8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no available human data that establish developmental toxicity related to the use of North American Coral Snake Antivenin (Equine). There are no available animal data informing the North American Coral Snake Antivenin (Equine)-associated risk. North American Coral Snake Antivenin (Equine) should be given to a pregnant woman only if clearly required. In the US general population, the background risk of major birth defects is 2–4% and of miscarriage is 15–20% in clinically recognized pregnancies.
8.2 Lactation
Risk Summary
Lactation studies have not been conducted with North American Coral Snake Antivenin (Equine). It is not known whether North American Coral Snake Antivenin (Equine) is excreted in human milk. North American Coral Snake Antivenin (Equine) should be administered to lactating women only if clearly indicated. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for North American Coral Snake Antivenin (Equine) and any potential adverse effects on the breastfed child from North American Coral Snake Antivenin (Equine) or from the underlying maternal condition.
8.4 Pediatric Use
Controlled clinical studies of safety and effectiveness in pediatric patients have not been conducted.
Potential cases of Coral Snake envenomation and subsequent treatment with North American Coral Snake Antivenin (Equine) have been reported in pediatric patients;2 adverse reactions included anaphylaxis (wheezing) requiring treatment with epinephrine, vomiting, and abdominal pain.