Boostrix vaccine Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned
Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Available data from patients who received this vaccine during or within 30 days prior to pregnancy show major birth defect and miscarriage rates consistent with estimated background rates.
Animal studies showed no evidence of fetal harm. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.
There is a registry that monitors pregnancy outcomes in women exposed to this vaccine during pregnancy. To enroll in or obtain information about the registry, please call Sanofi Pasteur for ADACEL(R) at 800-822-2463 or GlaxoSmithKline for BOOSTRIX(R) at 888-452-9622.
AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
See references
Boostrix vaccine Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
See references
