Iatrogenic Botulism Outbreak in Egypt due to a Counterfeit Botulinum Toxin A Preparation – A Descriptive Series of Patient Features and Outcome

Abstract

Abstract Iatrogenic botulism resulting from the substantial increase in use of botulinum neurotoxin type A (Bo NT ‐A) treatment is rarely reported. We aimed to describe a large iatrogenic botulism outbreak in Egypt in June–July 2017. Nine patients developed botulism after receiving intramuscular injections of Bo NT ‐A (dose: 200–300 IU) to treat cerebral palsy (N = 7), spastic dystonia (N = 1) and hyperhidrosis (N = 1). Detailed findings were available in five of nine cases. Patients were admitted to the hospital 5‐10 days after the Bo NT ‐A injection. Complaints included muscle weakness in the upper and lower limbs (N = 5), dysphagia (N = 5), dizziness (N = 2), dyspnoea (N = 2), dysphonia (N = 2), dysarthria (N = 2), fatigue (N = 1), diplopia (N = 1) and blurred vision (N = 1). Physical examination showed bilateral ptosis (N = 5), diminished gag reflex (N = 2), ophthalmoparesis (N = 1), facial paresis (N = 1) and tongue weakness (N = 1). Diagnosis was based on the patients' history and presentation and did not require any confirmatory test. On hospital admission, patients received supportive care and trivalent botulism type A/B/E antitoxin (250–500 IU) was started. No patient required mechanical ventilation. Immediate reversal of the most severe features was observed while varying degrees of peripheral muscular weakness persisted. Full recovery required 6–12 weeks. Cases were promptly reported to the Egyptian health authorities, and epidemiological investigations revealed that the outbreak was related to a recently imported highly concentrated unlicensed Bo NT ‐A preparation sold as Neuroxin ® . Immediate withdrawal from the market was ordered. In conclusion, iatrogenic botulism outbreak due to counterfeit botulism toxin may result in life‐threatening features. The early administration of botulism antitoxin in addition to supportive care is life‐saving. Clinicians should remain mindful of the risk of systemic botulism with Bo NT ‐A therapy.