Skip to Content

Fluoride topical Pregnancy and Breastfeeding Warnings

Fluoride topical is also known as: ACT Restoring Mouthwash Cinnamon, Biotene, Clinpro 5000, Colgate Total Whitening Gel, Control Rx, ControlRx Toothpaste, Denta 5000 Plus, Dentagel, Denti-Care Denti-Pro, Ethedent, Fluoridex, Gel-Kam, Gelato X, Mentadent Advanced Breath Freshening, Neutramaxx 5000 Plus Turbo, Perio Med, PreviDent 5000 Booster, Prevident, Prevident 5000 Plus, Prevident Dental Rinse, Prevident Mouthwash, SF, SF 5000 Plus, VividSensiGuard, Zooby

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.

See references

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.

See references

References for pregnancy information

  1. "Product Information. Fluoridex (fluoride topical)." Discus Dental, Culver City, CA.

References for breastfeeding information

  1. "Product Information. Fluoridex (fluoride topical)." Discus Dental, Culver City, CA.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and 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.