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Review

Systemic medications used in treatment of common dermatological conditions: safety profile with respect to pregnancy, breast feeding and content in seminal fluid

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Pages 2-18 | Received 02 Apr 2015, Accepted 29 Jan 2016, Published online: 13 Sep 2018

References

  • Briggs GG, Freeman RK, Yaffe SJ. Acitretin. Drugs in Pregnancy and Lactation, 9th ed. Philadelphia: Wolters Kluwer, Lippincott Williams and Wilkins; 2011.
  • Lammer EJ, Chen DT, Hoar RM, et al. Retinoic acid embryopathy. N Engl J Med. 1985;313:837–41.
  • Use of Acitretin/Etitretinate in Pregnancy. UK Teratology Information Service, 2012.
  • Barbero P, Lotersztein V, Bronberg R, et al. Acitretin embryopathy: a case report. Birth Defects Res Part A Clin Mol Teratol. 2004;70:831–3.
  • Sturkenboom MC, de Jong-Van Den Berg LT, van Voorst-Vader PC, et al. Inability to detect plasma etretinate and acitretin is a poor predictor of the absence of these teratogens in tissue after stopping acitretin treatment. Br J Clin Pharmacol. 1994;38:229–35.
  • Logistics H. Neotigason Data Sheet. International Core Data Sheet. In: Logistics H, ed. Pharmacy Retailing NZ ltd Healthcare Logistics. New Zealand Medicines and Medical Devices Safety Authority; 2010.
  • Maier H, Honigsmann H. Assessment of acitretin-treated female patients of childbearing age and subsequent risk of teratogenicity. Br J Dermatol. 2001;145:1027–8.
  • Rollman O, Pihl-Lundin I. Acitretin excretion into human breast milk. Acta Derm Venereol. 1990;70:487–90.
  • Geiger JM, Walker M. Is there a reproductive safety risk in male patients treated with acitretin (neotigason/soriatane? Dermatology (Basel). 2002;205:105–7.
  • Millsop JW, Heller MM, EM J, MJ E. Dermatological medication effects on male fertility. Dermatologic Therapy. 2013;26:337–46.
  • Briggs GG, Freeman RK, Yaffe SJ, Tretinoin (Topical). Drugs in Pregnancy and Lactation. 9th ed. Philadelphia: Wolters Kluwer, Lippincott Williams and Wilkins; 2011.
  • Selcen D, Seidman S, Nigro MA. Otocerebral anomalies associated with topical tretinoin use. Brain Dev. 2000;22:218–20.
  • Lipson AH, Collins F, Webster WS. Multiple congenital defects associated with maternal use of topical tretinoin. The Lancet. 1993;341:1352–3.
  • Panchaud A, Csajka C, Merlob P, et al. Pregnancy outcome following exposure to topical retinoids: a multicenter prospective study. J Clin Pharmacol. 2012;52:1844–51.
  • Loureiro KD, Kao KK, Jones KL, et al. Minor malformations characteristic of the retinoic acid embryopathy and other birth outcomes in children of women exposed to topical tretinoin during early pregnancy. Am J Med Genet Part a. 2005;136:117–21.
  • Martinez-Frias ML, Rodriguez-Pinilla ER. First-trimester exposure to topical tretinoin: its safety is not warranted. Teratology. 1999;60:(1):5.
  • GSK. Alitretinoin Information Leaflet. In: GSK, ed. England, Wales: GlaxoSmithKline; 2012.
  • Schmitt-Hoffmann AH, Roos B, Sauer J, et al. Low levels of alitretinoin in seminal fluids after repeated oral doses in healthy men. Clin Exp Dermatol. 2011;36(Supplement 2):12–17.
  • Ayme S, Julian C, Gambarelli D, et al. Isotretinoin dose and teratogenicity. Lancet. 1988;1:655.
  • Jahn AF, Ganti K. Major auricular malformations due to Accutane (isotretinoin). Laryngoscope. 1987;97:832–5.
  • Cohen M, Rubenstein A, Jk L, Natheson G. Thymic hypoplasia associated with isotretinoin embryopathy. Am J Dis Child. 1987;141:263–6.
  • Stern RS, Rosa F, Baum C. Isotretinoin and pregnancy. J Am Acad Dermatol. 1984;10:851–4.
