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

Iatrogenic botulism resulting from the substantial increase in use of botulinum neurotoxin type A (BoNT-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 BoNT-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 BoNT-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 BoNT-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 BoNT-A therapy.