In this brief communication, JDD authors T. Roxana Ghadimi BS, Michael J. Martinez BS, and Evan A. Rieder MD present self-reported long-term, remote side effects to isotretinoin that dermatologists must be aware of.
INTRODUCTION
Isotretinoin is considered the gold standard treatment for severe nodulocystic acne, though it has been the subject of controversy in the media for concerns related to adverse psychiatric effects. In 2005, the FDA issued a black box warning for suicide, depression, aggression, and psychosis.1 However, repeated high quality studies have found no association between isotretinoin and psychiatric disorders.2
Isotretinoin’s side effect profile is well-documented and includes xeroderma, teratogenicity, psychiatric, gastrointestinal, and neurological symptoms.3 There has been little evidence demonstrating long-term side effects beyond effects on acne and sebum production. Nevertheless, long-term side effects associated with isotretinoin are discussed on social media platforms, such as the Facebook page “Accutane Survivors, Roaccutane, Isotretinoin Injuries & Side Effects” which contains approximately 12,000 members.
The YouTube channel, Life After Accutane, contains seven video interviews about long-term side effects attributed to isotretinoin.
The seven interviews were independently and qualitatively analyzed by two authors to identify self-reported short-term and long-term side effects attributed to isotretinoin therapy. Consensus discussion led to the organization of reported symptoms and common themes according to thematic analysis research protocols.4
Table 1 contains important interviewee demographics and treatment course features. Table 2 contains self-reported short- and long-term side effects.
Six interviewees stopped taking isotretinoin before the end of their treatment course due to various side effects, most commonly psychiatric symptoms (4/7). For all interviewees, symptoms that led to medication termination were reported to persist after stopping isotretinoin. Every interviewee also reported at least one novel symptom which began only after stopping the medication, including joint pain, irritable bowel syndrome (IBS), and visual disturbances.
Reported long-term symptoms that either persisted after stopping isotretinoin or started after stopping isotretinoin included dermatologic symptoms (6/7) (dry skin and hair), psychiatric symptoms (7/7) (depression and anxiety), gastrointestinal symptoms (6/7) (IBS and constipation), ocular symptoms (6/7) (dry eyes and visual disturbances), neurologic symptoms (4/7) (brain fog and fatigue), musculoskeletal symptoms (4/7) (joint pain and myalgias), and sexual dysfunction (4/7). Psychiatric symptoms were the most common long-term complaint. Two individuals reported admission into a psychiatric facility after early termination of an isotretinoin course.
It is uncertain how symptoms experienced by interviewees years later could be attributed to isotretinoin, as its elimination half-life is about 20 hours.5 Age is a confounding factor to consider, as individuals commonly experience onset of both acne and multiple common psychiatric disorders during adolescence and early adulthood. Though there is insufficient information to posit any diagnoses, all interviewees had symptoms concerning somatic symptom disorder.
This is the first evidence of self-reported long-term, remote side effects to isotretinoin, including sexual, neuropsychiatric, and gastrointestinal dysfunction. With growing social media discussion and interest in skin care and disease, dermatologists must be aware of these individuals. Further research on the validity of self-reported long-term side effects will allow both physicians and patients to better understand individual vulnerabilities to isotretinoin.
DISCLOSURES
The authors have no conflicts of interest to declare. The article has no funding source.
IRB approval status: Not applicable – IRB Exempt.
REFERENCES
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- Isotretinoin capsule information. FDA. Available at: https://www.fda. gov/drugs/postmarket-drug-safety-information-patients-and-providers/ isotretinoin-capsule-information. Accessed December 20, 2021.
- Singer S, Tkachenko E, Sharma P, et al. Psychiatric adverse events in patients taking isotretinoin as reported in a food and drug administration database from 1997 to 2017. JAMA Dermatol. 2019 Oct;155(10):1162-1166. doi: 10.1001/jamadermatol.2019.1416.
- Accutane [package insert]. Nutley, NJ: Roche Laboratories Inc; 2000.
- Thomas J, Harden A. Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Med Res Methodol. 2008;8:45. doi:10.1186/1471-2288-8-45.
- Wiegand UW, Chou RC. Pharmacokinetics of oral isotretinoin. J Am Acad Dermatol. 1998;39(2):S8-12. doi: 10.1016/s0190-9622(98)70438-4.
Source
Ghadimi, T. R., Martinez, M., & Rieder, E. (2023). Self-Reported Long-Term Side Effects of Isotretinoin: A Case Series. Journal of Drugs in Dermatology: JDD, 22(4), 423-424.
Adapted from original article for length and style.
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