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Flurbiprofen ophthalmic Pregnancy and Breastfeeding Warnings

Flurbiprofen ophthalmic is also known as: Ocufen

Flurbiprofen ophthalmic Pregnancy Warnings

Flurbiprofen has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity and fetotoxicity, but have failed to reveal evidence of teratogenicity. After doses approximately 185 times the human topical daily dose (on a per kg basis) were given to rats, reproduction studies have shown that the drug is embryocidal and can delay parturition, prolong gestation, produce uterine hemorrhage, and damage gastric tissue. These data have shown an association between the use of flurbiprofen and the death of dams and offspring during labor, an increased incidence of stillbirths, reduced fetal weight, and slightly retarded fetal growth. There are no controlled data in human pregnancy. Flurbiprofen should only be given during pregnancy when benefit outweighs risk.

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Flurbiprofen ophthalmic Breastfeeding Warnings

There are no data on the excretion of flurbiprofen ophthalmic into human milk. Since many drugs are excreted in human milk, the manufacturer recommends that due to the potential for serious adverse reactions nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. Ocufen Liquifilm (flurbiprofen)." Allergan Inc, Irvine, CA.

References for breastfeeding information

  1. "Product Information. Ocufen Liquifilm (flurbiprofen)." Allergan Inc, Irvine, CA.

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