Women’s Experiences With Isotretinoin Risk Reduction Counseling

Abstract

Since few clinicians provide women information on highly effective (ie, intrauterine or subdermal) contraceptives, the iPLEDGE program increases anxiety about isotretinoin more than it helps women feel protected from the teratogenic risks of isotretinoin.

The Possibly Reversible Isotretinoin Effect of Decreased Ovarian Reserve in Sprague-Dawley Albinos: Part I, Biochemical Analyses

“…For a long time, the major concern with the isotretinoin administration was its teratogenic potential. Several risk management programs such as the Pregnancy Prevention Program, the System to Manage Accutane-Related Teratogenicity and iPLEDGE, which is a Food and Drug Administration-approved restricted distribution program, were designed to prevent pregnancies by contraceptive recommendations in women who are taking isotretinoin to minimize fetal exposure due to its category-X feature [11,12] . However, the potential toxic effects of isotretinoin on ovaries have gained attention in the last decade.…”

A comparative review of the isotretinoin pregnancy risk management programs across four continents

“…Notably, the new requirement of regular pregnancy tests was not shown to minimize pregnancy rates of users . In fact, it was shown that the iPLEDGE increased user anxiety associated with isotretinoin use more than it protected consumers from its teratogenic risks . Pinheiro et al .…”

Promoting Safe Use of Isotretinoin by Increasing Contraceptive Knowledge

“…Because women treated with isotretinoin as part of the iPLEDGE program often report needing more information regarding available contraceptives, 7 we recommend that dermatologists make this contraceptive information sheet available to all women whom they are considering treating with isotretinoin. Alternatively, updating the materials distributed by the iPLEDGE program to include this contraceptive information would be useful.…”

“…Participants were then provided with a contraceptive information sheet that we developed using materials developed by the World Health Organization, 9 as well as interviews that we had conducted with women who had previously participated in the iPledge program. 7 This information sheet (Figure) outlines each contraceptive's duration of efficacy, risks, and benefits, while highlighting the relative effectiveness of these methods with typical use. The research assistant (C.A.W.)…”

“…6 When interviewed, women who have been treated with isotretinoin report clearly understanding isotretinoin's teratogenic risks, but many indicate that they lacked information on how to effectively avoid unintended pregnancy. 7 In particular, many women reported limited knowledge of the most effective contraceptives, such as the subdermal contraceptive implant and intrauterine contraceptives, 7 and many reported little awareness of the fact that the effectiveness of available contraceptives can differ by an order of magnitude. 8 Nonetheless, women indicated that a contraceptive's effectiveness would be a key factor in their choice of a contraceptive method to use while being treated with isotretinoin.…”