Fungal infections of the cornea are particularly prone to develop coincidentally with longterm
local steroid application. Fungus invasion must be considered in any persistent corneal ulceration
where a steroid has been used or is in use.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No studies have been conducted in animals or
in humans to evaluate the possibility of these effects with fluorometholone.
Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when
administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to
rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including
cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele,
craniorachischisis, and spina bifida were observed. There are no adequate and well controlled studies
of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal
harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
Systemically administered corticosteroids appear in human milk and could suppress
growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not
known whether topical administration of corticosteroids could result in sufficient systemic absorption
to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution
should be exercised when FLAREX (fluorometholone acetate ophthalmic suspension), is administered
to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety or effectiveness have been observed between elderly
and younger patients.