Human botulinum neurotoxin A/B immune globulin

Infant botulism is a rare infectious disease occurring in infants in which Clostridium botulinum colonize the large intestine and being to produce botulinum neurotoxin directly in the gut. As these neurotoxins interfere with cholinergic nervous transmission, patients initially present with evident of loss of muscle tone (e.g. constipation, ptosis, feeding difficulties) which may progress to more serious symptoms such as respiratory arrest and flaccid paralysis. BabyBIG (human-derived botulism immunoglobulin) was approved for use by the FDA in 2003 and has since been used to treat more than 2100 cases of infant botulism. It is produced and distributed by the Calfornia Department of Public Health's Infant Botulism Treatment and Prevention Program and comprises IgG antibodies derived from pooled adult plasma from persons immunized with recombinant botulinum vaccine who have high titers of neutralizing antibodies against botulinum toxin.