Dexamethasone ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: AK-Dex, Decadron Ocumeter, Decadron Phosphate, Ophthalmic, Dexasol, Dextenza, Dexycu, Maxidex, Ocu-Dex, Ozurdex

Medically reviewed by Drugs.com. Last updated on Nov 20, 2023.

Dexamethasone ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments: Corticosteroids should not be used extensively on pregnant patients, in large amounts or for extended periods of time.

Animal studies have shown teratogenic effects following topical ophthalmic administration. There are no adequate and well-controlled studies in pregnant women on the teratogenic effects from topically applied corticosteroids.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Dexamethasone ophthalmic Breastfeeding Warnings

Use is not recommended and 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: Yes; however, it is not known whether intravitreal administration could result in sufficient systemic absorption to produce detectable quantities in human milk.

Comments: The effects in the nursing infant are unknown.

See references

Further information

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