Medications may be required for various indications during pregnancy. The most commonly used medications include antiemetics, antacids, antihistamines, analgesics, antimicrobials, diuretics, antidepressants, and tranquilizers. Substance use and misuse is also common. Despite this trend, firm evidence-based guidelines for safe use of medications during pregnancy are still lacking.
Regulatory Information about Drug Safety During Pregnancy
Until the 2010s, the U.S. Food and Drug Administration (FDA) classified over-the-counter (OTC) and prescription drugs into 5 categories of safety for use during pregnancy (A, B, C, D, X). However, few well-controlled studies of therapeutic drugs have been done in pregnant women. Most information about drug safety during pregnancy is derived from animal studies, uncontrolled studies, and postmarketing surveillance. Consequently, the FDA classification system led to confusion and difficulty applying available information to clinical decisions. In December 2014, the FDA responded by requiring that the pregnancy categories A, B, C, D, and X be removed from the labeling of all drugs.
Instead of categories, the FDA now requires that drug labels provide information about the specific drug in a consistent format (called the final rule, or Pregnancy and Lactation Labeling (Drugs) Final Rule [PLLR]).
The information required by the FDA has 3 subsections:
Pregnancy: Information relevant to the use of the drug in pregnant women (eg, dosing, fetal risks) and information about whether there is a registry that collects and maintains data on how pregnant women are affected by the drug
Lactation: Information about using the drug while breastfeeding (eg, the amount of drug in breast milk, potential effects on the breastfed child)
Females and males of reproductive potential: Information about pregnancy testing, contraception, and infertility as it relates to the drug
The pregnancy and lactation subsections each include 3 subheadings (risk summary, clinical considerations, and data) that provide more detail. The final rule does not apply to nonprescription (over-the-counter) drugs.
Drug Transfer and Metabolism During Pregnancy
During pregnancy, medications are often required to treat certain disorders. In general, when potential benefit outweighs known risks, medications may be considered for treatment of disorders during pregnancy.
Not all medications or other substances in the maternal circulation cross the placenta (transfer) to the fetus. Some drugs that cross the placenta may have a direct toxic effect or a teratogenic effect. Drugs that do not cross the placenta may still harm the fetus by
Constricting placental vessels and thus impairing gas and nutrient exchange
Producing severe uterine hypertonia that results in anoxic injury
Altering maternal physiology (eg, causing hypotension)
For a list of some medications with adverse effects during pregnancy, see table Safety of Selected Drugs in Pregnancy.
Drugs diffuse across the placenta similarly to the way they cross other epithelial barriers (see Absorption). Whether and how quickly a drug crosses the placenta depend on the drug’s molecular weight, extent of its binding to another substance (eg, carrier protein), area available for exchange across the placental villi, and amount of drug metabolized by the placenta. Most drugs with a molecular weight of < 500 daltons readily cross the placenta and enter the fetal circulation. Substances with a high molecular weight (eg, protein-bound drugs) usually do not cross the placenta. One exception is immune globulin G, which may be used to treat disorders such as fetal alloimmune thrombocytopenia or fetal hemachromatosis. Generally, equilibration between maternal blood and fetal tissues takes at least 30 to 60 minutes; however, some drugs do not reach similar concentrations in the maternal and fetal circulation.
A drug’s effect on the fetus is determined largely by fetal age at exposure, placental permeability, maternal factors, drug potency, and drug dosage.
Fetal age affects the type of drug effect:
Before the 20th day after fertilization: Drugs given at this time typically have an all-or-nothing effect, killing the embryo or not affecting it at all. Teratogenesis is unlikely during this stage.
During organogenesis (between 20 and 56 days after fertilization): Teratogenesis is most likely at this stage. Drugs reaching the embryo during this stage may result in spontaneous abortion, a sublethal gross anatomic defect (true teratogenic effect), covert embryopathy (a permanent subtle metabolic or functional defect that may manifest later in life), or an increased risk of childhood cancer (eg, when the mother is given radioactive iodine to treat thyroid cancer); or the drugs may have no measurable effect.
