Flurbiprofen ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Ocufen

Medically reviewed by Drugs.com. Last updated on Jun 20, 2023.

Flurbiprofen ophthalmic Pregnancy Warnings

AU, US: Use should be avoided
UK: Use should be avoided during the first two trimesters of pregnancy; use is contraindicated during the third trimester of pregnancy

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

Comments:
-Studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.
-If this drug is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of therapy as short as possible.
-During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension), renal dysfunction (which may progress to renal failure with oligo-hydroamniosis).
-All prostaglandin synthesis inhibitors may expose both the mother and the neonate to possible prolongation of bleeding time and the mother to inhibition of uterine contractions resulting in delayed or prolonged labor.

Animal studies have shown increased pre- and post-implantation loss and embryo-fetal lethality. Additionally, increased incidences of various malformations, including cardiovascular, have been reported. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Flurbiprofen 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: The effects in the nursing infant are unknown.

See references

Further information

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