Standardized laboratory monitoring with use of isotretinoin in acne

• Published in: Journal of the American Academy of Dermatology Vol. 75; no. 2; pp. 323 - 328
• Main Authors: Hansen, Timothy J., MD, Lucking, SaraMarian, MD, Miller, Jeffrey J., MD, MBA, Kirby, Joslyn S., MD, MPH, Thiboutot, Diane M., MD, Zaenglein, Andrea L., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-08-2016
• Subjects: acne; Acne Vulgaris - drug therapy; Adolescent; Adult; Alanine Transaminase - blood; Child; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Dermatology; Female; Humans; hypercholesterolemia; Hypercholesterolemia - chemically induced; hypertriglyceridemia; Hypertriglyceridemia - chemically induced; isotretinoin; Isotretinoin - adverse effects; Isotretinoin - therapeutic use; laboratory monitoring; leukopenia; Leukopenia - chemically induced; Liver - drug effects; Liver - enzymology; Liver Function Tests; Male; Middle Aged; thrombocytopenia; Thrombocytopenia - chemically induced; transaminitis; Young Adult; isotretinoin; complete blood cell count; FDA; thrombocytopenia; CBC; hypertriglyceridemia; alanine aminotransferase; ALT; laboratory monitoring; hypercholesterolemia; leukopenia; acne; transaminitis; Food and Drug Administration
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2016.03.019

Background Laboratory monitoring for adverse effects to isotretinoin occurs with variability. Standardization of laboratory monitoring practices represents an opportunity to improve quality of care. Objective We sought to develop an evidence-based approach to laboratory monitoring of patients receiving isotretinoin therapy for acne. Methods We reviewed laboratory data from 515 patients with acne undergoing 574 courses of isotretinoin from March 2003 to July 2011. Frequency, timing, and severity of abnormalities were determined. Results Clinically insignificant leukopenia or thrombocytopenia occurred in 1.4% and 0.9% of patients, respectively. Elevated liver transaminases were detected infrequently and not significantly increased compared with baseline detection rates (1.9% vs 1.6% at baseline). Significant elevations occurred with triglyceride (19.3%) and cholesterol (22.8%) levels. The most severe abnormalities were grade 2 (moderate). Mean duration of treatment before abnormalities were detected was 56.3 days for hypertriglyceridemia, 61.9 days for alanine transaminitis, and 50.1 days for hypercholesterolemia. Limitations This was a single-center experience examining variable isotretinoin laboratory monitoring practices. Conclusions In healthy patients with normal baseline lipid panel and liver function test results, repeated studies should be performed after 2 months of isotretinoin therapy. If findings are normal, no further testing may be required. Routine complete blood cell count monitoring is not recommended.