Pediatric Annals

Letters to the Editor 

Source of Botulinum Antitoxin Products Needs Clarifying

Ryan P. Fagan, MD, MPH

Abstract

Note: The findings and conclusions in this letter are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).

Abstract

Note: The findings and conclusions in this letter are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).

Note: The findings and conclusions in this letter are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).

To the Editor:

We read with interest the case report of a Colorado infant with type F botulism [“A 3-day-old Boy with Acute Flaccid Paralysis.” Pediatr Ann. 2009;38(9):479–482]. The purpose of our letter is to clarify the sources of the two botulinum antitoxin products administered to the patient in this report.

Specific treatment for botulism patients in the United States is available only through consultation with public health authorities. BabyBIG (BIG-IV; Botulism Immune Globulin Intravenous [Human]) is approved for treatment of infant botulism types A and B. It is manufactured by the California Department of Health Services and is available on a 24-hour basis through the California Infant Botulism Treatment and Prevention Program (IBTPP).1 Botulism antitoxins intended for use in older children and adults are equine-derived and are available on a 24-hour basis from the U.S. Centers for Disease Control and Prevention (CDC). The investigational heptavalent botulinum antitoxin (HBAT, Cangene Corporation) administered to the patient in this report is manufactured under contract with the U.S. Department of Health and Human Services (HHS) and provided through the CDC, not the Department of Defense (DoD), as reported in the article.

The Colorado patient was, to date, the only infant in the United States to receive Cangene’s HBAT. Use of HBAT in this scenario required implementation of an Emergency Investigational New Drug (IND) protocol after consultation among the treating clinicians, the Colorado Department of Public Health and Environment, CDC, IBTPP, the Food and Drug Administration (FDA), and Cangene Corporation.

Cangene’s HBAT product contains neutralizing antibody to the seven known botulinum toxin types (A–G) with the following nominal potency values: 7,500 U anti-A, 5,500 U anti-B, 5,000 U anti-C, 1,000 U anti-D, 8,500 U anti-E, 5,000 U anti-F, and 1,000 U anti-G.2 After pretreatment with diphenhydramine, steroids, and morphine, the infant received two doses of HBAT administered 8 hours apart, each dose containing 10% of the adult dose (1 adult dose = 1 vial) of antitoxin. Dosing for this patient was informed, in part from the experience of treating an Ohio infant with type F botulism in 1998 (before Cangene’s HBAT was developed). The Ohio infant received a different heptavalent antitoxin product that was produced by the University of Minnesota and provided by DoD in consultation with CDC and FDA. As a result of the experience with the Colorado infant, CDC has added specific guidance about pediatric dosing to its IND HBAT protocol.

On March 13, 2010, investigational HBAT replaced a previously licensed botulinum antitoxin AB (BAT-AB) and investigational monovalent type E antitoxin (BAT-E) as the primary antitoxin for treatment of noninfant botulism in the United States.2 Importantly, types A or B botulism account for 99% of infant botulism cases in the United States,3 and BabyBIG remains the mainstay of treatment for infants. HBAT may be considered on a case-by-case basis for infants with botulism types other than A or B.

Reporting of suspect botulism cases is mandatory in the United States, and clinicians should immediately notify their state public health department of suspect cases. After initial reporting to appropriate state authorities, 24-hour consultation and treatment services for suspect cases are available for infants through IBTPP (1-510-231-7600) and for older children and adults through the CDC Emergency Operations Center (1-770-488-7100).

LCDR Ryan P. Fagan,
MD, MPH
U.S. Public Health Service
Staff Epidemiologist, Enteric
Diseases Epidemiology Branch
Centers for Disease Control and
Prevention

CAPT Hye-Joo Kim, PharmD
U.S. Public Health Service
Chief, Regulatory Affairs
Centers for Disease Control and
Prevention

References

  1. Arnon SS, Schechter R, Maslanka SE, Jewell NP, Hatheway CL. Human botulism immune globulin for the treatment of infant botulism. N Engl J Med. 2006;354(5):462–471. doi:10.1056/NEJMoa051926 [CrossRef]
  2. Centers for Disease Control and Prevention (CDC). Investigational heptavalent botulinum antitoxin (HBAT) to replace licensed botulinum antitoxin AB and investigational botulinum antitoxin E. MMWR Morb Mortal Wkly Rep. 2010;59(10):299.
  3. Fagan RP, Biggerstaff M, Luquez C, Swerdlow D. Botulism in the U.S. — 1998–2007 (oral abstract). 47th Annual Meeting of the Infectious Disease Society of America. . Philadelphia, PA. ; 2009.

10.3928/00904481-20100422-02

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