofloxacin and prednisolone

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 62-year-old man presented to the emergency department with sudden left heel pain and difficulty walking. He had been well until that morning, when he felt a snapping sensation in his left heel while getting out of bed. He was unable to bear weight on the affected leg. He reported no previous injury or similar symptoms.

His medical history included chronic obstructive pulmonary disease (COPD). Ten days earlier he had been admitted to a respiratory ward with an exacerbation of COPD. On that day, he was started on oral prednisolone 40 mg once daily, which he had continued taking. Five days into the admission, he developed a urinary tract infection, and ciprofloxacin 500 mg twice daily was commenced. His other regular medications included salbutamol and tiotropium inhalers.

Examination showed marked swelling and bruising over the left heel, with a visible gap in the Achilles tendon. The Thompson's test was positive. An ultrasound and subsequent magnetic resonance imaging confirmed a complete rupture of the left Achilles tendon.

Ciprofloxacin was stopped immediately on suspicion of an adverse drug reaction. The patient was referred to the orthopaedic team. He underwent surgical repair of the tendon, followed by immobilisation in a below-knee cast. His prednisolone was continued at a reduced dose, with stress-dose cover during the perioperative period. There was no immediate change in his symptoms after stopping ciprofloxacin, as the rupture had already occurred. No rechallenge was performed.

The treating team considered possible causes. The patient's age and the concurrent use of prednisolone are recognised risk factors for Achilles tendon rupture. However, the temporal relationship with ciprofloxacin, a drug well known to cause tendinopathy and tendon rupture, was also a key consideration. He had no prior exposure to fluoroquinolones. The event was reported to the pharmacovigilance database for further analysis.

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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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.