Topical antibiotics in pregnancy: A review of safety profiles
Viral M. Patel
Department of Dermatology, Stony Brook University Medical Center, Stony Brook, New York
Search for more papers by this authorCorresponding Author
Robert A. Schwartz
Departments of Dermatology and Pathology, Rutgers New Jersey Medical School, Newark, New Jersey
Correspondence
Robert A. Schwartz, Departments of Dermatology and Pathology, Rutgers New Jersey Medical School, 185 South Orange Avenue, Medical Science Building H-576, Newark, NJ 07103-2757.
Email: [email protected]
Search for more papers by this authorW. Clark Lambert
Departments of Dermatology and Pathology, Rutgers New Jersey Medical School, Newark, New Jersey
Search for more papers by this authorViral M. Patel
Department of Dermatology, Stony Brook University Medical Center, Stony Brook, New York
Search for more papers by this authorCorresponding Author
Robert A. Schwartz
Departments of Dermatology and Pathology, Rutgers New Jersey Medical School, Newark, New Jersey
Correspondence
Robert A. Schwartz, Departments of Dermatology and Pathology, Rutgers New Jersey Medical School, 185 South Orange Avenue, Medical Science Building H-576, Newark, NJ 07103-2757.
Email: [email protected]
Search for more papers by this authorW. Clark Lambert
Departments of Dermatology and Pathology, Rutgers New Jersey Medical School, Newark, New Jersey
Search for more papers by this authorAbstract
Medications should be used with caution in women of childbearing age who are pregnant, or are contemplating pregnancy. Although topical medications are considered safer than oral or parenteral agents, their safety data in pregnancy must be assessed carefully. The available information on medication use in pregnancy is limited, and not always aided by the FDA pregnancy letter category system. Thus, in this article, we aggregate human studies, animal studies, and pharmacokinetics data to provide recommendations on utilizing topical antibiotics in pregnancy.
CONFLICTS OF INTEREST
The authors declare no potential conflict of interest.
REFERENCES
- Abramovits, W. (2018). Dapsone in dermatology. In P. S. Yamauchi (Ed.), Biologic and systemic agents in dermatology (pp. 517–524). Cham, Switzerland: Springer International Publishing.
10.1007/978-3-319-66884-0_44 Google Scholar
- Aczone [package insert]. (2018). Irvine. CA: Allergan.
- Akhavan, A., & Bershad, S. (2003). Topical acne drugs: Review of clinical properties, systemic exposure, and safety. American Journal of Clinical Dermatology, 4, 473–492.
- Altabax [product insert]. (2018). Barnard castle, county Durham. UK: GSK.
- Awan, S. Z., & Lu, J. (2017). Management of severe acne during pregnancy: A case report and review of the literature. International Journal of Women's Dermatology, 3, 145–150.
- Bonamonte, D., Belloni Fortina, A., Neri, L., & Patrizi, A. (2014). Fusidic acid in skin infections and infected atopic eczema. Giornale Italiano di Dermatologia e Venereologia, 149, 453–459.
- Bos, J. D., & Meinardi, M. M. (2000). The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Experimental Dermatology, 9, 165–169.
- Briggs, G. (2017). Drugs in pregnancy and lactation: A reference guide to fetal and neonatal risk ( 11th ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
- Burtin, P., Taddio, A., Ariburnu, O., Einarson, T. R., & Koren, G. (1995). Safety of metronidazole in pregnancy: A meta-analysis. American Journal of Obstetrics and Gynecology, 172, 525–529.
- Caro-Paton, T., Carvajal, A., Martin de Diego, I., Martin-Arias, L. H., Alvarez Requejo, A., & Rodriguez Pinilla, E. (1997). Is metronidazole teratogenic? A meta-analysis. British Journal of Clinical Pharmacology, 44, 179–182.
- Cleocin T [package insert]. (2018). New York: Pfizer.
- Czeizel, A. E., Rockenbauer, M., Olsen, J., & Sorensen, H. T. (2000). A teratological study of aminoglycoside antibiotic treatment during pregnancy. Scandanavian Journal of Infectious Disease, 32, 309–313.
