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AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women
and women of childbearing age without any proven increase in the frequency of malformations or
other direct or indirect harmful effects on the fetus having been observed.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule
for prescription drug products to require labeling that includes a summary of risk, a discussion of the
data supporting that summary, and relevant information to help health care providers make
prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy
categories A, B, C, D, and X are being phased out.
Risk Summary: There are no adequate and well-controlled data available on use of this drug in
pregnant women to inform of a drug-related risk.
Comment:
-Congenital syphilis prophylaxis: Reports suggest that this drug may not attain adequate fetal drug
concentrations to prevent congenital syphilis. Infants born to patients who were treated with oral
formulations of this drug for early syphilis should be given an appropriate penicillin regimen.
See references
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11/22/22, 10:58 AM Erythromycin Use During Pregnancy | Drugs.com
In a small trial (N=2), patients given 500 mg orally had milk levels of 1, 1.2, and 1.1 mg/L at 2, 4, and
6 hours after dosing, respectively. In a trial of patients (N=15) given 500 mg IV, breastmilk levels 2
hours after dosing were 2.5 mg/L.
There are case reports suggesting that a higher risk of IHPS may be associated with maternal
exposure within 7 weeks of delivery.
Caution is recommended.
Comments:
-The American Academy of Pediatrics (AAP) considers this drug compatible with breastfeeding.
-Some experts consider this drug compatible with breastfeeding; breastfed infants should be
monitored for irritability, infantile hypertrophic pyloric stenosis (IHPS) and effects on the
gastrointestinal flora (e.g., diarrhea, candidiasis [diaper rash, thrush]).
See references
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11/22/22, 10:58 AM Erythromycin Use During Pregnancy | Drugs.com
6. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization
"Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of
essential drugs. http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" (2014):
7. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health (2015):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to
your personal circumstances.
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