Pregnancy, Lactation and Drugs in Dermatology: Topical Therapy
Abstract
The increasing number of drugs used in dermatological a venereological practice demands from the dermatologist an updated knowledge on their safety. In the case of pregnant women or those breastfeeding, the decision on whether or not to prescribe a particular drug must be based on a thoughtful evaluation of the benefits for maternal health and the potential risks to fetus' or infant's well-being. Whenever these patients require topical or systemic therapies, most can be adequately treated with safe and effective options. This part of this article discusses the most recent data on the safety of some of the most commonly used topical drugs in the dermatological context, in women of childbearing age.
Downloads
References
Corton MM, Leveno K, Bloom S, Hauth J, Rouse D, Spong
C. Williams Obstetrics: 23rd ed. New York: McGraw Hill
Professional; 2009.
The Food and Drug Administration. Content and Format
of Labeling for Human Prescription Drug and Biological
Products; Requirements for Pregnancy and Lactation Labeling
[Internet]. 2008 [cited 2016 Nov 7] Available from:
https://federalregister.gov/a/E8-11806.
Carmichael SL, Shaw GM, Ma C, Werler MM, Rasmussen
SA, Lammer EJ, et al. Maternal corticosteroid use and
orofacial clefts. Am J Obstet Gynecol. 2007;197:585.
e1-7; discussion 683-4, e1-7.
Chi C-C, Wang S-H, Wojnarowska F, Kirtschig G, Davies
E, Bennett C. Safety of topical corticosteroids in pregnancy.
Cochrane Database Syst Rev. 2015; CD007346.
Chi C-C, Kirtschig G, Aberer W, Gabbud J-P, Lipozenčić
J, Kárpáti S, et al. Evidence-based (S3) guideline on topical
corticosteroids in pregnancy. Br J Dermatol. 2011;
:943-52.
Hviid A, Mølgaard-Nielsen D. Corticosteroid use
during pregnancy and risk of orofacial clefts.
CMAJ.2011;183:796-804.
Brás S, Mendes-Bastos P, Oliveira A, Amaro C. Alterações
fisiológicas e dermatoses específicas da gravidez. Rev Soc
Port Dermatol Venereol. 2016; 73: 413-23.
Skuladottir H, Wilcox AJ, Ma C, Lammer EJ, Rasmussen
SA, Werler MM, et al. Corticosteroid use and risk of orofacial
clefts. Birt Defects Res A Clin Mol Teratol. 2014;
:499-506.
Chi C-C, Wang S-H, Mayon-White R, Wojnarowska F.
Pregnancy outcomes after maternal exposure to topical
corticosteroids: a UK population-based cohort study.
JAMA Dermatol. 2013; 149:1274-80.
Kulski JK, Hartmann PE. Changes in the concentration of
cortisol in milk during different stages of human lactation.
Aust J Exp Biol Med Sci. 1981; 59:769-78.
Hale TW, Hartmann PE. Hale & Hartmann’s Textbook of
Human Lactation. London: Hale Publishing; 2007.
Butler DC, Heller MM, Murase JE. Safety of dermatologic
medications in pregnancy and lactation: Part II. Lactation.
J Am Acad Dermatol. 2014;70:417.e1-10; quiz 427.
Schaefer C, Peters PWJ, Miller RK. Drugs During Pregnancy
and Lactation: Treatment Options and Risk Assessment.
Oxoford: Academic Press; 2014.
Gouraud A, Bernard N, Millaret A, Bruel M, Paret N, Descotes
J, et al. Follow-up of tacrolimus breastfed babies.
Transplantation. 2012;94:e38-40.
Camera G, Pregliasco P. Ear malformation in baby born
to mother using tretinoin cream. Lancet.1992; 339:687.
Lipson AH, Collins F, Webster WS. Multiple congenital
defects associated with maternal use of topical tretinoin.
Lancet. 1993; 341:1352-3.
Willhite CC, Sharma RP, Allen PV, Berry DL. Percutaneous
retinoid absorption and embryotoxicity. J Invest Dermatol.
