BabyBIG® - Infant Botulism Treatment

FFF Enterprises Exclusive Product

What Is Infant Botulism?

Infant botulism is caused by ingested spores of the bacterium Clostridium botulinum, which colonize and grow in the infant's large intestine and produce the botulinum toxin. The action of the toxin in the body produces the following infant botulism symptoms: constipation, weakness (notably gag, cry, suck and swallow), loss of muscle tone, and ultimately, flaccid paralysis. Affected infants have difficulty feeding and often, breathing. However, in the absence of complications, patients recover completely from the disease.
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If you have a patient suspected of having infant botulism:

  • Call (510) 231-7600, 24 hours a day, 7 days a week, 365 days a year
  • For more information about infant botulism and securing BabyBIG:
  • To send IBTPP non-urgent questions or comments:


U.S. Food & Drug Administration

Proper Name: Botulism Immune Globulin Intravenous (Human)
Tradename: BabyBIG
Manufacturer: California Department of Public Health
Indication: BabyBIG is an immune globulin intravenous (IVIG) (human) indicated for the treatment of infant botulism caused by toxin types A or B in patients below one year of age.
Product Information: BabyBIG Prescribing Information

BabyBIG: Definitive Early Immunotherapy for Infant Botulism

Behind this highly effective public service orphan drug is a remarkable story of innovation, faith and perseverance.


Botulinum toxin is produced by the spore-forming, anaerobic bacterium Clostridium botulinum or other closely related bacterial species. It is the most poisonous substance known, natural or synthetic. The median lethal dose in adults is around one to two ten millionths of a gram when injected, or roughly 10 times that much when inhaled. Once carried through the bloodstream to the peripheral neuromuscular synapses, botulinum toxin blocks release of the acetylcholine neurotransmitter to muscle, resulting in hypotonia and flaccid paralysis. Without aggressive, around the-clock medical support, death from a lethal exposure to botulinum toxin usually results from airway obstruction due to paralysis of pharyngeal muscles that control swallowing and airway diameter.  [Continue Reading]