PMID- 33766405
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 1943-4723 (Electronic)
IS  - 0002-8177 (Linking)
VI  - 152
IP  - 5
DP  - 2021 May
TI  - Is fluoride varnish safe?: Validating the safety of fluoride varnish.
PG  - 364-368
LID - S0002-8177(21)00072-6 [pii]
LID - 10.1016/j.adaj.2021.01.013 [doi]
AB  - 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.
CI  - Copyright (c) 2021. Published by Elsevier Inc.
FAU - Mascarenhas, Ana Karina
AU  - Mascarenhas AK
LA  - eng
PT  - Journal Article
DEP - 20210322
PL  - England
TA  - J Am Dent Assoc
JT  - Journal of the American Dental Association (1939)
JID - 7503060
RN  - 0 (Cariostatic Agents)
RN  - 0 (Fluorides, Topical)
RN  - Q80VPU408O (Fluorides)
SB  - IM
MH  - Cariostatic Agents
MH  - Child
MH  - *Dental Caries/prevention & control
MH  - Dental Cavity Lining
MH  - Fluorides
MH  - *Fluorides, Topical/adverse effects
MH  - Humans
MH  - Infant
MH  - United States
OTO - NOTNLM
OT  - Fluoride varnish
OT  - Manufacturer and User Facility Device Experience
OT  - US Food and Drug Administration
OT  - adverse events
OT  - safety
EDAT- 2021/03/27 06:00
MHDA- 2021/05/15 06:00
CRDT- 2021/03/26 05:59
PHST- 2020/10/01 00:00 [received]
PHST- 2021/01/21 00:00 [revised]
PHST- 2021/01/27 00:00 [accepted]
PHST- 2021/03/27 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2021/03/26 05:59 [entrez]
AID - S0002-8177(21)00072-6 [pii]
AID - 10.1016/j.adaj.2021.01.013 [doi]
PST - ppublish
SO  - J Am Dent Assoc. 2021 May;152(5):364-368. doi: 10.1016/j.adaj.2021.01.013. Epub 
      2021 Mar 22.