; 95:523-9.
Jick SS, Terris BZ, Jick H. First trimester topical tretinoin
and congenital disorders. Lancet.1993; 341:1181-2.
Leachman SA, Reed BR. The use of dermatologic drugs in
pregnancy and lactation. Dermatol Clin. 2006; 24:167-
, vi.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy
and Lactation: A Reference Guide to Fetal and Neonatal
Risk. Philadelphia: Lippincott Williams & Wilkins; 2011.
Tang-Liu DD, Matsumoto RM, Usansky JI. Clinical pharmacokinetics
and drug metabolism of tazarotene: a
novel topical treatment for acne and psoriasis. Clin
Pharmacokinet. 1999; 37:273-87.
Menter A. Pharmacokinetics and safety of tazarotene. J
Am Acad Dermatol.2000; 43:S31–5.
Uchiyama H, Suzuki T, Koike Y, Ono M, Shirakawa K,
Nagata M, et al. Reproductive and developmental toxicity
studies of calcipotriol (MC903):(4) - A perinatal and
postnatal study in rats by subcutaneous administration. J
Toxicol Sci. 1996; 21 Suppl 2:439-55.
Bangsgaard N, Rørbye C, Skov L. Treating psoriasis during
pregnancy: safety and efficacy of treatments. Am J
Clin Dermatol. 2015; 16:389-98.
Rothberg AD, Pettifor JM, Cohen DF, Sonnendecker EW,
Ross FP. Maternal-infant vitamin D relationships during
breast-feeding. J Pediatr. 1982; 101:500-3.
Springer DL, Poston KA, Mahlum DD, Sikov MR. Teratogenicity
following inhalation exposure of rats to a high-
-boiling coal liquid. J Appl Toxicol.1982; 2:260-4.
Franssen ME, van der Wilt GJ, de Jong PC, Bos RP, Arnold
WP. A retrospective study of the teratogenicity of dermatological
coal tar products. Acta Derm Venereol. 1999;
:390-1.
Scheepers PT, van Houtum JL, Anzion RB, Harder R, Bos
RP, van der Valk PG. Uptake of pyrene in a breast-fed
child of a mother treated with coal tar. Pediatr Dermatol.
; 26:184-7.
American Academy of Pediatrics Committee on Drugs.
Transfer of drugs and other chemicals into human milk.
Pediatrics. 2001; 108:776-89.
Al-jedai Ahmed H., Balhareth SS, Algain RA. Assessment
of foetal risk associated with 93 non-US-FDA approved
medications during pregnancy. Saudi Pharm J. 2012;
:287-99.
McKelvy JF, LeBlanc P, Laudes C, Perrie S, Grimm-Jorgensen
Y, Kordon C. The use of bacitracin as an inhibitor of
the degradation of thyrotropin releasing factor and luteinizing
hormone releasing factor. Biochem Biophys Res
Commun. 1976; 73:507-15.
Patthy A, Gráf L, Kenessey A, Székely JI, Bajusz S. Effect
of bacitracin on the biodegradation of beta-endorphin.
Biochem Biophys Res Commun. 1977; 79:254-9.
Hale EK, Pomeranz MK. Dermatologic agents during
pregnancy and lactation: an update and clinical review.
Int J Dermatol. 2002; 41:197-203.
GlaxoSmithKline. Prescribing information BACTROBAN®
Cream [Internet]. [cited 2016 Jul 14];Available from:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/
US/en/Prescribing_Information/Bactroban_
Cream/pdf/BACTROBAN-CREAM.PDF
Murase JE, Heller MM, Butler DC. Safety of dermatologic
medications in pregnancy and lactation: Part I. Pregnancy.
J Am Acad Dermatol. 2014; 70:401.e1-14; quiz 415.
Pulkkinen MO, Willman K. Reduction of maternal estrogen
excretion by neomycin. Am J Obstet Gynecol. 1973;
:1153.
Mavrogenis S, Urban R, Czeizel AE, Acs N. Maternal
risk factors in the origin of isolated hypospadias: a
population-based case-control study. Congenit Anom.
