Fluoride topical Pregnancy and Breastfeeding Warnings

Brand names: ACT Fluoride Rinse, ACT Restoring Mouthwash Mint, Biotene, Clinpro 5000, Denta 5000 Plus, Dentagel, Fluoridex, Fluoridex Daily Defense, Gel-Kam, Ionite APF Gel, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, NaFrinse Weekly, OrthoWash, Phos-Flur, Phosphate Fluoride, PreviDent 5000 Booster, PreviDent Gel, Prevident, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident Mouthwash, Purelife APF Gel, SF 5000 Plus, Tandem Perio Rinse

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Fluoride topical Pregnancy Warnings

Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Adverse effects on reproduction have been reported in animals exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other animal studies reported that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Animal studies have reported that fluoride crosses the placenta, but only 0.01% of the amount administered is incorporated in fetal issues.

Maternal animal exposure to 12.2 mg fluoride/kg of body weight or 13.1 mg/kg of body weight did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations.

Fluoride topical has been assigned to pregnancy category B by the FDA. Animal studies have shown that fluoride is not a teratogen. There are no controlled data in human pregnancy. Fluoride topical should be given during pregnancy when need has been clearly established.

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Fluoride topical Breastfeeding Warnings

There are no data on the excretion of fluoride into human milk. Because many drugs are excreted in milk, caution is recommended if products containing fluoride are administered to a nursing woman.

Reduced milk production was reported in farm-raised animals when they were fed a diet containing a high concentration of fluoride (98 to 137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in animals administered fluoride up to 5 mg/kg of body weight.

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Further information

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