Diclofenac / menthol topical Pregnancy and Breastfeeding Warnings

Brand names: DicloStream

Medically reviewed by Drugs.com. Last updated on Oct 18, 2023.

Diclofenac / menthol topical Pregnancy Warnings

Not recommended during last trimester of pregnancy
Prior to 30 weeks gestation, use only if potential benefit justifies the potential risk to the fetus

US FDA pregnancy category: C prior to 30 weeks gestation
US FDA pregnancy category: D starting at 30 weeks gestation

Reproductive and developmental studies of diclofenac administration in animals during organogenesis have not shown teratogenicity. In rats, maternally toxic doses of diclofenac have been associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. Administration of NSAIDs to humans during the latter part of pregnancy has been associated with premature closure of the fetal ductus arteriosus. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. There are no adequate and well controlled studies of diclofenac or other NSAIDs in pregnant women.

The use of drugs known to inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility; consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility.

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.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Diclofenac / menthol topical Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Yes (oral drug)

Comments: There is no data on the topical use of this drug and breastfeeding; limited data on oral diclofenac administration show excretion into milk is poor.

Study data describing excretion of diclofenac into human milk is lacking. Limited published data describes excretion into milk as poor following oral administration. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

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Further information

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