Proquad Pregnancy Warnings
Some live virus vaccines have caused birth defects in animals. It is unknown whether this vaccine can cause fetal harm or affect reproduction capacity. Currently available live virus vaccines have not caused teratogenic effects in humans. Use caution as live virus vaccines have been shown to cross the placenta and infect the fetus.
Contracting wild-type measles during pregnancy increased rates of spontaneous abortion, stillbirth, congenital defects, and prematurity. There are no adequate studies of the vaccine strain of measles virus in pregnancy. However, it is prudent to assume that the vaccine strain is capable of inducing adverse fetal effects.
Mumps infection during the first trimester may increase the rate of spontaneous abortion. Although mumps vaccine virus can infect the placenta and fetus, there is no evidence that it causes congenital malformations in humans.
In a 10 year survey of over 700 women who received rubella vaccine within 3 months before or after conception (of whom 189 received the Wistar RA 27/3 strain), none of the newborns had rubella-like birth defects.
Wild-type varicella can cause congenital varicella infection. A pregnancy registry maintained from 1995 to 2013 tracked over 800 women who received varicella containing vaccines within 3 months prior to or during pregnancy; none of the infants had abnormalities consistent with varicella syndrome.
All exposures to varicella containing vaccines during pregnancy or within three months prior to conception should be reported as suspected adverse reactions at www.vaers.hhs.gov.
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.
Use is contraindicated.
AU TGA pregnancy category: B2
US FDA pregnancy category: Contraindication
Comments:
-Avoid pregnancy for 3 months after vaccination.
-Test women of childbearing age for rubella antibodies prior to pregnancy; offer rubella vaccine to all non-pregnant seronegative women.
See references
Proquad Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Live rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants.
-Limited evidence from women vaccinated postpartum with the vaccine strain of varicella did not detect the virus, viral DNA, or viral antigen in breast milk.
-The U.S. Centers for Disease Control and Prevention (CDC) consider the administration of live virus vaccines compatible with breast-feeding.
See references