Challenges to Contraceptive Counseling With Isotretinoin Treatment and Future Directions for Dermatologists

Abstract

Accutane, also known as isotretinoin, is an oral systemic retinoid utilized in the treatment of severe, treatment-resistant acne.   Isotretinoin is a pregnancy category X drug, meaning that studies have documented congenital defects in pregnant patients on isotretinoin. Known abnormalities include ear abnormalities, facial dysmorphia, cleft palate, CNS abnormalities, thymus gland abnormalities, and parathyroid hormone deficiencies. With teratogenicity well-documented with isotretinoin use, the iPLEDGE system was created to educate prescribers, pharmacists, and patients about the risks of isotretinoin use. Utilizing iPLEDGE, individuals of child bearing potential (ICBP) are required to document two negative pregnancy tests before the initiation of isotretinoin therapy with two documented forms of birth control. We conducted a literature review utilizing the terms: accutane, isotretinoin, contraception, and birth control. We found that amongst multiple articles,  the most popular primary contraceptive methods in iPLEDGE were abstinence (47% of users) and combined oral contraceptives (31% of users). Individuals have attributed their lack of contraceptive use to fear of birth control health impacts and belief in the equivalent effectiveness of non-accepted methods (e.g. withdrawal and natural family planning. Despite the establishment of iPLEDGE to systematically reinforce counseling requirements, the incidence of isotretinoin-exposed pregnancies continues to persist with approximately 100-200 pregnancies annually. Given these findings, it is clear that counseling is tantamount to dispelling misconceptions regarding contraception and optimizing rates of patient compliance. Despite this importance, counseling remains a large issue for dermatologists. Only half of board-certified dermatology residents surveyed in 2023 felt comfortable providing counseling on adverse effects of combined oral contraceptives (COCs), and only 38.8% felt comfortable providing counseling directions for COCs. Solutions for this include quickly accessing a referral to primary care or OB/GYN and potentially new avenues that are more easily accessible such as the progestin-only oral contraceptive pill that was recently approved for over the counter use by the United States Food and Drug Administration.