; 54:110-5.
Mactal-Haaf C, Hoffman M, Kuchta A. Use of anti-infective
agents during lactation, Part 3: Antivirals, antifungals,
and urinary antiseptics. J Hum Lact. 2001; 17:160-6.
Brent NB. Thrush in the breastfeeding dyad: results of a
survey on diagnosis and treatment. Clin Pediatr. 2001;
:503-6.
Pilmis B, Jullien V, Sobel J, Lecuit M, Lortholary O, Charlier
C. Antifungal drugs during pregnancy: an updated
review. J Antimicrob Chemother. 2015; 70:14-22.
Johnstone HA, Marcinak JF. Candidiasis in the breastfeeding
mother and infant. J Obstet Gynecol Neonatal Nurs.
; 19:171-3.
Moudgal VV, Sobel JD. Antifungal drugs in pregnancy: a
review. Expert Opin Drug Saf. 2003; 2:475-83.
Roos TC, Alam M, Roos S, Merk HF, Bickers DR. Pharmacotherapy
of ectoparasitic infections. Drugs. 2001;
:1067-88.
Scott GR, Chosidow O, IUSTI/WHO. European guideline
for the management of scabies, 2010. Int J STD AIDS.
; 22:301-3.
Angel TA, Nigro J, Levy ML. Infestations in the pediatric
patient. Pediatr Clin North Am. 2000; 47:921-35, viii.
Rojansky N, Fasouliotis SJ, Ariel I, Nadjari M. Extreme
caudal agenesis. Possible drug-related etiology? J Reprod
Med. 2002; 47:241-5.
Smorlesi C, Caldarella A, Caramelli L, Di Lollo S, Moroni
F. Topically applied minoxidil may cause fetal malformation:
a case report. Birt Defects Res A Clin Mol Teratol.
; 67:997-1001.
Shapiro J. Safety of topical minoxidil solution: a one-
-year, prospective, observational study. J Cutan Med Surg.
; 7:322-9.
Mahé A, Perret JL, Ly F, Fall F, Rault JP, Dumont A. The cosmetic
use of skin-lightening products during pregnancy
in Dakar, Senegal: a common and potentially hazardous
practice. Trans R Soc Trop Med Hyg. 2007; 101:183-7.
Krasavage WJ, Blacker AM, English JC, Murphy SJ. Hydroquinone:
a developmental toxicity study in rats. Fundam
Appl Toxicol. 1992; 18:370-5.
Wester RC, Melendres J, Hui X, Cox R, Serranzana S, Zhai
H, et al. Human in vivo and in vitro hydroquinone topical
bioavailability, metabolism, and disposition. J Toxicol Environ
Health A. 1998; 54:301-17.
Goldberg D, Maloney M. Dermatologic surgery and cosmetic
procedures during pregnancy and the post-partum
period. Dermatol Ther. 2013; 26:321-30.
Bachrach LK, Burrow GN, Gare DJ. Maternal-fetal absorption
of povidone-iodine. J Pediatr. 1984; 104:158-9.
Casteels K, Pünt S, Brämswig J. Transient neonatal hypothyroidism
during breastfeeding after post-natal maternal
topical iodine treatment. Eur J Pediatr. 2000;
:716-7.
Moore PA. Selecting drugs for the pregnant dental patient.
J Am Dent Assoc. 1998; 129:1281-6.
Santos AC, Pedersen H, Harmon TW, Morishima HO,
Finster M, Arthur GR, et al. Does pregnancy alter the systemic
toxicity of local anesthetics? Anesthesiology. 1989;
:991-5.
Suresh L, Radfar L. Pregnancy and lactation. Oral Surg
Oral Med Oral Pathol Oral Radiol Endod. 2004; 97:672-
Sweeney SM, Maloney ME. Pregnancy and dermatologic
surgery. Dermatol Clin. 2006; 24:205-14, vi.
Rieken SE, Terezhalmy GT. The pregnant and breast-feeding
patient. Quintessence Int. 1985 2006; 37:455-68.
