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FDA Rules for Pregnancy and Lactation Labeling and Their Clinical Implications

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Women's Mental Health

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Abstract

The new Food and Drug Administration (FDA) system for the use of drugs in pregnancy and lactation came into effect in 2015. The label content and format were reformulated, and any references to categories A, B, C, D, and X were removed and replaced by a summary of the perinatal risks of the substance, a discussion about the scientific data, and a synthesis of its relevance for medical treatment. The ultimate goal of the new standards is to facilitate the prescribing process by offering a consistent and well-structured set of information regarding the use of medications during pregnancy and lactation. The prior FDA category system had unintended effects on the perception and use of psychotropic medications in pregnancy and breastfeeding and contributed to a widespread overemphasis on the risks of these medications alongside a failure to appreciate the risks of untreated mental illness for women and babies. The clincial effect of the old categories in combination with stigma and lack of well designed research was likely the undertreatment of severe mental illness in pregnancy. The new FDA narrative summaries attempt to remedy these errors but require a high degree of medical knowledge about reproductive psychiatry and the evidence-based literature on the part of physcians and other providers. Specific medical training in the treatment of pregnant women with mental illness is a pressing need.

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References

  1. Freeman MP. Pregnancy and psychiatric disorders: inherent risks and treatment decisions. J Clin Psychiatry. 2013;74(4):373–4. https://doi.org/10.4088/JCP.13f08356.

    Article  PubMed  Google Scholar 

  2. Ramoz LL, Patel-Shori NM. Recent changes in pregnancy and lactation labeling: retirement of risk categories. Pharmacotherapy. 2014;34(4):389–95. https://doi.org/10.1002/phar.1385.

    Article  PubMed  Google Scholar 

  3. Källén B, Borg N, Reis M. The use of central nervous system active drugs during pregnancy. Pharmaceuticals (Basel). 2013;6(10):1221–86. https://doi.org/10.3390/ph6101221.

    Article  CAS  Google Scholar 

  4. Pearlstein T. Use of psychotropic medication during pregnancy and the postpartum period. Women’s Health (Lond Engl). 2013;9(6):605–15. https://doi.org/10.2217/whe.13.54.

    Article  CAS  Google Scholar 

  5. Ray S, Stowe ZN. The use of antidepressant medication in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2014;28(1):71–83. https://doi.org/10.1016/j.bpobgyn.2013.09.005.

    Article  PubMed  Google Scholar 

  6. Koren G, Madjunkova S, Maltepe C. Bias against the null hypothesis: scaring pregnant women about drugs in pregnancy. Can Fam Physician. 2014;60:441–2. Available from: http://www.cfp.ca/content/cfp/60/5/441.full.pdf.

    PubMed  PubMed Central  Google Scholar 

  7. Mitchell AA, Gilboa SM, Werler MM, et al. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol. 2011;205(1):51.e1–8. https://doi.org/10.1016/j.ajog.2011.02.029.

    Article  Google Scholar 

  8. Food and Drug Administration, HHS. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Final rule. Fed Regist. 2014;79(233):72063–103.

    Google Scholar 

  9. Tronnes JN, Lupattelli A, Nordeng H. Safety profile of medication used during pregnancy: results of a multinational european study. Pharmacoepidemiol Drug Saf. 2017;26(7):802–11. https://doi.org/10.1002/pds.4213.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Addis A, Sharabi S, Bonati M. Risk classification systems for drug use during pregnancy: are they a reliable source of information? Drug Saf. 2000;23(3):245–53.

    Article  CAS  PubMed  Google Scholar 

  11. Doering PL, Boothby LA, Cheok M. Review of pregnancy labeling of prescription drugs: is the current system adequate to inform of risks? Am J Obstet Gynecol. 2002;187(2):333–9. https://doi.org/10.1067/mob.2002.125740.

    Article  PubMed  Google Scholar 

  12. Cohen L. Limitations of pregnancy risk categories. https://womensmentalhealth.org/mcm_obgyn/limitations-of-pregnancy-risk-categories/. Updated 2001. Accessed 08/03, 2017.

  13. Law R, Bozzo P, Koren G, Einarson A. FDA pregnancy risk categories and the CPS: do they help or are they a hindrance? Can Fam Physician. 2010;56(3):239–41.

