Abstract
Background
Fluoride varnish is widely used in dentistry as a caries preventive measure with recommendations for its use even in infants. In addition, nondental providers are also applying varnish on children’s teeth in various settings. However, there are questions from these nondental providers as to the safety of fluoride varnish.
Methods
To evaluate and describe the adverse events (AEs) related to fluoride varnish, the US Food and Drug Administration’s Manufacturer and User Facility Device Experience database was used. AEs reported for the dental product code for “varnish, cavity,” “varnish,” and “fluoride” were evaluated. The identified AEs were then reviewed and categorized using appropriate key words for the various signs and symptoms, outcomes, and treatment.
Results
Over the 10-year period, only 65 AEs were reported for fluoride varnish products. Swelling (33.8%); burning, itching, or soreness (23.1%); and rash (16.9%) were the most common signs and symptoms reported. The most common site reported was the lips (27.7%). The most common outcome was that the patient was taken to the hospital (18.5%) or emergency department (15.4%). No deaths were reported. The patients were treated primarily using diphenhydramine (Benadryl, Johnson & Johnson Consumer) (26.1%), followed by an epinephrine autoinjector (EpiPen, Mylan) and other forms of epinephrine (15.4%), and prednisolone (9.2%). In 16.9% of the cases with AEs there was a history of allergies. The rate of AEs is estimated to be between 0.099 and 0.105 per million for fluoride varnish. A concern is the likelihood of underreporting AEs in the Manufacturer and User Facility Device Experience database.
Conclusions
Given the widespread use of fluoride varnish in the United States, the number of AEs reported to the US Food and Drug Administration were few. Thus fluoride varnish can be considered a safe dental product.
Practical Implications
Provides data on the safety of fluoride varnish that can be used by the dental profession to allay concerns by nondental providers and patients on this important caries preventive measure.
*Original article online at https://www.sciencedirect.com/science/article/pii/S0002817721000726
References
1. Hawkins R, Noble J, Locker D, et al. A comparison of the costs and patient acceptability of professionally applied topical fluoride foam and varnish. J Public Health Dent. 2004;64(2):106-110.
2. Marinho VCC, Worthington HV, Walsh T, Clarkson JE. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database Syst
Rev. 2013;7:CD002279.
3. Ramos-Gomez F. A model for community-based pediatric oral health: implementation of an infant oral care program. Int J Dent. 2014:156821.
4. Clark MB, Slayton RL. American Academy of Pediatrics, Section on Oral Health. Fluoride use in caries prevention in the primary care setting. Pediatrics. 2014; 134(3):626-633.
5. US Preventive Services Task Force. Dental caries in children from birth through age 5 years: screening. Rockville, MD: US Preventive Services Task Force; 2014.
6. Fluoride in drinking water: a scientific review of EPA’s standards. Subcommittee on health effects of ingested fluoride, Committee on Fluoride in Drinking Water, Board on Environmental Studies and Toxicology, Commission on Life Sciences, National Research Council. Washington, DC: National Academy Press; 2006.
7. Mascarenhas AK, Burt BA. Fluorosis risk from early exposure to fluoride toothpaste. Community Dent Oral Epidemiol. 1998;26:241-248.
8. Mascarenhas AK. Risk factors for dental fluorosis. Pediatr Dent. 2000;22:269-277.
9. Tiemann M. Fluoride in drinking water: a review of fluoridation and regulation issues. Available at: https://fas. org/sgp/crs/misc/RL33280.pdf . Accessed November 11, 2020.
10. Milgrom P, Taves DM, Kim AS, Watson GE, Horst JA. Pharmacokinetics of fluoride in toddlers after application of 5% sodium fluoride dental varnish. Pediatrics. 2014;134(3):e870-e874.
11. Garcia RI, Gregorich SE, Ramos-Gomez F, et al. Absence of fluoride varnisherelated adverse events in caries prevention trials in young children, United States. Prev Chronic Dis. 2017;14:160372.
12. MAUDE: Manufacturer and User Facility Device Experience database. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm . Accessed September 9, 2020.
13. Food and Drugs 21 C.F.R. §312.32 (2019). Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
cfrsearch.cfm?fr¼312.32 . Accessed September 9, 2020.
14. The Annie E. Casey Foundation. Child population by age group in the United States. Available at: https://datacenter.kidscount.org/data/tables/101-child-populationby-age-group#detailed/1/any/false/1729,37,871,870,573,
869,36,868,867,133/62,63,64,6,4693/419,420 . Accessed
September 9, 2020.
15. US Census Bureau. Annual estimates of the resident population by single year of age and sex: April 1, 2010 to July 1, 2019. Available at:
https://www.census.gov/data/tables/time-series/demo/popest/2010s-national-detail .
html#par_textimage_1537638156 . Accessed September 9,
2020.
16. US Department of Health and Human Services, Office of Disease Prevention and Health Promotion. Children, adolescents, and adults who visited the dentist in the past year (age adjusted, percent, 2þ years). Washington, DC: Healthy People; 2020. Available at:
https://www.healthypeople.gov/2020/data/Chart/5028?category¼4&by¼
Age%20group%20§&fips¼-1 . Accessed September 11, 2020.
17. American Academy of Pediatric Dentistry. Periodicity of examination, preventive dental services, anticipatory guidance/counseling, and oral treatment for infants, children, and adolescents. In: AAPD, ed. The Reference Manual of Pediatric Dentistry 2019-2020. Chicago, IL: AAPD; 2000:209-219.
18. Blackwell DL, Villarroel MA, Norris T. Regional variation in private dental coverage and care among dentate adults aged 18e64 in the United States, 2014
e2017. NCHS Data Brief. 2015;9(336):1-8.
19. Hebballi NB, Ramoni R, Kalenderian E, et al. The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database. JADA. 2015;146(2):102-110. 368 JADA
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