  • Briggs GG, Freeman RK, Yaffe SJ. Isotretinoin. Drugs in Pregnancy and Lactation. 9th ed. Philadelphia: Wolters Kluwer, Lippincott Williams and Wilkins; 2011. p. 777–8.
  • Use of Isotretinoin in Pregnancy [Internet]. UK Teratology Information Service. 2008.
  • Pharma R. Roaccutane patient product information leaflet. United Kingdom: Roche Pharma AG; 2012.
  • Hoting VE, Schutte B, Schirren C. Isotretinoin treatment of acne conglobata. Andrological follow up. Fortschr Med. 1992;110(23):427–30.
  • Padmanabhan S, Tripathi DN, Vikram A, et al. Methotrexate-induced cytotoxicity and genotoxicity in germ cells of mice: Intervention of folic and folinic acid. Mutation Res. 2009;673:43–52.
  • MacDonald K, Norman WV, Popescu O. New anomalies due to methotrexate and misoprostol exposure in early pregnancy. Int J Gynaecol Obstetr. 2013;122:267–8.
  • Briggs GG, Freeman RK, Yaffe SJ. Methotrexate. Drugs in Pregnancy and Lactation. 9th ed. Philadelphia: Wolters Kluwer, Lippincott Williams and Wilkins; 2011. p. 928–32.
  • Bawle EV, Conard JV, Weiss L. Adult and two children with fetal methotrexate syndrome. Teratology. 1998;57:51–5.
  • Lloyd ME, Carr M, McElhatton P, et al. The effects of methotrexate on pregnancy, fertility and lactation. QJM. 1999;92:551–63.
  • Roman Corona-Riviera J, Rea-Rosas A, Santana-Ramirez A, et al. Holoprosencephaly and genitourinary anomalies in fetal methotrexate syndrome. Am J Med Genet. 2010;152A:1741–6.
  • Use of Low Dose Methotrexate in Pregnancy. UK Teratology Information Service. 2010.
  • Pediatrics CoD-AAo. The transfer of drugs and other chemicals into human milk. Pediatrics. 2001;108:776–89.
  • Paternal Exposure to Methotrexate [Internet]. UK Teratology Information Service. 2010.
  • Grunewald S, Paasch U, Glander H-J. Systemic dermatological treatment with relevance for male fertility. J Dtsch Dermatol Ges. 2007;5:15–21.
  • Use of Mycophenylate Mofetil in Pregnancy [Internet]. UK Teratology Information Service. 2010.
  • Briggs GG, Freeman RK, Yaffe SJ. Mycophenolate. Drugs in Pregnancy and Lactation. 9th ed. Philadelphia: Wolters Kluwer, Lippincott Williams and Wilkins; 2011.
  • Vento M, Perez Aytes A, Ledo A, et al. Mycophenolate mofetil during pregnancy: some words of caution. Pediatrics. 2008;122:184–5.
  • Kim M, Rostas S, Gabardi S. Mycophenolate fetal toxicity and risk evaluation and mitigation strategies. Am J Transplant. 2013;13:1383–9.
  • Hoeltzenbein M, Elefant E, Vial T, et al. Teratogenicity of mycophenolate confirmed in a prospective study of the European network of teratology information services. Am J Med Genet. 2012;158A(3):588–96.
  • Anderka MT, Lin A, E, Abuelo DN, et al. Reviewing the evidence for mycophenolate mofetil as a new teratogen: case report and review of the literature. Am J Med Genet A. 2009;149A:(Part A):1241–8.
  • Tjeertes IFA, Bastiaans DET, van Ganzewinkel CJLM, Zegers SHJ. Neonatal anemia and hydrops fetalis after maternal mycophenolate mofetil use. J Perinatol. 2007;27:62–4.
  • Ostensen M, Forger F. How safe are anti-rheumatic drugs during pregnancy? Curr Opin Pharmacol. 2013;13:470–5.
  • Roll A, Reich K, Boer A. Use of fumaric acid esters in psoriasis. Indian J Dermatol Venereol Leprol. 2007;73:1337.
