Fluorometholone ophthalmic Pregnancy and Breastfeeding Warnings
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.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.