be aware of the maximum recommended doses of both the local anesthetic and vasoconstrictors shown in Tables 6 and 7. In most cases, limiting the total amount of epinephrine to 0.04 mg (the equivalent of two cartridges of 2% lidocaine with 1:100,000 The dental patient who is pregnant or breast-feeding The pregnant dental patient presents two significant challenges to the dental professional. First, although most dental procedures are elective and can be postponed until after the pregnancy is over, dental treatment for a pregnant woman who has oral pain, advanced disease, or infection present should not be delayed. Second, not all women of childbearing age know that they may be pregnant, and when selecting, prescribing, or administering a medication for any woman of childbearing age, the clinician always should consider the possibility of the patient being pregnant or conceiving while she still is receiving the medication. The aim when administering medication to a pregnant patient is to balance the risks of the drug’s potential adverse effects (usually on the fetus) with the benefit (usually to the mother) of treating the disease (Donaldson & Goodchild,
epinephrine or 4 cartridges of 4% articaine with 1:200,000 epinephrine) may be considered best practice in this population (Santos-Paul, Neves, Neves, & Ramires, 2015; Guimaraes, et al., 2021). 2012; U.S. Department of Health and Human Services [HHS], 2011). To reflect the dangers associated with the use of drugs in pregnancy, the U.S. Food and Drug Administration (FDA) has traditionally classified drugs on the basis of the level of risk they pose to the fetus (Table 8; HHS, 2011). Accordingly, drugs in categories A and B are considered safe for use in pregnancy, whereas drugs in category C may be used only if the benefits outweigh the risks. Use of drugs in category D should be avoided except in certain exceptional circumstances, and use of category X drugs in pregnant women is strictly prohibited. Although the FDA is phasing out the lettered system, many drugs will continue to show the letters on their labels for the next few years (American Society of Health- System Pharmacists, 2015; FDA, 2014).
Table 8: U.S. Food and Drug Administration Pregnancy Risk Factor Definitions Category Definition
A The results of controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of risk in later trimesters), and the possibility of fetal harm appears remote.
Either the results of animal reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women. OR the results of animal reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester and there is no evidence of risk in later trimesters. Either the results of studies in animals have revealed adverse effects (teratogenic, embryocidal or other) on the fetus and there are no controlled studies in women. OR results of studies in women and animals are not available; drug should be given only if the potential benefit justifies the potential risk to the fetus.
B
C
D There is positive evidence of human fetal risk, but the benefits of use in pregnant women may be acceptable despite the risk (for example, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). X Results of studies in animals or humans have demonstrated fetal abnormalities or evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit; use of the drug is contraindicated in women who are or may become pregnant. Note . Adapted from “Content and Format Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling,” by the U.S. Food and Drug Administration, 2014. Retrieve and-format-of-labeling-forhuman-prescription-drug-and-biological-products- requirements-for; “Drug Safety and Availability,” by the U.S. Food and Drug Administration, 2015a. Retrieved from http://www.fda.gov/Drugs/ Dr Requirements for Over-the-Counter Drugs,” by the U.S. Food and Drug Administration, 2015b. Retrieved from http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.80; “Pregnancy, Lactation, Products-Content and Format Draft Guidance for Industry,” by the U.S. Food and Drug Administration, 2020. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pregnancy-lactat
All local anesthetics can cross the placental barrier, primarily through passive diffusion. However, lidocaine with epinephrine and prilocaine may be considered the safest local anesthetics in this patient population because they are listed in the FDA’s traditional letter classification as pregnancy category B; there are no contraindications to their careful use in pregnant patients. Even above the maximum recommended dose, neither lidocaine nor prilocaine has shown evidence of fetal harm (California Dental Association Foundation; American College of Obstetricians and Gynecologists, District IX, 2010; Cengiz, 2007; Donaldson & Goodchild, 2012; Hilgers, Douglass, & Mathieu, 2003). Both of these local anesthetics are also considered compatible with breast-feeding according to the American Academy of Pediatrics (2001). Human case reports have shown fetal bradycardia to be a complication of administering bupivacaine and mepivacaine, while studies in rabbits have shown bupivacaine to be
embryocidal at five times the maximum recommended daily dose. One study found decreased survival in newborn rats when administered bupivacaine at nine times the maximum recommended daily dose. It may be considered a best practice to avoid the use of long-acting local anesthetics in this special population, to minimize the risk of fetal exposure and toxicity given the risk of increased free drug concentrations in pregnant women (Donaldson & Goodchild, 2012; Hilgers, et al., 2003). Articaine, bupivacaine, and mepivacaine may be considered less safe in pregnant patients compared to lidocaine and prilocaine, as they are all listed in the FDA’s traditional classification system as pregnancy category C. Although this class of drugs is generally considered compatible with breast-feeding according to the American Academy of Pediatrics (AAP; 2001), articaine remains the one exception and should be avoided. As mentioned previously, lidocaine with epinephrine is considered the safest local anesthetic in treating pregnant or
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