    Google Scholar 

  14. Ward RK, Zamorski MA. Benefits and risks of psychiatric medications during pregnancy. Am Fam Physician. 2002;66(4):629–36.

    PubMed  Google Scholar 

  15. Scialli AR, Buelke-Sam JL, Chambers CD, et al. Communicating risks during pregnancy: a workshop on the use of data from animal developmental toxicity studies in pregnancy labels for drugs. Birth Defects Res A Clin Mol Teratol. 2004;70(1):7–12. https://doi.org/10.1002/bdra.10150.

    Article  CAS  PubMed  Google Scholar 

  16. O’Connor E, Rossom RC, Henninger M, et al. FDA antidepressant drug labels for pregnant and postpartum women – screening for depression in adults: An updated systematic evidence review for the U.S. preventive services task force [internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Jan. (Evidence Syntheses, No. 128.) Appendix A, FDA Antidepressant Drug Labels for Pregnant and Postpartum Women. Available from: https://www.ncbi.nlm.nih.gov/books/NBK349032/. 2016:08/03/17.

  17. Friedman JM. Report of the teratology society public affairs committee symposium on FDA classification of drugs. Teratology. 1993;48(1):5–6. https://doi.org/10.1002/tera.1420480103.

    Article  CAS  PubMed  Google Scholar 

  18. Czeizel AE. Recommendation to avoid all drugs during first trimester is unrealistic. BMJ. 1996;313(7054):424–5.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Public Affairs Committee of the Teratology Society. Teratology public affairs committee position paper: pregnancy labeling for prescription drugs: ten years later. Birth Defects Res A Clin Mol Teratol. 2007;79(9):627–30. https://doi.org/10.1002/bdra.20389.

    Article  CAS  Google Scholar 

  20. Gendron MP, Martin B, Oraichi D, Berard A. Health care providers’ requests to teratogen information services on medication use during pregnancy and lactation. Eur J Clin Pharmacol. 2009;65(5):523–31. https://doi.org/10.1007/s00228-008-0611-6.

    Article  PubMed  Google Scholar 

  21. Einarson A, Park A, Koren G. How physicians perceive and utilize information from a teratogen information service: the motherisk program. BMC Med Educ. 2004;4:6. https://doi.org/10.1186/1472-6920-4-6.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Einarson A, Portnoi G, Koren G. Update on motherisk updates. Seven years of questions and answers. Can Fam Physician. 2002;48:1301–4.

    PubMed  PubMed Central  Google Scholar 

  23. Ram D, Gowdappa B, Ashoka HG, Eiman N. Psychopharmacoteratophobia: excessive fear of malformation associated with prescribing psychotropic drugs during pregnancy: an indian perspective. Indian J Pharmacol. 2015;47(5):484–90. https://doi.org/10.4103/0253-7613.165186.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Cantilino A, Lorenzo L, Paula Jdos A, Einarson A. Use of psychotropic medications during pregnancy: perception of teratogenic risk among physicians in two latin american countries. Rev Bras Psiquiatr. 2014;36(2):106–10.

    Article  PubMed  Google Scholar 

  25. Gils C, Pottegard A, Ennis ZN, Damkier P. Perception of drug teratogenicity among general practitioners and specialists in obstetrics/gynecology: a regional and national questionnaire-based survey. BMC Pregnancy Childbirth. 2016;16:226–016-1025-6. https://doi.org/10.1186/s12884-016-1025-6.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Osborne LM, Payne J. Antidepressants, pregnancy, and stigma: how we are failing mothers and babies. J Nerv Ment Dis. 2015;203(3):164–6. https://doi.org/10.1097/NMD.0000000000000257.

    Article  PubMed  Google Scholar 

  27. Andrade SE, Raebel MA, Brown J, et al. Use of antidepressant medications during pregnancy: a multisite study. Am J Obstet Gynecol. 2008;198(2):194.e1–5.

    Article  Google Scholar 

  28. Urato AC. Are the SSRI antidepressants safe in pregnancy? Understanding the debate. Int J Risk Saf Med. 2015;27(2):93–9. https://doi.org/10.3233/JRS-150646.

