with oral clefts when administered during the first trimester of pregnancy (Bonner & Tyan, 1982; Park-Wyllie et al., 2000). For these reasons, the medications mentioned above are listed as pregnancy risk factor Category C or D by the FDA. The American Academy of Pediatrics (AAP), however, did report that use of these medications may be safe during breastfeeding – with the exception of aspirin, of which daily doses of more than 100 milligrams should be avoided because of the associated risk of platelet dysfunction and Reye syndrome (American Academy of Pediatrics Committee on Drugs, 2001). On the basis of the results of three large scale epidemiological studies, the safest analgesic for a pregnant patient is considered to be acetaminophen (known as paracetamol in Europe; Cleves et al., 2004; Källén & Otterblad, 2003; Park-Wyllie et al., 2000). The AAP also considers acetaminophen to be compatible with breastfeeding (American Academy of Pediatrics Committee on Drugs, 2001). Although low concentrations of acetaminophen are excreted into breast milk and can be detected in the urine of nursing infants, adverse reactions generally have not been observed; however, Matheson and colleagues (1985) reported that one breastfed infant developed a rash as a result of acetaminophen exposure. As mentioned, narcotics such as codeine, hydrocodone and oxycodone generally are not recommended as first-line drugs to treat dental pain, as they lack anti-inflammatory activity (Becker, 2010; Donaldson & Goodchild, 2010). If a practitioner does choose to prescribe one of these agents, codeine is considered the safest in regard to breastfeeding, according to the AAP (American Academy of Pediatrics Committee on Drugs, 2001), whereas hydrocodone and oxycodone carry a higher risk of causing sedation and
respiratory depression In the infant than codeine (Hendrickson & McKeown, 2012). Symptoms of opioid withdrawal also may occur after the cessation of breastfeeding (Madadi et al., 2009). Of these three drugs, oxycodone may be the safest; it is listed as Category B, and codeine and hydrocodone are listed as pregnancy risk factor Category C. However, the clinician must exercise caution if prescribing these drugs for prolonged periods or in high doses. In most cases, the risk to the infant is minimal, thus making it unnecessary for a mother receiving an opioid analgesic to discard breast milk (Hilton, 2012). Table 8 summarizes the recommendations for analgesic use in dental patients who are either pregnant or lactating (Donaldson & Goodchild, 2012). It should be noted that ibuprofen is representative of all NSAIDs in this table. COX-2 selective inhibitors such as celecoxib should be avoided in patients who are breastfeeding because of a scarcity of data, and doses of aspirin greater than 100 mg should also be avoided in this population because of the risk of platelet dysfunction and Reye’s syndrome. In the case of combination products (such as oxycodone with acetaminophen), the safety with respect to either pregnancy or breastfeeding is dependent on the highest risk moiety. In the example of oxycodone with acetaminophen, the combination of these two drugs should be used with caution, since the oxycodone moiety carries the higher risk in breastfeeding and possibly in pregnancy (American Academy of Pediatrics Committee on Drugs, 2001). Despite the pregnancy risk factor Category C rating for glucocorticoids in the dental patient who is pregnant, oral steroids should not be withheld in cases of acute severe asthma.
Table 8: U.S. Food and Drug Administration Information that will be in the Pregnancy and Lactation Labeling Rule (PLLR) Section for Pregnancy and Lactation General Information Risks Clinical Considerations Background Data Pregnancy Inclusion of statement on background risk. Contact information about scientifically acceptable pregnancy registries. • Fetal Risk Summary: Information from all relevant sources. • Statement on inadvertent exposure in early pregnancy or notation no data is available.
• Include study type, dose, duration, timing, and results including fetal abnormalities or other adverse effects. • Human data are presented first, including positive
• Risk conclusion regarding developmental abnormalities in humans and other relevant risks: whether likely drug increases risk or not. • If increased risk identified by human data, a narrative will be included. • If data demonstrate drug is not systemically absorbed, a statement is included that maternal use is not expected to result in fetal exposure. • When drug is systematically absorbed, statements of risk are divided based on type of data, human or animal, with findings from human studies presented first.
• Description of any known risk to woman or fetus from the untreated disease. • Dosing adjustments during pregnancy. • Maternal adverse effects of drug unique or increased during pregnancy. • Effects of dose, timing, and duration of treatment with drug during pregnancy. • Potential neonatal complications and interventions needed. • If drug potentially used during intrapartum, even if not an FDA-approved indication, information will be included about effects on woman, fetus, or newborn; duration of labor and birth; risk of complications including need for interventions and long-term potential effects on the child.
and negative effects, number of subjects, and study duration. includes species involved and recalculation of doses into human dose equivalents.
• Animal study
Page 174
Book Code: DHFL2624
EliteLearning.com/ Dental
Powered by FlippingBook