0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
From the Centers for Disease Control and Prevention |

Investigational Heptavalent Botulinum Antitoxin (HBAT) to Replace Licensed Botulinum Antitoxin AB and Investigational Botulinum Antitoxin E FREE

JAMA. 2010;303(21):2135. doi:.
Text Size: A A A
Published online

MMWR. 2010;59:299

CDC announces the availability of a new heptavalent botulinum antitoxin (HBAT, Cangene Corporation) through a CDC-sponsored Food and Drug Administration (FDA) Investigational New Drug (IND) protocol. HBAT replaces a licensed bivalent botulinum antitoxin AB and an investigational monovalent botulinum antitoxin E (BAT-AB and BAT-E, Sanofi Pasteur) with expiration of these products on March 12, 2010. As of March 13, 2010, HBAT became the only botulinum antitoxin available in the United States for naturally occurring noninfant botulism.

Botulinum antitoxin for treatment of naturally occurring noninfant botulism is available only from CDC. The transition to HBAT ensures uninterrupted availability of antitoxin. BabyBIG (botulism immune globulin) remains available for infant botulism through the California Infant Botulism Treatment and Prevention Program.1 BabyBIG is an orphan drug that consists of human-derived botulism antitoxin antibodies and is approved by FDA for the treatment of infant botulism types A and B.

HBAT contains equine-derived 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. HBAT is composed of <2% intact immunoglobulin G (IgG) and ≥90% Fab and F(ab′)2 immunoglobulin fragments; these fragments are created by the enzymatic cleavage and removal of Fc immunoglobulin components in a process sometimes referred to as despeciation. Fab and F(ab′)2 fragments are cleared from circulation more rapidly than intact IgG,2 and repeat HBAT dosing might be indicated for some wound or intestinal colonization patients if in situ botulinum toxin production continues after clearance of antitoxin.

The HBAT FDA IND treatment protocol includes specific, detailed instructions for intravenous administration of antitoxin and return of required paperwork to CDC. Health-care providers should report suspected botulism cases immediately to their state health department; all states maintain 24-hour telephone services for reporting of botulism and other public health emergencies. Additional emergency consultation is available from the CDC botulism duty officer via the CDC Emergency Operations Center, telephone, 770-488-7100.3 Additional information regarding CDC's botulism treatment program is available at http://www.bt.cdc.gov/agent/botulism.

REFERENCES

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
PubMed   |  Link to Article
Sevcik C, Salazar V, Diaz P, D’Suze G. Initial volume of a drug before it reaches the volume of distribution: pharmacokinetics of F(ab’)2 antivenoms and other drugs.  Toxicon. 2007;50(5):653-665
PubMed   |  Link to Article
CDC.  New telephone number to report botulism cases and request antitoxin.  MMWR. 2003;52:774

Figures

Tables

References

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
PubMed   |  Link to Article
Sevcik C, Salazar V, Diaz P, D’Suze G. Initial volume of a drug before it reaches the volume of distribution: pharmacokinetics of F(ab’)2 antivenoms and other drugs.  Toxicon. 2007;50(5):653-665
PubMed   |  Link to Article
CDC.  New telephone number to report botulism cases and request antitoxin.  MMWR. 2003;52:774
CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Related Collections
PubMed Articles