After organogenesis (in the second and third trimesters): Teratogenesis is unlikely, but drugs may alter growth and function of normally formed fetal organs and tissues. As placental metabolism increases, doses must be higher for adverse fetal effects to occur.
Maternal factors include those that affect drug absorption, distribution, metabolism, and excretion. For example, nausea and vomiting may decrease absorption of an oral drug.
The overall rate of major structural birth defects in the United States is approximately 3% (1); most malformations result from genetic, environmental, multifactorial, or unknown causes. It is difficult to determine the overall rate of congenital malformations caused by therapeutic drugs. As an example, in one study of 5504 cases of birth defects, only 20% had a definite cause and < 1% of cases with known causes were due to medications (2).
Safety of Selected Drugs in Pregnancy
Examples | Adverse Effects | Comments |
|---|---|---|
Antibiotics | ||
Ototoxicity (eg, damage to fetal labyrinth), resulting in deafness | — | |
Gray baby syndrome In women or fetuses with G6PD deficiency, hemolysis | — | |
Possibly arthralgia; theoretically, musculoskeletal defects (eg, impaired bone growth), but no proof of this effect | — | |
In women or fetuses with G6PD deficiency, hemolysis | Contraindicated during the first trimester, at term (38 to 42 weeks), during labor and delivery, and just before onset of labor | |
In women or fetuses with G6PD deficiency, hemolysis | — | |
Ototoxicity | — | |
When given after about 34 weeks gestation, neonatal jaundice and, without treatment, kernicterus In women or fetuses with G6PD deficiency, hemolysis | — | |
Slowed bone growth, enamel hypoplasia, permanent yellowing of the teeth, and increased susceptibility to cavities in offspring Occasionally, liver failure in pregnant women | — | |
Increased risk of neural tube defects due to folate antagonism | Should be avoided during the first trimester | |
Anticoagulants | ||
Thrombocytopenia and maternal bleeding | Compatible with pregnancy; does not cross placenta | |
Thrombocytopenia and maternal bleeding | ||
Inadequate human data; possible harm to the fetus because these drugs appear to cross the placenta | No antidote for reversal; to be avoided during pregnancy | |
When given during the first trimester, fetal warfarin syndrome (eg, nasal hypoplasia, bone stippling, bilateral optic atrophy, various degrees of intellectual disability) When given during the second or third trimester, optic atrophy, cataracts, intellectual disability, microcephaly, microphthalmia, and fetal and maternal hemorrhage | Absolutely contraindicated during first trimester of pregnancy | |
Hemorrhagic disease of the newborn Risk of congenital malformations including neural tube defects | — | |
No appreciable increased risk with dosage up to 600 mg/day | Compatible with pregnancy | |
No adequate data available on fetal risks associated with use in pregnant women [1] | Caution is advised, with consideration of whether the benefits outweigh the potential risks and of alternative treatment options | |
Minor skeletal malformations in animal studies, but no appreciable increased risk in humans | Compatible with pregnancy | |
Hemorrhagic disease of the newborn Risk of congenital malformations | — | |
Congenital malformations (eg, cleft lip, genitourinary defects such as hypospadias, cardiovascular defects Hemorrhagic disease of the newborn | ||
Trimethadione | High risk of congenital malformations (eg, cleft palate; cardiac, craniofacial, hand, and abdominal defects) and risk of spontaneous abortion | Almost always contraindicated during pregnancy |
Valproate | Major congenital malformations (eg, neural tube defects such as meningomyelocele; cardiac, craniofacial, and limb defects) | |
Conflicting data on risk of congenital malformations from first trimester exposure | Dosing affected by hepatic or renal impairment | |
When given during the first trimester, increased risk of congenital malformations (particularly cardiac) When given during the third trimester, discontinuation syndrome and persistent pulmonary hypertension of the newborn | Consideration of dose tapering during the third trimester in consultation with a mental health professional | |