- Czeizel, A. E., Rockenbauer, M., Sorensen, H. T., & Olsen, J. (1999). A population-based case-control teratologic study of oral erythromycin treatment during pregnancy. Reproductive Toxicology, 13, 531–536.
- Diav-Citrin, O., Shechtman, S., Gotteiner, T., Arnon, J., & Ornoy, A. (2001). Pregnancy outcome after gestational exposure to metronidazole: A prospective controlled cohort study. Teratology, 63, 186–192.
- Elewski, B. E., Fleischer, A. B., Jr., & Pariser, D. M. (2003). A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: Results of a randomized trial. Archives of Dermatology, 139, 1444–1450.
- Erygel [package insert]. (2018). San Antonio, TX: DPT Laboratories.
- Finacea [package insert]. (2015). Whippany, NJ: Bayer Health.
- Finch, R. G., Greenwood, D., Whitley, R. J., & Norrby, S. R. (2010). Antibiotic and chemotherapy. Edinburgh, UK: Elsevier Health Sciences.
- Fluhr, J., & Degitz, K. (2010). Antibiotics, azelaic acid and benzoyl peroxide in topical acne therapy. Journal of the German Society of Dermatology, 8, S24–S30.
- Fucidin [package insert]. (2017). Berkshire, UK: Leo Laboratories.
- Gelmetti, C. (2008). Local antibiotics in dermatology. Dermatologic Therapy, 21, 187–195.
- Gentamicin [package insert]. (2013). Lake Zurich, IL: Fresenius Kabi USA.
- Gilbert, T., Lelievre-Pegorier, M., Malienou, R., Meulemans, A., & Merlet-Benichou, C. (1987). Effects of prenatal and postnatal exposure to gentamicin on renal differentiation in the rat. Toxicology, 43, 301–313.
- Hale, E. K., & Pomeranz, M. K. (2002). Dermatologic agents during pregnancy and lactation: An update and clinical review. International Journal of Dermatology, 41, 197–203.
- Heinonen, O., Slone, D., & Shapiro, S. (1977). Birth defects and drugs in pregnancy: Maternal drug exposure and congenital malformations. Littleton, MA: Publishing Sciences Group.
- Hocking, D. R. (1968). Neonatal haemolytic disease due to dapsone. The Medical Journal of Australia, 1, 1130–1131.
- Katsambas, A. D., Stefanaki, C., & Cunliffe, W. J. (2004). Guidelines for treating acne. Clinics in Dermatology, 22, 439–444.
- Kazy, Z., Puho, E., & Czeizel, A. E. (2005). Parenteral polymyxin B treatment during pregnancy. Reproductive Toxicology, 20, 181–182.
- Keuter, M., van Eijk, A., Hoogstrate, M., Raasveld, M., van de Ree, M., Ngwawe, W. A., … Brandling-Bennett, A. D. (1990). Comparison of chloroquine, pyrimethamine and sulfadoxine, and chlorproguanil and dapsone as treatment for falciparum malaria in pregnant and non-pregnant women, Kakamega District, Kenya. BMJ, 301, 466–470.
- Kirkwood, A., Harris, C., Timar, N., & Koren, G. (2007). Is gentamicin ototoxic to the fetus? Journal of Obstetrics and Gynaecology Canada, 29, 140–145.
- Koren, G., Pastuszak, A., & Ito, S. (1998). Drugs in pregnancy. New England Journal of Medicine, 338, 1128–1137.
- Leachman, S. A., & Reed, B. R. (2006). The use of dermatologic drugs in pregnancy and lactation. Dermatology Clinics, 24, 167–197.
- Mallie, J. P., Coulon, G., Billerey, C., Faucourt, A., & Morin, J. P. (1988). In utero aminoglycosides-induced nephrotoxicity in rat neonates. Kidney International, 33, 36–44.
- Mattison, D. (2012). Clinical pharmacology during pregnancy ( 1st ed.). Waltham, MA: Academic Press.
- Maurus, J. N. (1978). Hansen's disease in pregnancy. Obstetrics and Gynecology, 52, 22–25.
