Longer courses (seven days) cured more than 90% of women, whereas standard (four-day) courses cured only about 50% of the affected women (Soong & Einarson, 2009). Newer oral agents such as fluconazole provide for equally efficacious, short-course treatment (from a single 150 mg dose up to a once- daily, three-day course) and may be preferred for compliance reasons. Fluconazole is listed as pregnancy risk factor Category C by the FDA for the single-dose vaginal candidiasis regimen and pregnancy risk factor Category D for all other indications. Regardless, the investigators in a 2008 trial in Denmark who examined the maternal use of fluconazole and risk of congenital malformations found no overall increased risk of congenital malformations after fetal exposure to short-course treatment with fluconazole in early pregnancy (Nørgaard et al., 2008). The AAP considers fluconazole safe in regard to breastfeeding.
Table 10 summarizes the recommendations for antibiotic use in the dental patient who is pregnant or breastfeeding. It should be noted that patients who are pregnant should receive the full adult dose of medication and for the usual length of treatment. Serious infections should be treated aggressively. Penicillins and cephalosporins are considered safe, and the use of higher dose regimens (such as cephalexin 500 mg three times per day rather than 250 mg three times per day) should be elected, as these β -lactam antibiotics are cleared from the system more quickly because of the increase in glomerular filtration rate in pregnancy. In the patient who is breastfeeding, antibiotics may cause altered bowel flora and, thus, cause diarrhea in the baby. If the infant develops a fever, the clinician should take into account maternal antibiotic treatment.
Table 10: Key Medication Considerations During Pregnancy and Breastfeeding Medication FDA Risk Category Safe During Pregnancy?
Safe During Breastfeeding?
Amoxicillin
B
Yes
Yes
Azithromycin
B
Yes
Yes
Cephalexin
B
Yes
Yes
Chlorhexidine (topical)
B
Yes
Yes
Clarithromycin
C
Use with caution
Use with caution
Clindamycin
B
Yes
Yes
Clotrimazole (topical)
B
Yes
Yes
Doxycycline
D
Avoid
Avoid
Erythromycin
B
Yes
Use with caution
Fluconazole
C/D
Yes (single-dose regimens)
Yes
Metronidazole
B
Yes
Avoid; may give breast milk an unpleasant taste
Nystatin
C
Yes
Yes
Penicillin
B
Yes
Yes
Terconazole (topical)
B
Yes
Yes
Tetracycline
D
Avoid
Avoid
In 2015 the FDA replaced the former pregnancy risk letter categories on prescription and biological drug labeling with new information to make them more meaningful to both patients and healthcare providers (Brucker & King, 2017). The old five-letter system left patients and providers ill- informed and resulted in false assumptions about the actual meaning of the letters. The new labeling system allows better patient-specific counseling and informed decision making for pregnant women seeking medication therapies. While the new labeling improves the old format, it still does not provide a definitive “yes” or
“no” answer in most cases. Also, the Pregnancy and Lactation Labeling Final Rule (PLLR) went into effect on June 30, 2015 yet the timelines for implementing this new information on drug labels (also known as the package insert ) is still variable. Clinical interpretation is still required on a case-by-case basis, and for this reason most practitioners continue to rely on the traditional five-letter system. The A, B, C, D and X risk categories, in use since 1979, are now replaced with narrative sections and subsections as shown in Table 11 (U.S. Food and Drug Administration, 2016).
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