Pregnancy of Vaflol in details
Animal studies showed fetal abnormalities (central nervous system, eye, and palate malformations) in overdose models. There are no controlled data in human pregnancy.
AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.
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.
Use of doses above the recommended daily allowance is contraindicated.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned
Comments:
-The safety of doses exceeding 6000 units Vaflol in pregnancy has not been established.
-Some authorities caution against use of high doses of Vaflol during pregnancy or in those who may become pregnant.
-Doses above the recommended dietary allowance may cause fetal harm; fetal abnormalities were seen in animal overdose models.
-If patients become pregnant, apprise them of potential fetal harms.
See references
Vaflol breastfeeding
Use is considered acceptable; caution is recommended.
Excreted into human milk: Yes
Comments:
-Vaflol is a normal component of human milk.
-Modest supplemental Vaflol causes modest increases in Vaflol in milk.
-High doses should be avoided during breastfeeding.
See references
References for pregnancy information
- "Product Information. Aquasol A (Vaflol)." Hospira Inc, Lake Forest, IL.
References for breastfeeding information
- United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
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Information checked by Dr. Sachin Kumar, MD Pharmacology