- McGee, J. S., & Wilkin, J. K. (2018). Prescription to over-the-counter switch of metronidazole and Azelaic acid for treatment of rosacea. JAMA Dermatology, 154, 997–998. https://doi.org/10.1001/jamadermatol.2018.1667
- McGready, R., Cho, T., Samuel, Villegas, L., Brockman, A., van Vugt, M., … Nosten, F. (2001). Randomized comparison of quinine-clindamycin versus artesunate in the treatment of falciparum malaria in pregnancy. Transactions of the Royal Society of Tropical Medicine and Hygiene, 95, 651–656.
- Metrogel [package insert]. (2018). Forth Worth, TX: Gladerma Laboratories.
- Mupirocin [package insert]. (2019). Mahwah, NJ: Glenmark Pharmaceuticals.
- Murase, J. E., Heller, M. M., & Butler, D. C. (2014). Safety of dermatologic medications in pregnancy and lactation: Part I. pregnancy. Journal of the Academy of Dermatology, 70, 401–414 quiz 415.
- Rosa, F., Baum, C., & Shaw, M. (1987). Pregnancy outcomes after first-trimester vaginitis drug therapy. Obstetrics and Gynecology, 69, 751–755.
- Schaefer, C., Peters, P., & Miller, R. (2014). Drugs during pregnancy and lactation ( 3rd ed.). Waltham, MA: Academic Press.
- Schwartz, R. A., & Al-Mutairi, N. (2010). Topical antibiotics in dermatology: An update. The Gulf Journal of Dermatology and Venereology, 17, 1–19.
- Sodium sulfacetamide [package insert]. (2017). San Antonio, TX: BioComp Pharma.
- Sorensen, H. T., Larsen, H., Jensen, E. S., Thulstrup, A. M., Schonheyder, H. C., Nielsen, G. L., & Czeizel, A. (1999). Safety of metronidazole during pregnancy: A cohort study of risk of congenital abnormalities, preterm delivery and low birth weight in 124 women. Journal of Antimicrobial Chemotherapy, 44, 854–856.
- Sulfamylon [package insert]. (2013). Rockford, IL: Mylan Institutional.
- Thapa, P. B., Whitlock, J. A., Brockman Worrell, K. G., Gideon, P., Mitchel, E. F., Jr., Roberson, P., … Ray, W. A. (1998). Prenatal exposure to metronidazole and risk of childhood cancer: A retrospective cohort study of children younger than 5 years. Cancer, 83, 1461–1468.
10.1002/(SICI)1097-0142(19981001)83:7<1461::AID-CNCR25>3.0.CO;2-1 CAS PubMed Web of Science® Google Scholar
- Thiboutot, D., Thieroff-Ekerdt, R., & Graupe, K. (2003). Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: Results from two vehicle-controlled, randomized phase III studies. Journal of the Academy of Dermatology, 48, 836–845.
- Thornton, Y. S., & Bowe, E. T. (1989). Neonatal hyperbilirubinemia after treatment of maternal leprosy. Southern Medical Journal, 82, 668.
- Tyler, K. H. (2015). Dermatologic therapy in pregnancy. Clinical Obstetrics and Gynecology, 58, 112–118.
- van Hoogdalem, E. J. (1998). Transdermal absorption of topical anti-acne agents in man; review of clinical pharmacokinetic data. Journal of the European Academy of Dermatology and Venereology, 11, S13–S19.
- Vickers, C. F. (1969). Percutaneous absorption of sodium fusidate and fusidic acid. British Journal of Dermatology, 81, 902–908.
- Wing, D. A., Hendershott, C. M., Debuque, L., & Millar, L. K. (1998). A randomized trial of three antibiotic regimens for the treatment of pyelonephritis in pregnancy. Obstetrics and Gynecology, 92, 249–253.
- Wolf, K., & Silapunt, S. (2015). The use of sodium sulfacetamide in dermatology. Cutis, 96, 128–130.
- Yeung, D., Nacht, S., Bucks, D., & Maibach, H. I. (1983). Benzoyl peroxide: Percutaneous penetration and metabolic disposition. II. Effect of concentration. Journal of the Academy of Dermatology, 9, 920–924.