Medication safety during pregnancy and breastfeeding and effects on female and male fertility

Medication safety during pregnancy and breastfeeding and effects on female and male fertility

Medication Considerations During Pregnancy Breastfeeding and in Men

BreastfeedingMenOther Considerations
CorticosteroidsCompatible; optimally <20 mg/day; potential increased risk of oral cleft, preterm birth, and low birth weight at higher dosesCompatible; optimally wait 2 hours after dose to breastfeedLong-term use can be associated with decreased testosterone levelsDifficult to determine if risks during pregnancy are independent of maternal disease activity
MethotrexateContraindicated; teratogenicNot recommended; insufficient dataPossible/low risk of teratogenicity and reversible azoospermiaBefore planned pregnancy, discontinue at least 1 month in women and 3 months in men
LeflunomideContraindicated; teratogenic; if planning pregnancy, check blood level prior to ensure undetectable; if taking and unplanned pregnancy, administer cholestyramineNot recommended; insufficient dataInsufficient dataBefore planned pregnancy in women or men, discontinue 3.5 months to 2 years prior or consider cholestyramine
SulfasalazineCompatible; folate supplementation neededCompatibleReversible azoospermia that resolves 2–3 months after discontinuation
HydroxychloroquineCompatible; reduces risk of SLE flare in pregnancy; may improve pregnancy outcomes in SLECompatibleNo known risk
AzathioprineCompatible; crosses placenta but fetal liver lacks the enzyme to convert to the active metaboliteCompatibleLimited data but no known risk
Mycophenolate mofetilContraindicated; teratogenic; increased risk of first trimester pregnancy lossNot recommended; insufficient dataPossible teratogenicityBefore planned pregnancy, discontinue at least 6 weeks in women and 3 months in men
Antitumor necrosis factor α agentsCompatible; if pregnant and taking, consider discontinuation during third trimester when placental transfer occursCompatibleLimited data but no known riskCertolizumab has no active placental transfer
CyclophosphamideContraindicated; teratogenic; dose- and age-dependent infertility including premature ovarian failureContraindicatedDose-dependent infertility including irreversible azoospermiaIn men and women, consider waiting 6–12 months before planned pregnancy
Cyclosporine and tacrolimusCompatible; potential risk of preterm birth and low birth weight reported, but difficult to determine if risk is independent of other maternal factorsNot recommended; insufficient dataLimited data, but no known riskTacrolimus dose may need to be increased during pregnancy
Abatacept, rituximab, belimumab, anti-IL6, anti-IL17, and JAK inhibitorsNot recommended; insufficient dataInsufficient data, but antibodies probably safeInsufficient dataMost IgG molecules cross placenta in the second trimester and can therefore reach fetal circulation at that time
ColchicineCompatible; potential risk of preterm birth and low birth weight, but difficult to determine if risk is independent of other maternal factorsCompatibleLimited data, but no known riskNo need to hold in pregnant women with familial Mediterranean fever
Nonsteroidal antiinflammatory drugsRisk of miscarriage when used during the first trimester. Stop in third trimester to prevent premature closure of the fetal ductus arteriosusCompatibleSafe to use, but daily use, particularly for aspirin, could potentially reduce fertilityCould inhibit ovulation, consider avoiding days 8–20 of the menstrual cycle for planned pregnancy
ACEi/ARBContraindicated in second and third trimester due to fetal renal effectsNo known risk with enalapril and captopril; insufficient data for other ACEi/ARBsCompatibl

ACEi, Angiotensin-converting enzyme inhibitor; ARB, angiotensin-receptor blocker; IL, interleukin; JAK, Janus kinase; SLE, systemic lupus erythematosus.Compatible = low risk with no clear evidence of harm to fetus or infant.Any medication not clinically indicated or needed should be avoided in pregnancy, with the exception of hydroxychloroquine, which should be continued during pregnancy in lupus to reduce the risk of flare.Must always consider fetal risk of the medication versus fetal risk if disease flares.Although most medications in the chart have been detected in small amounts in breast milk, those listed as compatible have been used historically without safety concerns.Letter-based categories (i.e., A, B, C, D, and X) for medication risks in pregnancy and lactation are often confusing and not always clinically helpful. Therefore, in June 2015, the Food and Drug Administration implemented new Pregnancy and Lactation Labeling Rule that will phase out letter-based categories over the next several years.


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