Skip to Content
Get key facts and figures about chronic dry eye

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

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.

See references

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

References for pregnancy information

  1. "Product Information. Flarex (fluorometholone ophthalmic)." A-S Medication Solutions, Chicago, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. FML Ophthalmic Suspension (fluoromethalone ophthalmic)." Allergan Inc, Irvine, CA.

References for breastfeeding information

  1. "Product Information. FML Ophthalmic Suspension (fluoromethalone ophthalmic)." Allergan Inc, Irvine, CA.
  2. "Product Information. Flarex (fluorometholone ophthalmic)." A-S Medication Solutions, Chicago, IL.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

See Also...

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.

Hide