  • Photochemotherapy and fumaric acid. In: Schaefer C, Peters P, Miller RK, ed. Drugs During Pregnancy and Lactation Treatment options and risk assessment. 2nd ed. Great Britain: Elsevier; 2007. p. 456.
  • Fumaric Acid Esters Information Leaflet [Internet]. British Association of Dermatologists. 2010.
  • Connell WR. Safety of drug therapy for inflammatory bowel disease in pregnant and nursing women. Inflamm Bowel Dis. 1996;2:33–47.
  • Venkataramanan R, Koneru B, Wang C-CP, et al. Cyclosporine and its metabolites in mother and baby. Transplantation. 1988;46:468–9.
  • Briggs GG, Freeman RK, Yaffe SJ. Cyclosporine. Drugs in Pregnancy and Lactation. 9th ed. Philadelphia: Wolters Kluwer, Lippincott Williams and Wilkins; 2011. p. 351–3.
  • Bae Y-SC, Van Voorhees AS, Hsu S, et al. Review of treatment options for psoriasis in pregnant or lactating women: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2012;67(3):459–77.
  • Cochat P, Decramer S, Robert-Gnansia E, Dubourg L. Renal outcome of children exposed to cyclosporine in utero. Transplant Proc. 2004;36(Supplement 2S):208S–10S.
  • Use of Ciclosporin in Pregnancy [Internet]. UK Teratology Information Service. 2011.
  • Nulman I, Edell H. Paediatric outcomes following in utero exposure to the diagnosis and treatment of maternal malignancy. Eur J Cancer. 2011;47:S217–S29.
  • Morton A. Cyclosporine and lactation. Nephrology (Carlton). 2011;16:249–50.
  • Thiru Y, Bateman DN, Coulthard MG. Successful breast feeding while mother was taking cyclosporin. BMJ. 1997;315:463.
  • Seethalakshmi L, Flores C, Carboni AA, et al. Cyclosporine: its effects on testicular function and fertility in the prepubertal rat. J Androl. 1990;11:17–24.
  • Use of Azathioprine/6-Mercaptopurine in Pregnancy [Internet]. UK Teratology Information Service. 2010.
  • Hutson JR, Lubetsky A, Walfisch A, et al. The transfer of 6-mercaptopurine in the dually perfused human placenta. Reprod Toxicol. 2011;32:349–53.
  • Sauk J, Kane S. The use of medications for inflammatory bowel disease during pregnancy and nursing. Expert Opin Pharmacother. 2005;6:1833–9.
  • Matalon ST, Ornoy A, Lishner M. Review of the potential effects of three commonly used antineoplastic and immunosuppressive drugs (cyclophosphamide, azathioprine, doxorubicin on the embryo and placenta). Reprod Toxicol. 2004;18:219–30.
  • Briggs GG, Freeman RK, Yaffe SJ. Azathioprine. Drugs in Pregnancy and Lactation. 9th ed. Philadelphia: Wolters Kluwer, Lippincott Williams and Wilkins; 2011. p. 120–1.
  • Shim L, Eslick GD, Simring AA, et al. The effects of azathioprine on birth outcomes in women with inflammatory bowel disease (IBD). J Crohns Colitis. 2011;5:234–8.
  • Cleary BJ, Kallen B. Early pregnancy azathioprine use and pregnancy outcomes. Birth Defects Res Part A Clin Mol Teratol. 2009;85:647–54.
  • Temprano KK, Bandlamudio MD, Moore TL. Antirheumatic drugs in pregnancy and lactation. Semin Arthritis Rheum. 2005;35:112–21.
  • Davison JM, Dellagrammatikas H, Parkin JM. Maternal azathioprine therapy and depressed haemopoiesis in the babies of renal allograft patients. Br J Obstet Gynaecol. 1985;92:233–9.
  • Ng SW, Mahadevan U. Management of inflammatory bowel disease in pregnancy. Expert Rev Clin Immunol. 2013;9:161–74.
  • Meggitt SJ, Anstey AV, Mohd Mustapa MF, et al. British association of Dermatologists' guidelines for the safe and effective prescribing of azathioprine. Br J Dermatol. 2011;165:711–34.
  • Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med. 2000;160:610–19.
  • Christensen LA, Dahlerup JF, Nielsen MJ, et al. Azathioprine treatment during lactation. Aliment Pharmacol Ther. 2008;28:1209–13.
