Effective monitoring of isotretinoin safety in a pediatric dermatology population: A novel “patient symptom survey” approach

• Published in: Journal of the American Academy of Dermatology 2011-09, Vol.65 (3), p.517-524
• Main Authors: Hodgkiss-Harlow, Chelsea J., BS, Eichenfield, Lawrence F., MD, Dohil, Magdalene A., MD
• Format: Article
• Language: English
• Subjects: acne; Acne Vulgaris - drug therapy; Administration, Oral; Adolescent; Affect - drug effects; Child; Data Collection; depression; Depression - chemically induced; Dermatologic Agents - administration & dosage; Dermatologic Agents - adverse effects; Dermatology; Drug Monitoring; Female; Humans; isotretinoin; Isotretinoin - administration & dosage; Isotretinoin - adverse effects; Male; pediatrics; symptom survey; Young Adult
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2010.06.040

Background Assessment of adverse effects in pediatric patients on oral isotretinoin has not been standardized and the exact incidence is unknown. Objective Our goal was to determine the usefulness of an isotretinoin symptom survey as a screening tool for assessment and quantification of adverse effects, including psychiatric symptoms, during isotretinoin treatment in a pediatric population of different age groups. Methods We performed a retrospective chart review on a random sample of patients treated with isotretinoin at a tertiary pediatric dermatology clinic where patients completed an isotretinoin symptom survey at each visit. Responses were stratified by age group and psychiatric history. Results The charts of 102 patients, representing 123 courses of isotretinoin and 760 treatment-months, were reviewed. A total of 722 (95.0%) symptom surveys were complete and 38 (5.0%) were incomplete/missing. Recorded side effects were similar to published adult data; dry lips/dry skin were reported in 94.25% and 72.13% of treatment-months of isotretinoin, respectively. Psychiatric symptoms were reported in 1.65%, with no statistical difference between patients with or without a mental health history. Patients aged 11 to 15 years had similar side-effect profiles to those aged 16 to 21 years. Impaired night vision, nosebleeds, and dry/bloodshot eyes were more common in the older age group. Limitations This was a retrospective chart review, with known limitations. The study was performed at a tertiary referral center for pediatric dermatology, possibly allowing patient selection bias. Conclusions The isotretinoin symptom survey appears to be an effective screening tool to standardize monitoring of isotretinoin side effects in the pediatric population.