Nirmatrelvir/Ritonavir (Paxlovid®)

Selected References:

  • American College of Obstetricians and Gynecologists (ACOG). 2026. COVID-19 FAQs for obstetrician-gynecologists, obstetrics. https://www.acog.org/clinical-information/physician-faqs/covid-19-faqs-for-ob-gyns-obstetrics.  Accessed June 2026 
  • Anderson PO. 2022. COVID-19 drugs and breastfeeding update. Breastfeed Med; 17:377–9. 
  • Chourasia P, et al. 2023. Paxlovid (nirmatrelvir and ritonavir) use in pregnant and lactating woman: Current evidence and practice guidelines-a scoping review. Vaccines (Basel); 11:107.  
  • Chuang MT, et al. 2024. Transplacental passage of nirmatrelvir in pregnant women with COVID-19. Int J Gynaecol Obstet; 164(1):351-353.  
  • Corbett AH, al. 2014. Antiretroviral pharmacokinetics in mothers and breastfeeding infants from 6 to 24 weeks post-partum: Results of the BAN Study. Antivir Ther; 19:587–595.  
  • Dai J, et al. 2024. Low Nirmatrelvir and Ritonavir Exposure through Breastmilk: Analyzing Milk Concentrations and Infant Risk. Clin Pharmacol Ther; 116(5):1217-1221.  
  • Gandhi M, et al. 2013. Hair and plasma data show that lopinavir, ritonavir, and efavirenz all transfer from mother to infant in utero, but only efavirenz transfers via breastfeeding. J Acquir Immune Defic Syndr; 63:578-584.  
  • Garneau WM, et al. 2022. Analysis of clinical outcomes of pregnant patients treated with nirmatrelvir and ritonavir for acute SARS-CoV-2 infection. JAMA Netw Open; 5(11):e2244141. 
  • Lin CY, et al. 2023. Nirmatrelvir-ritonavir (Paxlovid) for mild coronavirus disease 2019 (COVID-19) in pregnancy and lactation. Obstet Gynecol; 141:957–60.  
  • Lin CW, et al. 2023. Clinical outcomes of nirmatrelvir-ritonavir use in pregnant women during the Omicron wave of the coronavirus disease 2019 pandemic. J Infect Public Health; 16(12):1942-1946. 
  • Loza A, et al. 2022. Short-term pregnancy outcomes after nirmatrelvir-ritonavir treatment for mild-to-moderate coronavirus disease 2019 (COVID-19). Obstet Gynecol; 140(3):447-449.  
  • Palombi L, et al. 2012. Antiretroviral prophylaxis for breastfeeding transmission in Malawi: drug concentrations, virological efficacy and safety. Antivir Ther; 17:1511–1519.  
  • Ramírez-Ramírez A, et al. 2018. Simultaneous quantification of four antiretroviral drugs in breast milk samples from HIV-positive women by an ultra-high performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method. PLoS One; 13:e0191236.  
  • Rezk NL, et al. 2008. Studies on antiretroviral drug concentrations in breast milk: Validation of a liquid chromatography-tandem mass spectrometric method for the determination of 7 anti-human immunodeficiency virus medications. Ther Drug Monit; 30:611–9.  
  • Yang H, et al. 2025. Birth Outcomes Following Anti-viral Therapy for Treatment of COVID-19 During Pregnancy. Matern Child Health J; 29(5):599-603.  


Nirmatrelvir/Ritonavir (Paxlovid®)

Selected References:

