Drugs in Pregnancy and Lactation: Tenth Edition

DIPHTHERIA/TETANUS TOXOIDS (ADULT)

Toxoid

PREGNANCY RECOMMENDATION: Compatible—Maternal Benefit >> Embryo–Fetal Risk

BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible

PREGNANCY SUMMARY

Diphtheria and tetanus produce severe morbidity in the mother with mortality rates of 10% and 30%, respectively (1). In neonates, the tetanus mortality rate is 60%. The risk to the fetus from diphtheria/tetanus toxoids (Td) is unknown, but there is no evidence of teratogenicity (1,2). The CDC and the American College of Obstetricians and Gynecologists (ACOG) recommend Td booster vaccination in pregnancy if ≥10 years have elapsed since a previous Td booster or if booster protection against diphtheria is needed (3,4). If tetanus or diphtheria protection is needed during pregnancy, the diphtheria and reduced tetanus toxoids/acellular pertussis vaccine (Tdap; see Vaccine, Pertussis [Acellular]), instead of Td, may be considered in the 2nd or 3rd trimesters, or earlier if protection is needed urgently. Tdap should only be given once during a lifetime.

FETAL RISK SUMMARY

Diphtheria/tetanus toxoids (Td) for adult use are the specific toxoids of Corynebacterium diphtheriae and Clostridium tetani adsorbed onto aluminum compounds. Reproduction studies in animals have not been conducted with this product (2).

In a 1999 study using the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980–1994, database, exposure to tetanus toxoid during pregnancy was examined in 21,563 women who had offspring with congenital defects (5). The control group consisted of 35,727 women who had infants without defects. Exposure to tetanus toxoid occurred in 25 (0.12%) case women (13 in the 1st trimester) compared with 33 (0.09%) control women (17 in the 1st trimester). The difference was not significant (5).

BREASTFEEDING SUMMARY

No reports describing the use of Td during human lactation have been located. The CDC and ACOG recommend Tdap in breastfeeding women who have not received the vaccine previously or 2 years or more have elapsed since the most recent Td administration (3,4).

References

1.Amstey MS. Vaccination in pregnancy. Clin Obstet Gynaecol 1983;10:13–22.

2.Product information. Tetanus and Diphtheria Toxoids Adsorbed (for adult use). Aventis Pasteur, 2001.

3.American College of Obstetricians and Gynecologists. Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination. Committee Opinion, Number 438, August 2009.

4.Advisory Committee on Immunization Practices (ACIP). Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants. MMWR 2008;57(RR4):1–51. Available at http://www.cdc.gov/mmwr/PDF/rr/n5704.pdf. Accessed December 28, 2009.

5.Czeizel AE, Rockenbauer M. Tetanus toxoid and congenital abnormalities. Int J Gynecol Obstet 1999;64:253–8.



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