When given during the third trimester, discontinuation syndrome and persistent pulmonary hypertension of the newborn | Consideration of dose tapering during the third trimester in consultation with a mental health professional | |
When given during the third trimester, discontinuation syndrome and persistent pulmonary hypertension of the newborn | Long half-life; drug-drug interactions possibly occurring for weeks after the drug is stopped Consideration of dose tapering during the third trimester in consultation with a mental health professional | |
When given during the first trimester, increased risk of congenital malformations (particularly cardiac) When given during the third trimester, discontinuation syndrome and persistent pulmonary hypertension of the newborn | Use during pregnancy not recommended by some experts* Consideration of dose tapering during the third trimester in consultation with a mental health professional | |
When given during the third trimester, discontinuation syndrome and persistent pulmonary hypertension of the newborn | Consideration of dose tapering during the third trimester in consultation with a mental health professional | |
When given during the third trimester, discontinuation syndrome | Dosing greatly affected by hepatic or renal impairment Consideration of dose tapering during the third trimester in consultation with a mental health professional | |
Antiemetics | ||
No evidence of increased risk of congenital malformations | — | |
Abnormal muscle movements (extrapyramidal symptoms) or methemoglobinemia may potentially occur in neonates exposed during the third trimester and/or delivery [2] | Caution is advised, with consideration of whether the benefits outweigh the potential risks and of alternative treatment options | |
No significant teratogenic risk in animal studies When given during the first trimester, possible risk of congenital heart disease (evidence is weak) | Used during pregnancy only for hyperemesis gravidarum when other treatments are ineffective | |
No significant teratogenic risk in animal studies Generally no increased risk of congenital malformations Possibly decreased platelet aggregation in neonates | — | |
No significant teratogenic risk in animal studies | Monitoring recommended for systemic toxicities (electrolyte imbalance, renal dysfunction) in the mother | |
Teratogenic at high doses in animal studies No apparent increased risk of congenital malformations after a single dose of 150 mg/day After higher doses (> 400 mg/day) taken for most or all of the first trimester, increased risk of various malformations | — | |
With oral use, adverse effects in animal studies When applied to the skin, no significant risk of congenital malformations | Intravaginal use during the first trimester not shown to increase risk of congenital malformations | |
Adverse effects in animal studies No significant risk of congenital malformations | Intravaginal use during the first trimester not shown to increase risk of congenital malformations | |
Antihistamine/anticholinergic drugs | ||
Possible hypospadias (weak association) | — | |
Teratogenic in rodents, but no proof of this effect in humans | — | |
Chlorpropamide | Neonatal hypoglycemia | — |
Neonatal hypoglycemia Unknown long-term effects on fetus | Crosses the placenta | |
Neonatal hypoglycemia Unknown long-term effects on fetus | Crosses the placenta; generally considered safe in pregnancy | |
Tolbutamide | Neonatal hypoglycemia | — |
Antihypertensives | ||
When given during the second or third trimester, fetal hypocalvaria and hypoperfusion (which can cause renal defects), renal failure, and the oligohydramnios sequence (oligohydramnios, craniofacial deformities, limb contractures, and hypoplastic lung development) | — | |
Aldosterone antagonists | — | |
Beta-blockers [3] | — | |
Considered safe in pregnancy | ||
Prevention of normal maternal volume expansion, reducing placental perfusion and contributing to fetal growth restriction Neonatal hyponatremia, hypokalemia, and thrombocytopenia | — | |
Antineoplastic drugs‡ | ||
Actinomycin | Teratogenic in animals, but no proof of this effect in humans | — |
Congenital malformations (eg, fetal growth restriction, mandibular hypoplasia, cleft palate, cranial dysostosis, spinal defects, ear defects, clubfoot) | — | |
