Fluoride topical Pregnancy and Breastfeeding Warnings
Fluoride topical is also known as: ACT Fluoride Rinse, APF Gel, Control Rx, Denta 5000 Plus, Dentagel, Denti-Care Denti-Foam, Denti-Care Denti-Pro, Ethedent, Fluoridex, Fluoridex Daily Defense, Gel-Kam, Neutral Sodium Fluoride Rinse, Omni-Med, Perfect Choice, Phos-Flur, PreviDent 5000 Booster, Prevident, Prevident 500 Plus Boost, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop
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.
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.
- sodium fluoride cream Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com 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 drug information 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 drug combination in no way should be construed to indicate that the drug or drug 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 in 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.