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

Abstract

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.

• Authors: Eman Abdel Monaem Abdel Rashid, Nashwa Mohamed El-Mahdy, Huda Shehata Kharoub, Ahmed Salah Gouda, Naglaa Ahmed ElNabarawy, Bruno Mégarbane
• Journal: Basic & clinical pharmacology & toxicology (Basic Clin Pharmacol Toxicol) Vol. 123 Issue 5 Pg. 622-627 (Nov 2018) ISSN: 1742-7843 [Electronic] England
• PMID: 29786953 (Publication Type: Case Reports, Journal Article)
• Copyright: © 2018 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

Chemical References

• Botulinum Antitoxin
• Counterfeit Drugs
• Immunologic Factors
• Neuromuscular Agents
• Botulinum Toxins, Type A

Topics

• Adult
• Botulinum Antitoxin (administration & dosage)
• Botulinum Toxins, Type A (administration & dosage, adverse effects)
• Botulism (diagnosis, epidemiology, etiology, therapy)
• Cerebral Palsy (drug therapy)
• Child
• Child, Preschool
• Counterfeit Drugs (administration & dosage, adverse effects)
• Disease Outbreaks (prevention & control)
• Egypt (epidemiology)
• Female
• Humans
• Iatrogenic Disease (epidemiology, prevention & control)
• Immunologic Factors (administration & dosage)
• Male
• Neuromuscular Agents (administration & dosage, adverse effects)
• Symptom Assessment