  • Campbell LS, et al. 2025. Balancing Mental Health and Breastfeeding: Evaluating the Transfer of Lurasidone Into Human Milk. J Clin Psychiatry; 86(4):25m15955. 
  • Cohen LS, et al. 2023. Reproductive safety of lurasidone and quetiapine: Update from the National Pregnancy Registry for Psychiatric Medications. J Womens Health (Larchmt); 32(4):452-462.  
  • Cruz MP. 2011. Lurasidone HCl (Latuda), an oral, once-daily atypical antipsychotic agent for the treatment of patients with schizophrenia. P & T: a peer-reviewed journal for formulary management; 36(8):489–492. 
  • Damkier, P & Videbech, P. 2018. The safety of second-generation antipsychotics during pregnancy: A clinically focused review. CNS Drugs; 32:351–366. 
  • FDA. 2011. FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns. Previously retrieved from  http://www.fda.gov/Drugs/DrugSafety/ucm243903.htm. 
  • Greenberg WM & Citrome L. 2017. Pharmacokinetics and pharmacodynamics of lurasidone hydrochloride, a second-generation antipsychotic: a systematic review of the published literature. Clin Pharmacokinet; 56:493–503. 
  • Kantrowitz JT, Citrome L. 2012. Lurasidone for schizophrenia: what’s different? Expert Rev Neurother; 12(3):265-73.  
  • Keightley P, et al. 2020. Lurasidone in lactation: A case study with laboratory and clinical outcomes. Aust N Z J Psychiatry; 54:1035–1036. 
  • Kernizan N, et al. 2024. Mood stabilizers for treatment of bipolar disorder in pregnancy and impact on neonatal outcomes. Bipolar Disord; 26(8):779-784.  
  • Kernizan N, et al. 2025. Prescribing Patterns for the Treatment of Bipolar Disorder in Pregnancy: A Retrospective Cohort Study. J Clin Med; 14(5):1638.  
  • Luo Z, et al. 2025. The safety analysis of lurasidone based on the real-world data of FAERS database. Expert Opin Drug Saf; 1-11.  
  • Montiel C, et al. 2022. Perinatal use of lurasidone for the treatment of bipolar disorder. Exp Clin Psychopharmacol; 30(2):249-252.  
  • Sumitomo Pharma America, Inc. (Last updated 2025). Latuda drug label. Source: National Library of Medicine. Available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afad3051-9df2-4c54-9684-e8262a133af8 
  • Terrana N, et al. 2015. Pregnancy outcomes following in utero exposure to second-generation antipsychotics: A systematic review and meta-analysis. Journal of Clinical Psychopharmacology; 35(5):559–565.  
  • Viguera AC, et al. 2022. Breastfeeding practices among women taking second-generation antipsychotics: Findings from the National Pregnancy Registry for Atypical Antipsychotics. Arch Womens Ment Health; 25:511–6.  
  • Wang E, et al. 2025. Comparative Safety of Antipsychotic Medications and Mood Stabilizers During Pregnancy: A Systematic Review and Network Meta-analysis of Congenital Malformations and Prenatal Outcomes. CNS Drugs; 39(1):1-22.  

 


Nirmatrelvir/Ritonavir (Paxlovid®)

Selected References:

  • Barr M Jr, Cohen MM Jr. 1991. ACE inhibitor fetopathy and hypocalvaria: the kidney-skull connection. Teratology; 44:485-495. 
  • Bhatt-Mehta V, Deluga KS. 1993. Fetal exposure to lisinopril: neonatal manifestations and management. Pharmacotherapy;13(5): 515-518. 
  • Burrows RF, Burrows EA. 1998. Assessing the teratogenic potential of angiotensin-converting enzyme inhibitors in pregnancy. Aust N Z J Obstet Gynaecol; 38(3):306-311. 
  • Chugh J, Dai J, Datta P, Krutsch K. 2025. Investigating the transfer of lisinopril into human milk: a quantitative analysis. J CardiovascPharmacol;85(1):4-87. 
  • Cooper WO, et al. 2006. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med; 354(23): 2443-2451.  
  • Diav-Citrin O, et al. 2011. Pregnancy outcome after in utero exposure to angiotensin converting enzyme inhibitors or angiotensin receptor blockers. Reprod Toxicol; 31(4):540-545. 
  • Filler G, et al. 2003. Early dialysis in a neonate with intrauterine lisinopril exposure. Arch Dis Child Fetal Neonatal Ed,88(2):F154-156.
  • Friedman JM. 2006. ACE inhibitors and congenital anomalies. NEnglJ Med, 354:2498-2500. 
  • Karthikeyan VJ, et al. 2011. Are angiotensin-converting enzyme inhibitors and angiotensin receptor blockers safe in pregnancy: a report of ninety-one pregnancies. J Hypertens, 29(2):396-399. 
  • Lennestal R, et al. 2009. Maternal use of antihypertensive drugs in early pregnancy and delivery outcome, notably the presence of congenital heart defects in the infants. Eur J Clin Pharmacol, 65(6):615-625. 
  • Lip GYH, et al. 1997. Angiotensin-converting-enzyme inhibitors in early pregnancy. Lancet, 350:1446-1447. 
  • Merck Sharp and Dohme Corp. 2018. Prinivil product label. Moretti ME, et al. 2012. The fetal safety of angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. Obstet Gynecol Int; 2012:658310.  
  • Moretti ME, et al. 2012. The fetal safety of angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. Obstet Gynecol Int2012:658310.  
  • National Collaborating Centre for Women’s and Children’s Health (UK). 2011. Hypertension in Pregnancy. Appendix O. Safety of commonly used antihypertensive drugs during breastfeeding. NICE ClinicalGuidelines, No. 107. London: RCOG Press. 
  • Polifka JE.2012.Is there an embryopathy associated with first-trimester exposure to angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists? A critical review of the evidence. Birth Defects Res (Part A), 94:576-598. 
  • Pryde PG, et al. 1993. Angiotensin-converting enzyme inhibitor fetopathy. J Am Soc Nephrol,3:1575-1582.
  • Rosa F, Bosco L. 1991. Infant renal failure with maternal ACE inhibition. Am JObstetGynecol, 161(1 Part 2):273 (abstract).  
  • Tomlinson AJ, et al. 2000. Malignant primary hypertension in pregnancy treated with lisinopril. Ann Pharmacother,34(2):180-182. 
  • U.S. Food and Drug Administration (FDA).1992.Upgraded warning on the use of ACE inhibitors during pregnancy. 
  • Yip SK, et al.1998. Exposure to angiotensin-converting enzyme inhibitors duringfirsttrimester: is it safe to fetus? Acta Obstet Gynecol Scand; 77:570-571. 


