Historical Prescribing Patterns of Accutane by Sex
Yes, women have historically been prescribed Accutane (isotretinoin) less often than men, and this gender disparity persists despite regulatory changes intended to improve access.
Evidence of Gender Disparity in Isotretinoin Prescribing
Historical Underrepresentation
Female patients seeking isotretinoin have historically been prescribed the medication less than male patients, a pattern that has persisted over decades 1
During the COVID-19 pandemic period, male predominance of isotretinoin prescriptions was even greater compared to pre-pandemic periods, with odds ratios of 4.13 versus 2.86, indicating worsening rather than improvement in the gender gap 1
Contributing Factors to Lower Female Prescribing
The primary driver of this disparity stems from the teratogenic risk of isotretinoin and the regulatory burden placed disproportionately on women of childbearing potential:
The iPLEDGE risk mitigation system requires all patients with childbearing potential to complete monthly pregnancy testing in addition to monthly follow-up visits, creating substantial barriers that male patients do not face 1
Female patients are disproportionately affected by iPLEDGE-related barriers, which include mandatory contraceptive counseling, pregnancy testing, and more stringent documentation requirements 1
Between 1989 and October 1999, approximately 454,273 reproductive-aged women enrolled in the Boston University Accutane Survey, yet approximately 900 pregnancies still occurred among enrollees during 1989-1998, highlighting the complexity of preventing exposures despite extensive prevention programs 2
Persistence Despite Regulatory Flexibility
Even with the introduction of telehealth and at-home pregnancy testing during the COVID-19 pandemic—changes specifically designed to reduce barriers—gender inequity in receiving isotretinoin treatment persists 1
Male patients were more likely to utilize telehealth compared to in-person visits for isotretinoin follow-up relative to female patients (odds ratios: 6.00 vs. 3.62), suggesting that even when barriers are reduced, women face additional obstacles 1
Clinical Context
Teratogenic Risk and Regulatory Response
Isotretinoin is a known human teratogen that can cause multiple major malformations including craniofacial, cardiac, thymic, and central nervous system abnormalities when exposure occurs during the first trimester of pregnancy 2
The manufacturer began a pregnancy-prevention program in 1988 that included educational materials and offered women reimbursement for contraceptive counseling, yet exposed pregnancies continued to occur 2
Broader Pattern of Sex-Related Prescribing Disparities
This pattern with isotretinoin reflects a broader phenomenon in medicine where women are less often prescribed guideline-recommended medications and when prescribed, they tend to receive suboptimal doses 3
Common Pitfalls
Assuming that regulatory safeguards designed to protect women from teratogenic risk do not create prescribing barriers—the evidence clearly shows these systems, while necessary, have resulted in reduced access for female patients 1
Believing that telehealth and remote monitoring would eliminate the gender gap—data from the pandemic period demonstrates that even with these flexibilities, male patients received isotretinoin at significantly higher rates 1
Failing to recognize that the monthly iPLEDGE requirements create a cumulative burden that may lead prescribers to preferentially offer isotretinoin to male patients who face fewer regulatory hurdles 1