Botulism is a rare but serious illness that causes descending paralysis. Children under the age of 12 months are most at risk of infection. Botulism can occur following the ingestion of contaminated food, soil or dust. Care should be taken when canning fruit, vegetables and meat at home.
For further information please see the fact sheet or contact your local public health unit on 1300 066 055.
Information for health professionals
See reference: Sobel J. Botulism. Clin Infect Dis. (2005) 41(8):1167-1173. doi: 10.1086/444507 .
Confirmation of botulism requires:
- isolation of C. botulinum in a clinical sample, or
- detection of the C. botulinum toxin in serum or stool specimens.
Laboratory testing for Clostridium botulinum toxin is available at ICPMR-Pathology West (Discuss with the Clinical Microbiologist on call, (02) 9845-6255).
Botulism antitoxins for treatment
Botulinum immunoglobulin (BabyBIG®) derived from human donors for the treatment of infant botulism (< 1 year of age) is available from the California Department of Public Health.
Equine-derived heptavalent antitoxin (BAT®) for older children and adults is available through NSW Health from the national stockpile.
These two botulinum antitoxin products (described below) can be considered for the treatment of suspected or confirmed botulism in addition to supportive treatment. In infant botulism (or other forms of intestinal botulism), antibiotics are not used to treat the infection because of the risk that lysis of intraluminal Clostridium botulinum may increase the amount of toxin available for absorption.
If botulinum antitoxin is to be used it should be administered as soon as possible. Antitoxin does not reverse paralysis but arrests its progression. Skin testing for sensitivity to antitoxin should be performed before administration.
The preferred product for the treatment of infant botulism is BabyBIG®. Consider BAT® for infants requiring treatment if BabyBIG® is unavailable or its delivery is likely to be significantly delayed.
Treating clinicians need to consider the following points:
- BabyBIG® is only recommended for use in the treatment of infant botulism caused by C. botulinum producing serotype A or B toxins (Note that these two toxin types have been responsible for all recent cases of infant botulism in NSW).
- BabyBIG® needs to be sent from the United States. While previous requests have resulted in supply of the product within 48 hours there is a risk of longer delays.
BabyBIG® - Botulinum Immunoglobulin for Infant Botulism
- BabyBIG® is a botulism immunoglobulin product for intravenous use collected from vaccinated human donors with high titres of antibodies to serotype A and serotype B botulinum toxins, and is licensed by the USFDA for the treatment of infant botulism caused by these toxin serotypes.
- Each single-use vial contains 100 mg ± 20 mg lyophilized immunoglobulin. When reconstituted it contains approximately 30 international units (IU) against serotype A toxin and approximately 8 IU against serotype B toxin. For toxin serotypes A and B, 1 IU of botulinum antitoxin (by definition) neutralizes 10,000 Mouse Intraperitoneal LD50 (MIPLD50) of botulinum toxin.
- The recommended dose is 1.0 mL/kg (50 mg/kg) given as a single intravenous infusion. Refer to the full prescribing information.
- BabyBIG® is made and distributed by the California Department of Public Health (24-hour telephone number (USA): 0011-1-510-231-7600; BabyBIG® website). The current cost of the product is US$45,300 per vial.
BAT® - Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)
- BAT is licensed by the US Food and Drug Administration (USFDA) For the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and paediatric patients.
- The product potency is expressed in units based on the mouse neutralization assay (MNA). Each unit (U) of BAT® is designed to neutralize 10,000 MIPLD50 of botulinum toxin for serotype A, B, C, D, F, and G and 1,000 MIPLD50 of serotype E.
- Each single-use vial contains a minimum potency of:
- 4,500 U for serotype A antitoxin,
- 3,300 U for serotype B antitoxin,
- 3,000 U for serotype C antitoxin,
- 600 U for serotype D antitoxin,
- 5,100 U for serotype E antitoxin,
- 3,000 U for serotype F antitoxin, and
- 600 U for serotype G antitoxin.
- The recommended dosage for an adult is one vial. The dosage varies with the age of the patient but does not exceed one vial per patient. See the USFDA BAT information website for further prescribing information on this product.
- Emergency access to the national stockpile of BAT® for the treatment of botulism should be made through your local public health unit (1300 066 055) whose staff liaise with NSW Health CDONCALL officers.