— | ||
No increased risk of major birth defects or pregnancy loss has been found with maternal use throughout pregnancy (including first trimester) for familial Mediterranean fever or other rheumatic diseases [6] | — | |
— | ||
Teratogenic in animals and humans Potential for dose-dependent cardiac dysfunction | Use during pregnancy not recommended Effective contraception recommended during pregnancy and for 6 months after treatment of male or female partner | |
Congenital malformations (eg, fetal growth restriction, mandibular hypoplasia, cleft palate, cranial dysostosis, spinal defects, ear defects, clubfoot) | — | |
Congenital malformations (eg, fetal growth restriction, mandibular hypoplasia, cleft palate, cranial dysostosis, spinal defects, ear defects, clubfoot) | Contraindicated during pregnancy except for ectopic pregnancy, which requires an initial and a follow-up visit to confirm a diagnosis of ectopic pregnancy to avoid harming the fetus if the pregnancy is intrauterine Effective contraception recommended for 8 weeks after the last dose | |
Teratogenic in animals, but no proof of this effect in humans | — | |
Teratogenic in animals, but no proof of this effect in humans | — | |
Antipsychotics and mood stabilizers | ||
When given during the third trimester, associated with a risk for abnormal muscle movements (extrapyramidal symptoms) and/or withdrawal symptoms in newborns [7] | Symptoms in the newborn may include agitation, feeding problems, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization | |
Adverse effects in animal studies When given during the first trimester, possibly limb malformations When given during the third trimester, increased risk of extrapyramidal symptoms or withdrawal symptoms in the neonate | — | |
No evidence of adverse effects in animal studies When given during the third trimester, increased risk of extrapyramidal symptoms or withdrawal symptoms in the neonate | — | |
Adverse effects in animal studies When given during the first trimester, teratogenic (cardiac malformations) When given later in pregnancy, lethargy, hypotonia, poor feeding, hypothyroidism, goiter, and nephrogenic diabetes insipidus in the neonate | — | |
Adverse effects in animal studies When given during the third trimester, increased risk of extrapyramidal symptoms or withdrawal symptoms in the neonate | — | |
Adverse effects in animal studies Based on limited data, no increased teratogenic risk When given during the third trimester, increased risk of extrapyramidal symptoms or withdrawal symptoms in the neonate | — | |
Anxiolytics | ||
When given late in pregnancy, respiratory depression or a neonatal withdrawal syndrome that can cause irritability, tremors, and hyperreflexia | — | |
Fetal kernicterus With high doses, possibly first-trimester spontaneous abortion, delayed onset of labor, premature closing of the fetal ductus arteriosus, jaundice, occasionally maternal (intrapartum and postpartum) and/or neonatal hemorrhage, necrotizing enterocolitis, and oligohydramnios | Use permitted for short durations during the second trimester if the fetus is carefully monitored | |
Does not appear to cause major malformations Use in second trimester may increase risk of oligohydramnios | — | |
Opioids and partial agonists | ||
Adverse effects but no teratogenicity in animal studies Risk of a neonatal opioid withdrawal syndrome (neonatal abstinence syndrome) | Improved fetal outcomes compared with those when pregnant women use illicit substances | |
In neonates of women addicted to opioids, withdrawal symptoms possibly occurring 6 hours to 8 days after birth With high doses given in the hour before delivery, possibly neonatal CNS depression and bradycardia | — | |
Adverse effects in animal studies Risk of a neonatal opioid withdrawal syndrome | Improved fetal outcomes compared with those when pregnant women use illicit substances Possible need for acute short-acting analgesics to supplement maintenance dosing during labor and delivery | |
Retinoids | ||
High teratogenic risk (eg, multiple congenital malformations), spontaneous abortion, and intellectual disability | Contraindicated during pregnancy and in patients who may become pregnant | |
Sex hormones | ||
