Aldurazyme Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B2
US FDA pregnancy category: B
Animal studies have failed to reveal evidence of fetal harm or impaired fertility. There are no controlled data in human pregnancy.
Pregnant women are encouraged to register themselves in the MPS I registry. For additional information: MPSIregistry.com
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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references
Aldurazyme Breastfeeding Warnings
Nursing mothers are encouraged to register themselves in the MPS I registry. For additional information: MPSIregistry.com
Caution is recommended; according to some experts, use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
See references