Nirmatrelvir/Ritonavir (Paxlovid®)

Selected References:

  • Atmaca M, Kuloglu M, Tezcan E, Canatan H, Gecici,O. 2002. Quetiapine is not associated with increase in prolactin secretion in contrast to haloperidol. Arch Med Res 33:562-5. 
  • Beumont PJ, Gelder MG, Friesen HG, et al. 1974. The effects of phenothiazine on endrocrine function: I Patients with inappropriate lactation and amenorrhoea. Br J Psychiatry. 124:413–9.  
  • Crawford AM, Beasley CM Jr, Tollefson GD. 1997. The acute and long-term effect of olanzapine compared with placebo and haloperidol on serum prolactin concentrations. Schizophr Res. 26:41–54.  
  • Cho H, et al. 2025. Antipsychotic use during pregnancy and outcomes in pregnant individuals and newborns. J Affect Disord. 373:495-504. 
  • Diav-Citrin O, Shechtman S, Ornoy S, et al. 2005. Safety of haloperidol and penfluridol in pregnancy: a multicenter, prospective, controlled study. Journal of Clinical Psychiatry 66:317-322. 
  • Dieulangard P et al. 1966. Sur un cas d’ectro-phocomelie peutetre d’origine medicamenteuse. Bull Fed Gynecol Obstet 18:85-87. 
  • Fiore L, Scapagnini U, Canonico PL. 1987. Effect of dihydroergocryptine and dihydroergocristine on cyclic AMP accumulation and prolactin release in vitro: Evidence for a dopaminomimetic action. Horm Res. 25:171–177.  
  • Kallen et al. 2013 The use of central nervous system active drugs during pregnancy. Pharmaceuticals 6(10):1221-1286. 
  • Kopelman AE et al. 1975. Limb malformations following maternal use of haloperidol. J Am Med Assoc 231:62-64. 
  • Langer G, Puhringer W. 1980. Haloperidol and droperidol treatment in schizophrenics. Clinical application of the «prolactin-model». Acta Psychiatr Belg. 80:574–83.  
  • Maguire GA. 2002. Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. J Clin Psychiatry. 63(suppl 4):56-62. 
  • Straub L, Hernández-Díaz S, Bateman BT, et al. 2022. Association of Antipsychotic Drug Exposure in Pregnancy With Risk of Neurodevelopmental Disorders: A National Birth Cohort Study. JAMA Intern Med. 182(5):522–533. 
  • Straub L, et al. 2026. Congenital malformation risk following prenatal antipsychotic exposure: a systematic safety surveillance approach. BMJ Ment Health. 29(1):e302270.  
  • Turkington RW. 1972. Prolactin secretion in patients treated with various drugs: Phenothiazines, tricyclic antidepressants, reserpine, and methyldopa. Arch Intern Med. 130:349–354.  
  • Turkington RW. 1972. Serum prolactin levels in patients with gynecomastia. J Clin Endocrinol Metab. 34:62–66.  
  • Uguz F. 2016. Breastfed infants exposed to combined antipsychotics: Two case reports. Am J Ther. 23:e1962–e1964 
  • Uguz F. 2019. Adverse events in a breastfed infant exposed to risperidone and haloperidol. Breastfeed Med. 14:683–684. 
  • Uguz F. 2021. A new safety scoring system for the use of psychotropic drugs during lactation. Am J Ther. 28:e118–e126 
  • Van Waes A, Van de Velde E. 1969. Safety evaluation of haloperidol in the treatment of hyperemesis gravidarum. J Clin Pharmacol 9:224-227. 
  • Wang, E., et al.. 2026. Correction: Comparative safety of antipsychotic medications and mood stabilizers during pregnancy: A systematic review and network meta-analysis of congenital malformations and prenatal outcomes. CNS Drugs 40, 841–863. 
  • Whalley LJ, Blain PG, Prime JK. 1981. Haloperidol secreted in breast milk. Br Med J (Clin Res Ed). 282:1746–1747. 
  • Yoshida K, Smith B, Craggs M, et al. 1997. Investigation of pharmacokinetics and possible adverse effects in infants exposed to tricyclic antidepressants in breast-milk. J Affect Disord. 43:225–237. 
  • Yoshida K, Smith B, Craggs M, et al. 1998. Neuroleptic drugs in breast-milk: A study of pharmacokinetics and of possible adverse effects in breast-fed infants. Psychol Med. 28:81–91. 


