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Fluorometholone ophthalmic Pregnancy and Breastfeeding Warnings

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

Fluorometholone ophthalmic Pregnancy Warnings

FDA pregnancy category: C Potential benefit should outweigh the potential risk.

Animal data have revealed evidence of teratogenicity and embryotoxicity following low multiples of the recommended human ophthalmic dose. When applied ocularly to animals, dose related fetal loss and abnormalities such as cleft palate, deformed rib cage, anomalous limbs and neural abnormalities (encephalocele, craniorachischisis, spina bifida) were observed. There are no controlled data in human pregnancy. 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.

Fluorometholone ophthalmic Breastfeeding Warnings

It is not known whether topical administration results in enough system absorption to produce detectable quantities in human milk.

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Flarex: Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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