    Article  PubMed  Google Scholar 

  29. Smyth C. Pregnant women warned over risks of antidepressants. Times Newspapers, London. 2012. p. 28.

    Google Scholar 

  30. Baird KL. The new NIH and FDA medical research policies: targeting gender, promoting justice. J Health Polit Policy Law. 1999;24(3):531–65.

    Article  CAS  PubMed  Google Scholar 

  31. Yonkers KA, Wisner KL, Stewart DE, et al. The management of depression during pregnancy: a report from the american psychiatric association and the american college of obstetricians and gynecologists. Obstet Gynecol. 2009;114(3):703–13. https://doi.org/10.1097/AOG.0b013e3181ba0632.

    Article  PubMed Central  Google Scholar 

  32. Yonkers KA, Blackwell KA, Glover J, Forray A. Antidepressant use in pregnant and postpartum women. Annu Rev Clin Psychol. 2014;10:369–92. https://doi.org/10.1146/annurev-clinpsy-032813-153626.

    Article  PubMed  Google Scholar 

  33. Wang SS. Therapy preferred to drugs for depression in pregnancy. Wall Street J – Eastern Edition. 2009;254(44):A5.

    Google Scholar 

  34. Wilson C. Pregnancy dilemma: antidepressants and depression may both harm a fetus. New Sci. 2009;204(2731):12.

    Article  Google Scholar 

  35. Effexor birth defects. http://www.birthinjuryguide.org/birth-injury/causes/medication/effexor/. Accessed 08/10, 2017.

  36. Gibb G. With paxil an FDA category D, will other antidepressants follow? https://www.lawyersandsettlements.com/articles/paxil-heart-defects-newborn/paxil-side-effects-lawsuit-birth-defects-32-15966.html. Accessed 08/09, 2017.

  37. Cohen LS, Altshuler LL, Harlow BL, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295(5):499–507.

    Article  CAS  PubMed  Google Scholar 

  38. Viguera AC, Whitfield T, Baldessarini RJ, et al. Risk of recurrence in women with bipolar disorder during pregnancy: prospective study of mood stabilizer discontinuation. Am J Psychiatry. 2007;164(12):1817–24; quiz 1923.

    Article  Google Scholar 

  39. Zuckerman B, Amaro H, Bauchner H, Cabral H. Depressive symptoms during pregnancy: relationship to poor health behaviors. Am J Obstet Gynecol. 1989;160(5 Pt 1):1107–11.

    Article  CAS  PubMed  Google Scholar 

  40. Ross LE, Grigoriadis S. Selected pregnancy and delivery outcomes after exposure to antidepressant medication. JAMA Psychiat. 2014;71(6):716–7. https://doi.org/10.1001/jamapsychiatry.2014.59.

    Article  Google Scholar 

  41. Rotem-Kohavi N, Oberlander TF. Variations in neurodevelopmental outcomes in children with prenatal SSRI antidepressant exposure. Birth Defects Res. 2017;109(12):909–23. https://doi.org/10.1002/bdr2.1076.

    Article  CAS  PubMed  Google Scholar 

  42. Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003;6(4):263–74. https://doi.org/10.1007/s00737-003-0024-6.

    Article  CAS  PubMed  Google Scholar 

  43. O’Connor TG, Heron J, Golding J, Glover V, ALSPAC Study Team. Maternal antenatal anxiety and behavioural/emotional problems in children: a test of a programming hypothesis. J Child Psychol Psychiatry. 2003;44(7):1025–36.

    Article  PubMed  Google Scholar 

  44. O’Connor TG, Heron J, Golding J, Beveridge M, Glover V. Maternal antenatal anxiety and children’s behavioural/emotional problems at 4 years. Report from the avon longitudinal study of parents and children. Br J Psychiatry. 2002;180:502–8.

    Article  PubMed  Google Scholar 

  45. Koren G. The way women perceive teratogenic risk. Can J Clin Pharmacol. 2007;14(1):e10–6.

    PubMed  Google Scholar 

  46. Bonari L, Koren G, Einarson TR, Jasper JD, Taddio A, Einarson A. Use of antidepressants by pregnant women: evaluation of perception of risk, efficacy of evidence based counseling and determinants of decision making. Arch Womens Ment Health. 2005;8(4):214–20. https://doi.org/10.1007/s00737-005-0094-8.

