Date of Award
T. Kristopher Harrell
Isotretinoin, most often recognized by the brand name Accutane®, is regarded by many patients and prescribers as the miracle cure for acne. Its unsurpassed efficacy is paired with serious risk of adverse events and birth defects, which poses ethical questions regarding its safety and necessity. Its regulatory history established precedent in Food and Drug Administration Risk Evaluation and Mitigation Strategies and brought awareness to the sharp dangers of teratogenic drug use.
This medication came as a breakthrough solution to patients that suffered years of unsuccessful regimens for the treatment of acne vulgaris. Some question the risk-benefit evaluation of such a toxic drug for acne. It was noted in Archives of Family Medicine that “although acne is not a life-threatening disease, it has significant physical and psychological ramifications such as permanent scarring, poor self-image, social inhibition, depression and anxiety” (Thiboutot). Significant health implications press the need for such an effective drug. Accutane® and isotretinoin generic drugs have changed the lives of over two million patients (AOCD).
Despite the remarkable success, the significant dangers must not be overlooked. Measures have been put in place such as a Black Box warning, categorization as Category X pregnancy risk, and the REMS program “iPLEDGE”, but significant adverse events and pregnancy issues continue to be reported. Regulatory history and extreme legal backlash quickly caused the brand-name Accutane® by Hoffmann-La Roche to be taken off the market, but numerous isotretinoin generic formulations continue to be profitable and prescribed to patients daily. Although many still confuse isotretinoin drugs and refer to all of these medications as “Accutane®”, this drug is no longer distributed or prescribed. When a patient says they are taking “Accutane®”, they are most likely receiving an isotretinoin drug almost identical to Accutane®, but produced by a different company. The household name recognition that Accutane® achieved after litigation remains in dermatological vocabulary although it has been discontinued.
The REMS of isotretinoin aims to (1) to prevent fetal exposure and (2) to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions (FDA). The stringent regulations of this drug and its implications on the pharmacological safety environment warrants scrutinous evaluation and review. How has the FDA, the pharmaceutical industry, and the healthcare industry, in general, responded to high risk drugs (like Accutane®) with significant adverse events in recent years?
Betts, Bridget A., "Does It Get Any Worse Than Acne? It Does, Actually. An In-Depth Review of Accutane’s Regulatory History." (2020). Honors Theses. 1344.
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