Abstract
Infant botulism is the intestinal (infectious) toxemia in which swallowed spores of Clostridium botulinum activate in the lumen of the colon and thereby produce botulinum toxin, which after absorption causes flaccid paralysis. Human Botulism Immune Globulin (BIG-IV) neutralizes botulinum toxin types A and B. The US FDA licensed BIG-IV to the California Department of Public Health, its creator and developer, as the public service orphan drug BabyBIG ® in October 2003 (N. Engl. J. Med. 2006;354:462–471). International distribution began on a trial basis in July 2005. This report summarizes the 2003–2007 distribution, efficacy and safety data for BIG-IV. In the US, a total of 333 eventually laboratory-confirmed patients residing in 35 states were treated within 1 week of hospital admission: 142 type A, 188 type B, 2 type Ba and 1 type Bf. Mean length of hospital stay was 2.2±1.5 vs. 5.7±5.1 wks for untreated patients in the 1992–97 BIG-IV randomized clinical trial ( P ® ), its use globally to treat infant botulism patients has demonstrated its continued safety, efficacy and US cost-effectiveness.
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