  • Angelberger S, Reinisch W, Messerschmidt A, et al. Long-term follow-up of babies exposed to azathioprine in utero and via breastfeeding. J Crohns Colitis. 2011;5:95–100.
  • Sau A, Clarke S, Kaiser A, et al. Azathioprine and breastfeeding: is it safe? BJOG. 2007;114:498–501.
  • Gardiner SJ, Gearry RB, Roberts RL, et al. Exposure to thiopurine drugs through breast milk is low based on metabolite concentrations in mother-infant pairs. Br J Clin Pharmacol. 2006;62:453–6.
  • Paternal Use of Azathioprine/6-Mercaptopurine [Internet]. UK Teratology Information Service. 2010.
  • Braunstein I, Werth V. Treatment of dermatologic connective tissue disease and autoimmune blistering disorders in pregnancy. Dermatologic Therapy. 2013;26:354–63.
  • Diav-Citrin O, Blyakhman S, Shechtman S, Ornoy A. Pregnancy outcome following in utero exposure to hydroxychloroquine: A prospective comparative observational study. Reprod Toxicol. 2013;39:58–62.
  • Costedoat-Chalumeau N, Amoura Z, Duhaut P, et al. Safety of hydroxychloroquine in pregnant patients with connective tissue diseases: a study of one hundred thirty-three cases compared with a control group. Arthritis Rheum. 2003;48:3207–11.
  • Clowse MEB, Magder L, Witter F, Petri M. Hydroxychloroquine in lupus pregnancy. Arthritis Rheum. 2006;54:3640–7.
  • Izmirly PM, Kim MY, Llanos C, et al. Evaluation of the risk of anti-SSA/Ro-SSB/La antibody-associated cardiac manifestations of neonatal lupus in fetuses of mothers with systemic lupus erythematosus exposed to hydroxychloroquine. Ann Rheum Dis. 2010;69:1827–30.
  • Renault F, Flores-Guevara R, Renaud C, et al. Visual neurophysiological dysfunction in infants exposed to hydroxychloroquine in utero. Acta Paediatr. 2009;98(9):1500–3.
  • Climaz R, Brucato A, Meregalli E, et al. LETTERS: electroretinograms of children born to mothers treated with hydroxychloroquine during pregnancy and breast-feeding: comment on the article by Costedoat-Chalumeau et al. Arthritis Rheum. 2004;50:3049–60.
  • Sperber K, Horn C, Chao CP, et al. Systematic review of hydroxychloroquine use in pregnant patients with autoimmune diseases. Pediatr Rheumatol Online J. 2009;7:9.
  • Ostensen M, Motta M. Therapy Insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007;3:400–6.
  • Nicola WG, Khayria MI, Osfor MM. Plasma testosterone level and the male genital system after chloroquine therapy. Boll Chim Farm. 1997;136:39–43.
  • Use of Chloroquine in Pregnancy [Internet]. UK Teratology Information Service. 2008.
  • Brabin BJ, Egglete TA, Parise M, Verhoeff F. Dapsone therapy for malaria during pregnancy: maternal and fetal outcomes. Drug Safety. 2004;27:633–48.
  • Briggs GG, Freeman RK, Yaffe SJ. Dapsone. Drugs in Pregnancy and Lactation. 9th ed. Philadelphia: Wolters Kluwer, Lippincott Williams and Wilkins; 2011. p. 366–8.
  • Tuffanelli DL. Successful pregnancy in a patient with dermatitis herpetiformis treated with low-dose dapsone. Arch Dermatol. 1982;118:876.
  • Use of Etanercept in Pregnancy [Internet]. UK Teratology Information Service. 2011.
  • Briggs GG, Freeman RK, Yaffe SJ. Etancercept. In: Wilkins LWa, ed. Drugs in Pregnancy and Lactation. 9th ed. Philadelphia: Wolters Kluwer, Lippincott Williams and Wilkins; 2011. p. 351–3.
  • Berthlot J-M, Bandt MD, Goupille P, et al. Exposition to anti-TNF drugs during pregnancy: outcome of 15 cases and review of the literature. Joint Bone Spine. 2009;76:28–34.