When given during the first 14 weeks, masculinization of a female fetus’s genitals (eg, pseudohermaphroditism) | Contraindicated during pregnancy | |
Hormonal contraceptives | Exposure to estrogen-progestin contraceptives prior to conception or during pregnancy does not appear to be associated with an increased risk of major birth defects [8, 9] | No indication for use during pregnancy; should be discontinued |
When taken in second or third trimester, associated with an increased risk of gestational diabetes (weak association) [12] | Contraindicated during first trimester of pregnancy | |
Exposure during pregnancy not associated with increased risk of major birth defects [13] | — | |
Thyroid medications | ||
Preferred treatment of maternal hypothyroidism with established safety profile | — | |
Fetal goiter, facial dysmorphism,neonatal scalp defects (aplasia cutis), and other potential abnormalities | Contraindicated during first trimester of pregnancy | |
Fetal goiter and maternal hepatotoxicity and agranulocytosis | Typically used in the first trimester of pregnancy | |
Radioactive iodine (131I) | Destruction of the fetal thyroid gland or, when the drug is given near the end of the first trimester, severe fetal hyperthyroidism Increased risk of childhood cancer | Absolutely contraindicated during pregnancy |
Large fetal goiter, which may obstruct breathing in neonates | — | |
Triiodothyronine | Fetal goiter | Ultrasonography to monitor the fetus for potential goiter |
Vaccines [14] | ||
No safety concerns for pregnant people, or for fetuses or neonates, found in early data from safety monitoring systems [15] | — | |
No safety concerns for pregnant people or for fetuses or neonates [16] | — | |
Tetanus, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine | No safety concerns for pregnant people or for fetuses or neonates [17] | — |
Live-virus vaccines such as the measles, mumps, and rubella vaccine; polio vaccine; varicella vaccine; and | With rubella and varicella vaccines, potential infection of the placenta and developing fetus With other live vaccines, potential but unknown risks | Contraindicated in patients who are or may be pregnant |
Others | ||
Corticosteroids | When used during the first trimester, possibly orofacial clefts | — |
No increased risk at usual doses | May be started in the first trimester for risk reduction | |
Possible transient increases in maternal aminotransferase levels, peripheral neuropathy | Not to be used with other hepatotoxic drugs | |
Placental vasoconstriction and possible risk of gastroschisis | — | |
Use considered for pregnant patients with early mild to moderate COVID-19, particularly for patients with at least one additional risk factor for severe disease | ||
Congenital malformations | In the amount typically present in prenatal vitamins (5000 IU/day), no association with teratogenic risk, but possible risk with doses > 10,000 IU/day during early pregnancy | |
Vitamin K | In women or fetuses with G6PD deficiency, hemolysis | — |
‡ The European Society for Medical Oncology (ESMO) guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy advised that, generally, if chemotherapy is indicated, it should not be given during the first trimester but may begin during the second trimester; the last chemotherapy dose should be given ≥ 3 weeks before anticipated delivery, and chemotherapy should not be given after week 33 of gestation. Peccatori FA, Azim HA Jr, Orecchia R, et al: Cancer, pregnancy and fertility: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 24 Suppl 6:vi160-vi170, 2013. doi:10.1093/annonc/mdt199 | ||
1. Hoeltzenbein M, Slimi S, Fietz AK, et al. Increasing use of newer antiseizure medication during pregnancy: an observational study with special focus on lacosamide. Seizure 107:107-113, 2023. doi:10.1016/j.seizure.2023.02.015 2. Sun L, Xi Y, Wen X, Zou W: Use of metoclopramide in the first trimester and risk of major congenital malformations: a systematic review and meta-analysis. PLoS One 16(9):e0257584, 2021. Published 2021 Sep 20. doi:10.1371/journal.pone.0257584 3. Easterling T, Mundle S, Bracken H, et al: Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial. Lancet 394(10203):1011-1021, 2019. doi:10.1016/S0140-6736(19)31282-6 4. Bellos I, Pergialiotis V, Papapanagiotou A, et al: Comparative efficacy