The use of compound topical anesthetics: a review.
BACKGROUND
The author reviewed the history of, federal regulations regarding, risks of and adverse drug reactions of five compound topical anesthetics: tetracaine, adrenaline/epinephrine and cocaine (TAC); lidocaine, adrenaline/epinephrine and tetracaine (LET); lidocaine, tetracaine and phenylephrine (TAC 20 percent Alternate); lidocaine, prilocaine and tetracaine (Profound); and lidocaine, prilocaine, tetracaine and phenylephrine with thickeners (Profound PET).


METHODS
The author reviewed clinical trials, case reports, descriptive articles, and U.S. Food and Drug Administration (FDA) regulations and recent public advisory warnings regarding the federal approval of and risks associated with the use of compound topical anesthetics.


RESULTS
Compound topical anesthetics are neither FDA-regulated nor -unregulated. Some compounding pharmacies bypass the new FDA drug approval process, which is based on reliable scientific data and ensures that a marketed drug is safe, effective, properly manufactured and accurately labeled. Two deaths have been attributed to the lay use of compound topical anesthetics. In response, the FDA has announced the strengthening of its efforts against unapproved drug products.


CONCLUSIONS
Compound topical anesthetics may be an effective alternative to local infiltration for some minimally invasive dental procedures; however, legitimate concerns exist in regard to their safety. Until they become federally regulated, compound topical anesthetics remain unapproved drug products whose benefits may not outweigh their risks for dental patients.
Kravitz
Neal D
ND
Department of Orthodontics, University of Illinois at Chicago College of Dentistry, USA. info@kravitzorthodontics.com
D000766:Anesthesia, Dental / Q000379:methods* / Q000706:statistics & numerical data; D000772:Anesthesia, Local / Q000379:methods* / Q000706:statistics & numerical data; D019162:Anesthetics, Combined / Q000009:adverse effects*; D000779:Anesthetics, Local / Q000009:adverse effects*; D000075202:Contraindications; D017277:Drug Approval; D004339:Drug Compounding; D004363:Drug Utilization / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D019162:Anesthetics, Combined; D000779:Anesthetics, Local