Acitretin Prescribing Patterns in Women of Childbearing Potential

July 2013 | Volume 12 | Issue 7 | Original Article | 799 | Copyright © 2013

Scott A. Davis MA,a Brad A. Yentzer MD,a and Steven R. Feldman MD PhDa,b,c

aCenter for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC
bCenter for Dermatology Research, Department of Pathology, Wake Forest University School of Medicine, Winston-Salem, NC
cPublic Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC

Abstract

BACKGROUND: Acitretin is indicated for severe psoriasis, but it is also a potent teratogen whose use should be avoided in women of childbearing potential. Topical medications, phototherapy, cyclosporine A, and new biologic agents provide safer alternatives for women of childbearing age with moderate to severe psoriasis.
PURPOSE: To determine the demographics of acitretin prescribing patterns as an assessment of acitretin use in women of child-bearing potential.
METHODS: We examined National Ambulatory Medical Care Survey (NAMCS) data from the years 1990-2009 to determine demographic data on patients who were prescribed etretinate or acitretin. We used age under 50 as a proxy for childbearing potential.
RESULTS: From 1996-2009, there were an estimated 29 million office visits for psoriasis. Females accounted for 14.3 million of these visits, and 6.5 million (45.6%) of them were under the age of 50. The NAMCS contained only one record of a female patient under the age of 50 being prescribed acitretin from 1996-2009, the years during which acitretin had been available in the United States. This corresponds to an estimated 2.3% of all psoriasis patients prescribed acitretin during this time (20,000 out of 890,000).
LIMITATIONS: The NAMCS estimates national trends based on a large nationwide database. While the use of acitretin in women under 50 is low, the precision of the estimate is limited by the small sample size provided by this database.
CONCLUSIONS: There are now many alternative treatments besides acitretin for women of childbearing potential with moderate to severe psoriasis. Acitretin is used at most infrequently in this population. In females of reproductive potential, acitretin should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.

J Drugs Dermatol. 2013;12(7):799-802.

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INTRODUCTION

Psoriasis is a chronic and potentially debilitating disease that affects 2% to 3% of the population.1, 2 Approximately 50% of these patients are female, many of childbearing potential. A previous study of psoriasis-related office visits by female patients revealed that 44% were by women ages 10 to 49 years of age.3 This raises fetal safety concerns for pregnancies occurring during psoriasis treatment. While mild forms of psoriasis can be treated with topical preparations, more severe forms may require therapy with systemic medications, which may entail substantial teratogenic risk.

Acitretin, approved by the U.S. Food and Drug Administration for psoriasis in 1996, is a potent teratogen. The relative risk of fetal malformation in pregnancies with exposure to oral retinoids is 25.6 times that of the general population, and all systemic retinoids are contraindicated in pregnancy.4 Strict pregnancy prevention in female acitretin users of child-bearing potential is required.5, 6 The manufacturer has received a total of 6 reported cases of fetal malformation in mothers using acitretin during pregnancy.6-8 Because oral retinoids pose a serious risk of teratogenicity both during treatment and potentially for years after completion, oral retinoids should not be used in women of childbearing potential when other options are available.

This study examines the prevalence of oral retinoid use in female psoriasis patients of childbearing age. Alternative treatments should be used when possible in these patients. Safer options for severe psoriasis in women of childbearing potential may include cyclosporine, PUVA, narrow band UVB therapy, and biologic agents.9-14 While we anticipate that few physicians prescribe acitretin to women of childbearing potential, nationally representative data are lacking. We examined the National Ambulatory Medical Care Survey (NAMCS) from the years 1990-2009 to determine the demographics of patients who were prescribed etretinate or acitretin in order to gain a sense of the magnitude of use in these women.

METHODS

The National Ambulatory Medical Care Survey (NAMCS) includes patient data from non-federally-employed, office-based

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