Dermatologists’ Attitudes, Prescription, and Counseling Patterns for Isotretinoin: A Questionnaire-based Study
February 2015 | Volume 14 | Issue 2 | Original Article | 184 | Copyright © February 2015
Arielle R. Nagler MD1 and Seth J. Orlow MD PhD1
1The Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, NY
Isotretinoin, the most effective therapy for severe acne, has engendered controversy. These controversies impact dermatologists’
opinions of isotretinoin and prescription behaviors. This study was designed to characterize dermatologists’ opinions of controversies
surrounding isotretinoin, as well as counseling and prescribing practices. A 25-question survey was emailed to 7,013 dermatologists
included in a proprietary database (MBD, Inc.) and anonymous responses were collected. 591 board-certified dermatologists
participated. Thirty-seven percent of the responding dermatologists believe that isotretinoin may cause psychiatric disturbances.
Dermatologists’ opinions on this relationship did not significantly impact prescription practices in patients with history of depression
=0.056) or in patients being treated with an antidepressant (P
=0.118). A larger percentage of dermatologists surveyed believe
there is a causal relationship between isotretinoin and psychiatric disturbances than isotretinoin and IBD. Of the surveyed dermatologists,
2.7% believe there is a causal association between isotretinoin and inflammatory bowel disease IBD. In addition, physicians
with 20 or fewer years of experience, which included 50% of the responding dermatologists, were significantly less likely to have
read the patient brochure (P
=0.004), and more likely to prescribe isotretinoin to patients who had not failed systemic antibiotics (P
=0.015). This questionnaire also may highlight a practice gap, as more recently trained dermatologists appear less likely to require
failure of systemic antibiotics prior to initiating isotretinoin. J Drugs Dermatol.
Since its approval by the Food and Drug Administration
(FDA) in 1982, isotretinoin has been the most effective therapy
for severe acne. Isotretinoin inhibits sebaceous gland
function, decreases keratinization, reduces Propionibacterium
acnes burden, and suppresses the inflammatory response.1,2 Isotretinoin is thought to be a reasonably safe medication with
few common long-term adverse effects.1 The most common adverse
reactions include cheilitis, hypertriglyceridemia, and musculoskeletal
pain.3 Despite its efficacy in treating and inducing
prolonged remissions in acne, isotretinoin’s use is limited by
a number of proven and potential adverse reactions or warnings.
These include the known teratogenicity of isotretinoin, the
iPLEDGE registration program, as well as isotretinoin’s association
with psychiatric disturbances and IBD.
Isotretinoin, a category X medication, is absolutely contraindicated
in pregnancy. Created to decrease the frequency
of pregnancy-related adverse events, iPLEDGE requires patient,
physician and pharmacy registration, online verification
of compliance, and monthly laboratory evidence of negative
pregnancy status. The program includes an extensive patient
introductory brochure containing a detailed informed consent.
The package-insert displays a bolded warning regarding an
association between isotretinoin and psychiatric disturbances,
predominantly depression and suicidality. The “Warnings”
section describes an association with IBD. Whether there is
a causal relationship between isotretinoin and psychiatric
changes or IBD is debated in the medical literature and laymedia.
Moreover, the association between isotretinoin and
IBD is the subject of mass tort litigation. As a result, despite
conflicting and inconclusive data, these controversies likely
influence dermatologists’ opinions and practices with regards
to isotretinoin counseling and prescribing. This survey was
designed to investigate dermatologists’ opinions regarding
certain controversies surrounding isotretinoin, and how these
controversies influence prescribing and counseling.
A 25-question survey was distributed to 7,013 dermatologists
in a proprietary database (D. Kehrer, MBD, Inc.). Emails with
an explanation of the study, an invitation to complete the questionnaire,
and an embedded link to the survey were distributed.
The questionnaire was administered through SurveyMonkey,
a web–based survey tool. Responses were collected from Oc-