De Oliveira Monteiro E. Botulinum toxin and pregnancy.
Skinmed. 2006; 5:308.
Tan M, Kim E, Koren G, Bozzo P. Botulinum toxin type A in
pregnancy. Can Fam Physician. 2013; 59:1183-4.
Aranda MA, Herranz A, del Val J, Bellido S, García-Ruiz P.
Botulinum toxin A during pregnancy, still a debate. Eur J
Neurol. 2012; 19:e81-2.
Li Yim JFT, Weir CR. Botulinum toxin and pregnancy-a
cautionary tale. Strabismus. 2010; 18:65-6.
Paul M. Controversy: botulinum toxin in pregnancy. J
Cutan Aesthetic Surg. 2009; 2:4-5.
Polo JM, Martin J, Berciano J. Botulism and pregnancy.
Lancet. 1996; 348:195.
Robin L, Herman D, Redett R. Botulism in a pregnant
women. N Engl J Med. 1996; 335:823-4.
St Clair EH, DiLiberti JH, O’Brien ML. Letter: Observations
of an infant born to a mother with botulism. J Pediatr.
; 87:658.
Morrison GA, Lang C, Huda S. Botulism in a pregnant
intravenous drug abuser. Anaesthesia. 2006; 61:57-60.
Magri K, Bresson V, Barbier C. Botulism and pregnancy.
Biol Reprod 2006; 35:624-6.
Middaugh J. Botulism and breast milk. N Engl J Med.
; 298:343.
Babalola O, Strober BE. Management of psoriasis in
pregnancy. Dermatol Ther. 2013; 26:285-92.
El-Saie LT, Rabie AR, Kamel MI, Seddeik AK, Elsaie ML.
Effect of narrowband ultraviolet B phototherapy on serum
folic acid levels in patients with psoriasis. Lasers Med Sci.
; 26:481-5.
Park KK, Murase JE. Narrowband UV-B phototherapy during
pregnancy and folic acid depletion. Arch Dermatol.
; 148:132-3.
Juzeniene A, Stokke KT, Thune P, Moan J. Pilot study of
folate status in healthy volunteers and in patients with
psoriasis before and after UV exposure. J Photochem
Photobiol B. 2010; 101:111-6.
Gunnarskog JG, Källén AJ, Lindelöf BG, Sigurgeirsson
B. Psoralen photochemotherapy (PUVA) and pregnancy.
Arch Dermatol. 1993; 129:320-3.
Stern RS, Lange R. Outcomes of pregnancies among
women and partners of men with a history of exposure
to methoxsalen photochemotherapy (PUVA) for the treatment
of psoriasis. Arch Dermatol. 1991; 127:347-50.
Madan RK, Levitt J. A review of toxicity from topical salicylic
acid preparations. J Am Acad Dermatol. 2014;
:788-92.
Larsson KS, Bostroem H. Teratogenic actions of salicylates
related to the inhibition of mucopolysaccharide synthesis.
Acta Paediatr Scand. 1965; 54:43-8.
Täuber U, Weiss C, Matthes H. Percutaneous absorption
of azelaic acid in humans. Exp Dermatol. 1992; 1:176-9.
Akhavan A, Bershad S. Topical acne drugs: review of clinical
properties, systemic exposure, and safety. Am J Clin
Dermatol. 2003; 4:473-92.
Lopaschuk CC. New approach to managing genital
warts. Can Fam Physician. 2013; 59:731-6.
Ciavattini A, Tsiroglou D, Vichi M, Di Giuseppe J, Cecchi
S, Tranquilli AL. Topical Imiquimod 5% cream therapy
for external anogenital warts in pregnant women: report
of four cases and review of the literature. J Matern-Fetal
Neonatal. 2012; 25:873-6.
Stricker RB, Elswood BF. Dendritic cells and dinitrochlorobenzene (DNCB): a new treatment approach to AIDS. Immunol Lett. 1991; 29:191-6.
All articles in this journal are Open Access under the Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