    Article  CAS  PubMed  Google Scholar 

  47. Dolman C, Jones IR, Howard LM. Women with bipolar disorder and pregnancy: factors influencing their decision-making. BJPsych Open. 2016;2(5):294–300. https://doi.org/10.1192/bjpo.bp.116.003079.

    Article  PubMed  PubMed Central  Google Scholar 

  48. Walton GD, Ross LE, Stewart DE, Grigoriadis S, Dennis CL, Vigod S. Decisional conflict among women considering antidepressant medication use in pregnancy. Arch Womens Ment Health. 2014;17(6):493–501. https://doi.org/10.1007/s00737-014-0448-1.

    Article  PubMed  Google Scholar 

  49. Einarson A, Selby P, Koren G. Abrupt discontinuation of psychotropic drugs during pregnancy: fear of teratogenic risk and impact of counselling. J Psychiatry Neurosci. 2001;26(1):44–8.

    CAS  PubMed  PubMed Central  Google Scholar 

  50. Stahl SM. Stahl’s essential psychopharmacology: Neuroscientific basis and practical application. 6th ed. Cambridge: Cambridge University Press; 2017. p. 608.

    Google Scholar 

  51. Langan R, Goodbred AJ. Identification and management of peripartum depression. Am Fam Physician. 2016;93(10):852–8.

    Google Scholar 

  52. Grigoriadis S, Vonderporten EH, Mamisashvili L, et al. Prenatal exposure to antidepressants and persistent pulmonary hypertension of the newborn: systematic review and meta-analysis. BMJ. 2014;348:f6932. https://doi.org/10.1136/bmj.f6932.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  53. CDC. Treating for two. https://www.cdc.gov/pregnancy/meds/treatingfortwo/research.html. Accessed 20 Nov 2017.

  54. Solomon A. The secret sadness of pregnancy with depression. The New York times, New York magazine. 2015.

    Google Scholar 

  55. ACGME program requirements for graduate medical education in psychiatry. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/400_psychiatry_2016.pdf. Accessed 06 June 2017.

  56. Osborne LM, MacLean JV, Barzilay EM, Meltzer-Brody S, Miller L, Yang SN. Reproductive psychiatry residency training: a survey of psychiatric residency program directors. Acad Psychiatry. 2017; https://doi.org/10.1007/s40596-017-0672-x.

    Article  PubMed  Google Scholar 

  57. Nagle-Yang S, Miller L, Osborne LM. Reproductive psychiatry fellowship training: identification and characterization of current programs. Acad Psychiatry. 2017; https://doi.org/10.1007/s40596-017-0690-8.

    Article  PubMed  Google Scholar 

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Author information

Authors and Affiliations

  1. Women’s Mood Disorders Center, The Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Lauren M. Osborne

  2. Division of Consultation-Liaison, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA

    Nicole Leistikow

  3. Private Practice, São Lucas Medical Institute Criciúma, Santa Catarina, Brazil

    Renan Rocha

Authors
  1. Lauren M. Osborne
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  2. Nicole Leistikow
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  3. Renan Rocha
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Corresponding author

Correspondence to Lauren M. Osborne .

Editor information

Editors and Affiliations

  1. University of São Paulo, São Paulo, Brazil

    Joel Rennó Jr.

  2. Women’s Mental Health Clinic, Incestuous Families Treatment Clinic of Clinica’s Hospital, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

    Gislene Valadares

  3. Federal University of Pernambuco, Recife, Pernambuco, Brazil

    Amaury Cantilino

  4. Brazilian Association of Psychiatry, Rio de Janeiro, Brazil

    Jeronimo Mendes-Ribeiro

  5. Private Practice, São Lucas Medical Institute Criciúma, Santa Catarina, Brazil

    Renan Rocha

  6. Brazilian Association of Psychiatry (ABP), Rio de Janeiro, Brazil

    Antonio Geraldo da Silva

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Osborne, L.M., Leistikow, N., Rocha, R. (2020). FDA Rules for Pregnancy and Lactation Labeling and Their Clinical Implications. In: Rennó Jr., J., Valadares, G., Cantilino, A., Mendes-Ribeiro, J., Rocha, R., Geraldo da Silva, A. (eds) Women's Mental Health. Springer, Cham. https://doi.org/10.1007/978-3-030-29081-8_26

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  • DOI: https://doi.org/10.1007/978-3-030-29081-8_26

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