Nirmatrelvir/Ritonavir (Paxlovid®)

Selected References:

  • Asghar FA, et al. 2024. LTRA use in pregnancy: a systematic review on their safety and association with congenital anomalies’. JRGM, 13(2):1-8.   
  • Committee on Drugs. American Academy of Pediatrics. 2001. The transfer of drugs and other chemicals into human milk. Pediatrics. 108:776-789. 
  • Cossette B, et al. 2014. Relative perinatal safety of salmeterol vs formoterol and fluticasone vs budesonide use during pregnancy. Ann Allergy Asthma Immunol. 112(5):459-464. 
  • Eltonsy S, et al. 2011. Beta2-agonists use during pregnancy and the risk of congenital malformations. Birth Defects Research Clin Mol Teratol. 91(11):937-947. 
  • Gregersen TL, Ulrik CS. 2013. Safety of bronchodilators and corticosteroids for asthma during pregnancy: what we know and what we need to do better. J Asthma Allergy. 6:117-125. 
  • Lim A, et al. 2013. Asthma drugs in pregnancy and lactation. Aust Prescr. 36(5):150–153. 
  • Lim A, et al. 2011. Systematic review of the safety of regular preventive asthma medications during pregnancy. Ann Pharmacother. 45(7-8):931-945. 
  • Namazy J, Schatz M. 2018. Management of asthma during pregnancy: optimizing outcomes and minimizing risk. Semin Respir Crit Care Med. 39(01):29-35. 
  • National Asthma Education and Prevention Program. Working Group. 2004. Report on managing asthma during pregnancy: Recommendations for pharmacologic treatment. Update 2004. NIH publication NO.05-5236. Bethesda, MD: US Department of Health and Human Services; National Institutes of Health; National Heart, Lung and Blood Institute. 
  • Peterka M, ET AL. 2021. Anti-asthma Drugs Formoterol and Budesonide (Symbicort) Induce Orofacial Clefts, Gastroschisis and Heart Septum Defects in an In Vivo Model. In Vivo. 35(3):1451-1460.  
  • Tamasi L, et al. 2005. The management of bronchial asthma during pregnancy – Hungarian experiences. [Article in Hungarian] Orv Hetil. 146(45):2035-2039. 
  • Wilton LV, Shakir SA. 2002. A post-marketing surveillance study of formoterol (Foradil). Its use in general practice in England. Drug Saf. 25:213-223.