and safety of oral antihypertensive agents in pregnant women with chronic hypertension: a network metaanalysis. Am J Obstet Gynecol 223(4):525-537, 2020. doi:10.1016/j.ajog.2020.03.016 5. Sridharan K, Sequeira RP: Drugs for treating severe hypertension in pregnancy: a network meta-analysis and trial sequential analysis of randomized clinical trials. Br J Clin Pharmacol 84(9):1906-1916, 2018. doi:10.1111/bcp.13649 6. Indraratna PL, Virk S, Gurram D, Day RORheumatology (Oxford) 57(2):382-387, 2018. doi:10.1093/rheumatology/kex353 7. Larsen ER, Damkier P, Pedersen LH, et al: Use of psychotropic drugs during pregnancy and breast-feeding. Acta Psychiatr Scand Suppl 445:1-28, 2015. doi:10.1111/acps.12479 8. Charlton BM, Molgaard-Nielsen D, Svanstrom H, et al: Maternal use of oral contraceptives and risk of birth defects in Denmark: prospective, nationwide cohort study. BMJ 352:h6712, 2016. Published 2016 Jan 6. doi:10.1136/bmj.h6712 9. Waller DK, Gallaway MS, Taylor LG, et al: Use of oral contraceptives in pregnancy and major structural birth defects in offspring. Epidemiology 21(2):232-239, 2010. doi:10.1097/EDE.0b013e3181c9fbb3 10. Yovich JL, Turner SR, Draper R: Medroxyprogesterone acetate therapy in early pregnancy has no apparent fetal effects. Teratology 38(2):135-144, 1988. doi:10.1002/tera.1420380206 11. Carmichael SL, Shaw GM, Laurent C, et al: Maternal progestin intake and risk of hypospadias. Arch Pediatr Adolesc Med 159(10):957-962, 2005. doi:10.1001/archpedi.159.10.957 12. Pergialiotis V, Bellos I, Hatziagelaki E, et al: Progestogens for the prevention of preterm birth and risk of developing gestational diabetes mellitus: a meta-analysis. Am J Obstet Gynecol 221(5):429-436.e5, 2019. doi:10.1016/j.ajog.2019.05.033 13. O'Brien JM, Steichen JJ, Phillips JA, et al: 490: Two year infant outcomes for children exposed to supplemental intravaginal progesterone gel in utero: secondary analysis of a multicenter, randomized, double-blind, placebo-controlled trial, American Journal of Obstetrics and Gynecology, Volume 206, Issue 1, Supplement, 2012, Page S223, ISSN 0002-9378, https://doi.org/10.1016/j.ajog.2011.10.508 14. The American College of Obstetricians and Gynecologists (ACOG): Practice Advisory: Maternal immunization, October 2022. Accessed August 29, 2023. 15. ACOG: Practice Advisory: Vaccinating pregnant and lactating patients against COVID-19. December 2020. Accessed August 29, 2023. 16. ACOG: Committee Opinion No. 732: Influenza vaccination during pregnancy. Obstet Gynecol 131(4):e109-e114, 2018. doi:10.1097/AOG.0000000000002588 17. ACOG: Committee Opinion No. 718: Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination. Obstet Gynecol 130(3):e153-e157, 2017. doi:10.1097/AOG.0000000000002301 | ||
ACE = angiotensin-converting enzyme; ACIP = Advisory Committee on Immunization Practices; CDC = Centers for Disease Control and Prevention; CNS = central nervous system; G6PD = glucose-6-phosphate dehydrogenase; OB/GYN = obstetrics and gynecology. | ||
Vaccines During Pregnancy
Immunization is as effective in women who are pregnant as in those who are not.
Influenza vaccine is recommended for all pregnant women during influenza season.
The tetanus-diphtheria-pertussis (Tdap) vaccine is recommended for all pregnant women during the third trimester.
The CDC recommends COVID-19 vaccination for all people 5 years and older, including people who are pregnant, breastfeeding, trying to get pregnant, or might become pregnant in the future. Evidence about the safety and effectiveness of COVID-19 vaccination during pregnancy has been growing. These data suggest that the benefits of receiving a COVID-19 vaccine outweigh any known or potential risks of vaccination during pregnancy. (See also CDC: COVID-19 Vaccines While Pregnant or Breastfeeding.)
In August 2023, the US Food and Drug Administration approved use of a respiratory syncytial virus (RSV) vaccine in pregnant individuals between 32 to 36 weeks of gestation, with a warning to avoid use prior to 32 weeks. Clinical trials have found increased rates of preterm birth, preeclampsia in pregnant patients, and low birth weight and jaundice in infants following prenatal administration of RSV vaccine versus placebo; further study is needed to evaluate these potential risks (3).
