Durysta Pregnancy Warnings
Animal studies have shown reproductive toxicity at high maternotoxic doses. There are no adequate and well-controlled studies in pregnant women.
AU TGA pregnancy category B3: 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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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 is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.
Risk summary: Postmarketing reports suggest that malformative risk with use of this drug in pregnant women is unlikely.
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Durysta Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.
-Some experts recommend placing pressure over the tear duct by the corner of the eye for at least 1 minute and removing excess solution with an absorbent tissue to substantially reduce the amount of drug that reaches breast milk after using eye drops.
See references
