Eye of the Beholder: iPLEDGE and Acne Treatments

Patients with severe, scarring acne used to have no choice but to live with the condition and its consequences. Fortunately, we have isotretinoin, a vitamin A derivative that is basically a miracle treatment for severe acne. There are few things as gratifying in dermatology as to be able to make such huge, beneficial impacts on patients’ lives. As one of the most powerful teratogens on Earth, isotretinoin is awesome for patients with severe acne—but when inappropriately used, it can also potentially be horrible.

The iPLEDGE program was designed to help prevent isotretinoin-induced birth defects. This program has probably helped in some way, almost certainly by preventing some people who were already pregnant from starting isotretinoin treatment. However, iPLEDGE has also been a bit of a hassle since it first came out. Worse, the recent changes in the iPLEDGE program this month have not gone smoothly. Some might say that it has been a debacle; some might say it’s been a considerable inconvenience to doctors and our patients. The problem’s severity is largely in the eye of the beholder. 

We have options. Many patients are poorly adherent to isotretinoin and may have enough extra pills saved up to take one every other day until the current iPLEDGE issues are resolved. Some patients may just take a break in treatment until they can get medication again, probably with no major, life-changing adverse consequences.

Importantly, we could also prescribe over-the-counter vitamin A (Table). In doses of 50,000 to 100,000 IU per day, it may also be effective. Vitamin A, like its cousin isotretinoin, is teratogenic.^1,2 When prescribing vitamin A for acne, it is prudent to do the same kind of monitoring (liver function, lipids, and pregnancy tests) as would be done for isotretinoin and to assure that patients don’t become pregnant while on vitamin A treatment. Vitamin A has a much longer half-life than isotretinoin and women should wait at least 3 months following treatment cessation before getting pregnant (Table).

Ms Cook is a research fellow at Wake Forest University School of Medicine, Department of Dermatology in Winston-Salem, NC. Mr Perche is a research fellow at Wake Forest University School of Medicine, Department of Dermatology in Winston-Salem, NC. Dr Feldman is with the Center for Dermatology Research and the departments of dermatology, pathology, and social sciences & health policy at Wake Forest University School of Medicine and the department of dermatology at the University of Southern Denmark in Odense, Denmark.

Disclosures: Ms Cook and Mr Perche have no relevant financial relationships. Dr Feldman has received research, speaking and/or consulting support from a variety of companies including Galderma, GSK/Stiefel, Almirall, Leo Pharma, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Valeant, Abbvie, Samsung, Janssen, Lilly, Menlo, Merck, Novartis, Regeneron, Sanofi, Novan, Qurient, National Biological Corporation, Caremark, Advance Medical, Sun Pharma, Suncare Research, Informa, UpToDate and National Psoriasis Foundation. He is founder and majority owner of www.DrScore.com and founder and part owner of Causa Research, a company dedicated to enhancing patients’ adherence to treatment.

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