  • Carter JD, Ladhani A, Ricca LR, et al. A safety assessment of tumour necrosis factor antagonists during pregnancy: a review of the food and drug administration database. J Rheumatol. 2008;36:635–41.
  • Murase JE, Heller M, Butler DC. Safety of dermatologic medications in pregnancy and lactation, Part 1 Pregnancy. J Am Acad Dermatol. 2014;70:401 e1–14.
  • Keeling S, Wolbink G-J. Measuring Multiple Etanercept Levels in the Breast Milk of a Nursing Mother with Rheumatoid Arthritis.
  • Berthelsen BG, Fjeldsoe-Nielsen H, Nielsen CT, et al. Etanercept concentration in maternal serum, umbilical cord serum, breast milk and child serum during breastfeeding. Rheumatology. 2010;49:2225–7.
  • Borrego L. Etanercep in pregnancy and breast-feeding. Actas Dermosfiliogr. 2010;101(Supplement 1):97–101.
  • Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation. J Am Acad Dermatol. 2014;70:e1–417. e10.
  • Use of Infliximab in Pregnancy [Internet]. UK Teratology Information Service. 2009.
  • Briggs GG, Freeman RK, Yaffe SJ. Infliximab. Drugs in Pregnancy and Lactation. 9th ed. Lippincott Williams and Wilkins, 2011. p. 744–7.
  • Marchioni RM, Lichenstein GR. Tumour necrosis factor-alpha inhibitor therapy and fetal risk: a systematic literature review. World J Gastroenterol. 2013;19:2591–602.
  • Shrim A, Koren G. Tumour necrosis factor alpha and use of infliximab – saftey during pregnancy. Can Fam Physician. 2005;51.
  • Yiu ZZN, Griffiths CEM, Warren RB. Safety of biological therapies for psoriasis: effects on reproductive potential and outcomes in male and female patients. Br J Dermatol. 2014;171(3):485–91.
  • Zelinkova Z, de Haar C, de Riddler L, et al. High intra-uterine exposure to infliximab following maternal anti-TNF treatment during pregnancy. Aliment Pharmacol Ther. 2011;33:1053–8.
  • O'Donnell S, O'Morain C. Review article: use of anti-tumour necrosis factor therapy in inflammatory bowel disease during pregnancy and conception. Aliment Pharmacol Ther. 2008;27:885–94.
  • Cheent K, Nolan J, Sohail S, et al. Case report: fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's disease. J Crohns Colitis. 2010;4:603–5.
  • Ben-Horin S, Yavzori M, Kopylov U, et al. Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis. 2011;5:555–8.
  • Paschou S, Voulgari PV, Vrabie IG, et al. Fertility and reproduction in male patients with ankylosing spondylitis treated with infliximab. J Rheumatol. 2009;36:351–4.
  • Saougou J, Markatseli TE, Papagoras C, et al. Fertility in male patients with seronegative spondyloarthropathies treated with infliximab. Joint Bone Spine. 2013;80:34–7.
  • Briggs GG, Freeman RK, Yaffe SJ. Adalimumab. Drugs in Pregnancy and Lactation. Lippincott Williams nad Wilkins, 2011. p. 23–5.
  • Use of Adalimumab in Pregnancy [Internet]. UK Teratology Information Service. Public Health England; 2011.
  • Jürgens M, Brand S, Filik L, et al. Safety of adalimumab in Crohn's disease during pregnancy: case report and review of the literature. Inflamm Bowel Dis. 2010;16:1634–6.
  • Briggs GG, Freeman RK, Yaffe SJ. Ustekinumab. Drugs in Pregnancy and Lactation. Lippincott Williams and Wilkins, 2011. p. 1502–3.
  • Martin PL, Sachs C, Imai N, et al. Development in the Cynomolgus macaque following administration of ustekinumab, a human anti-IL-12/23p40 monoclonal antibody, during pregnancy and lactation. Birth Defects Research Part B: Developmental and Reproductive Toxicology. Wiley-Liss Inc;. 2010;89:351–63.
  • Fotiadou C, Lazaridou E, Sotiriou E, Ioannides D. Spontaneous abortion during ustekinumab therapy. J Dermatol Case Rep. 2012;4:105–7.

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