Accutane Prescribing Patterns by Sex
The evidence does not support that females are prescribed Accutane (isotretinoin) less often than males; in fact, the data demonstrates that females represent a substantial and increasing proportion of isotretinoin users, with approximately 2.5 per 1,000 reproductive-aged women exposed to Accutane in 1999, representing more than a doubling over the preceding decade 1.
Current Prescribing Patterns
Females constitute a significant portion of isotretinoin prescriptions despite the drug's teratogenic risks:
The estimated number of Accutane prescriptions for reproductive-aged women more than doubled over a 10-year period through 1999, making isotretinoin the most widely used teratogenic drug in the United States 1
From 1989 to October 1999, approximately 454,273 reproductive-aged women enrolled in the Boston University Accutane Survey (BUAS), representing an estimated 38-40% of all reproductive-aged women taking isotretinoin during this period 2
The increase in female isotretinoin use was potentially exacerbated by direct-to-consumer advertising campaigns that began in 1996 with print advertisements, expanded to television and radio in 1997, and reached nationwide coverage by 1998 1, 2
Clinical Context and Prescribing Requirements
The American Academy of Dermatology establishes clear indications for isotretinoin therapy that apply regardless of sex:
Severe recalcitrant nodular acne is the primary FDA-approved indication 3
Any acne causing psychosocial burden or active scarring, regardless of objective severity, constitutes an appropriate indication for isotretinoin therapy 3
Acne unresponsive to standard oral and topical therapies warrants consideration of isotretinoin 3
Mandatory Pregnancy Prevention Requirements for Females
The prescribing of isotretinoin to females of childbearing potential requires strict adherence to pregnancy prevention protocols:
Two forms of effective contraception must be used simultaneously starting 4 weeks before therapy, throughout treatment, and continuing for 3 years after discontinuation 3
Pregnancy testing is mandatory within 2 weeks prior to starting therapy and monthly during treatment 3
Patients must avoid alcohol completely, as it converts isotretinoin to etretinate, which has a significantly longer elimination half-life and extends the required contraception period 3
Pregnancy is an absolute contraindication for isotretinoin therapy 3
Evidence of Continued Pregnancy Exposures
Despite pregnancy prevention programs, isotretinoin-exposed pregnancies continue to occur among female patients:
Approximately 900 pregnancies occurred among BUAS enrollees during 1989-1998, despite the implementation of a pregnancy prevention program in 1988 2
In a California study of 14 women with recent Accutane-exposed pregnancies, 8 of 14 women used no contraception at the time of exposure, and 13 of 14 did not use two forms of contraception as required 1
Four of the 14 women did not have pregnancy tests before starting Accutane, and none reported seeing all pregnancy prevention program components 1
These 14 pregnancies resulted in four live infants without apparent defects, one live-born infant with multiple defects, four spontaneous abortions, and five induced abortions 1
Contrast with Other Teratogenic Medications
For comparison, acitretin (another teratogenic retinoid) shows markedly different prescribing patterns in women of childbearing potential:
From 1996-2009, the National Ambulatory Medical Care Survey contained only one record of a female patient under age 50 being prescribed acitretin, corresponding to an estimated 2.3% of all psoriasis patients prescribed acitretin 4
This demonstrates that acitretin is used at most infrequently in women of reproductive potential, likely due to its even longer teratogenic risk period and availability of alternative treatments 4
Common Pitfalls in Isotretinoin Prescribing
Physicians must avoid these critical errors when prescribing isotretinoin to females:
Failing to verify that two forms of contraception are being used simultaneously, not just one method 1
Not obtaining pregnancy tests within the required 2-week window before starting therapy 1
Inadequate patient education about all components of the pregnancy prevention program 1
Prescribing isotretinoin for indications beyond those established by guidelines, which unnecessarily increases the number of exposed pregnancies 5