Other vaccines should be reserved for situations in which the woman or fetus is at significant risk of exposure to a hazardous infection and risk of adverse effects from the vaccine is low. Vaccinations for cholera, hepatitis A, hepatitis B, measles, mumps, plague, poliomyelitis, rabies, typhoid, and yellow fever may be given during pregnancy if risk of infection is substantial.
Live-virus vaccines should not be given to women who are or may be pregnant. Rubella vaccine, an attenuated live-virus vaccine, may cause subclinical placental and fetal infection. However, no defects in neonates have been attributed to rubella vaccine, and women vaccinated inadvertently during early pregnancy need not be advised to terminate pregnancy based solely on theoretical risk from the vaccine. Varicella vaccine is another attenuated live-virus vaccine that can potentially infect the fetus; risk is highest between 13 weeks and 22 weeks gestation. This vaccine is contraindicated during pregnancy.
Antidepressants During Pregnancy
Antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), are commonly used during pregnancy because the prevalence of clinical depression during pregnancy is high (7 to 12% in one review) (6). Physiologic and psychosocial changes during pregnancy can affect depression (possibly worsening it) and possibly reduce the response to antidepressants. Ideally, a multidisciplinary team that includes an obstetrician and a psychiatric specialist should manage depression during pregnancy.
Pregnant women who are taking antidepressants should be asked about depressive symptoms at each prenatal visit, and appropriate fetal testing should be done. It may include the following:
A detailed evaluation of fetal anatomy during the second trimester
To reduce the risk of withdrawal symptoms in the neonate, clinicians should consider tapering the dose of all antidepressants to the lowest effective dose during the third trimester. However, the benefits of tapering must be carefully balanced against the risk of symptom recurrence and postpartum depression. Postpartum depression is common, often unrecognized, and should be treated promptly. Periodic visits with a psychiatrist and/or social workers may be helpful.
References
1. Centers for Disease Control and Prevention (CDC): Update on overall prevalence of major birth defects--Atlanta, Georgia, 1978-2005. MMWR Morb Mortal Wkly Rep 57(1):1-5, 2008.
2. Feldkamp ML, Carey JC, Byrne JLB, Krikov S, Botto LD: Etiology and clinical presentation of birth defects: population based study. BMJ 357:j2249, 2017. Published 2017 May 30. doi:10.1136/bmj.j2249
3. U.S. Food and Drug Administration (FDA): FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants. FDA News Release, August 21, 2023.
4. Garneau WM, Jones-Beatty K, Ufua MO, et al: Analysis of clinical outcomes of pregnant patients treated with nirmatrelvir and ritonavir for acute SARS-CoV-2 infection. JAMA Netw Open 5(11):e2244141, 2022. Published 2022 Nov 1. doi:10.1001/jamanetworkopen.2022.44141
5. Liggins GC, Howie RN: A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics 50(4):515-525, 1972.
6. Bennett HA, Einarson A, Taddio A, et al: Prevalence of depression during pregnancy: systematic review [published correction appears in Obstet Gynecol 103(6):1344, 2004]. Obstet Gynecol 103(4):698-709, 2004. doi:10.1097/01.AOG.0000116689.75396.5f
More Information
The FDA's Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling: This document discusses the change in labeling for pregnancy, which eliminates the pregnancy categories (A, B, C, D, X) and replaces them with more helpful and detailed information. The new labeling requires a summary of the risks of drug use during pregnancy and lactation, data to support that summary, and relevant information to help health care professionals make prescribing decisions and advise women about drug use during pregnancy and lactation.
Teratogen Information System: This web site provides resources to help clinicians determine the risks of drugs (and of environmental exposures [eg, vaccines, infections]) during pregnancy. It provides expert information about > 1700 drugs (including 200 of the most frequently prescribed drugs). Clinical and experimental literature is summarized, and based on that information, teratogenic risk is assigned. A subscription is required.
