Fluorometholone ophthalmic Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Nov 4, 2022.

Fluorometholone ophthalmic is also known as: Eflone, FML, FML Forte Liquifilm, FML Liquifilm, FML S.O.P., Flarex, Fluor-Op

Fluorometholone ophthalmic Pregnancy Warnings

Use is not recommended.

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

Animal studies have shown this drug to be embryocidal and teratogenic. 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

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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Fluorometholone ophthalmic 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: Data not available

Comments:
-Systemically-administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other effects.

See references

Further information

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