Isotretinoin Lab Monitoring: How Much is Too Much?
Isotretinoin (13-cis-retinoinoic acid) is a dermatology mainstay for patients suffering with
persistent, refractory nodulocystic acne. Approved by the United States Food and Drug
Administration (FDA) in May of 1982 1 for severe recalcitrant nodular acne, this medication
ushered in new era of acne therapeutics with the potential to provide almost complete clearance
and remission of acne lesions. 2 Monthly visits required from ipledge allow qualified prescribers
to ascertain side effects, evaluate progress, and monitor lab values. Due to teratogenicity risks,
this national monitoring program requires monthly pregnancy-testing requirements for those of
childbearing potential, but other serum lab values, and frequency of testing, is often debated.
A 2022 JAMA Dermatology article suggests that there may be little evidence to support
frequent lab monitoring because most abnormalities are mild, transient, and rarely impact
treatment course. 3 This Delphi consensus study (a systematic process of forecasting using the
collective opinion of panel members) administered four rounds of anonymous electronic surveys
to 22 dermatologist-acne experts from five continents (mean 24 years of practice). Consensus
was achieved for checking ALT and triglycerides within a month prior to initiation (89.5% and
89.5% respectively), at peak dose (89.5%, 78.9%), but not monthly (76.2%, 84.2%), or after
treatment completion (73.7% both). Furthermore, group consensus (all >70%) reflected that CBC
and BMP do not have to be monitored at any point during treatment; as well as GGT (78.9%),
bilirubin (81.0%), albumin (72.7%), total protein (72.7%), low-density lipoprotein (73.7%),
high-density lipoprotein (73.7%), or C-reactive protein (77.3%). 3 These parameters only apply to
healthy patients without underlying abnormalities, preexisting conditions, or clinical context
warranting further investigation. Assessing for mental health side effects was not addressed.
In short, outside of pregnancy lab requirements, an expert panel recommends ALT and
triglycerides monitoring only at baseline and 1 month after reaching peak dose of isotretinoin.
All other lab values are not recommended for healthy individuals. Reducing the number of
venipunctures may improving the overall experience isotretinoin patients. The key is ongoing
assessment of risks, comorbidities, and patient complaints in order to offer evidence-based
recommendations.
References
1.(httpy/www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetylnformationfohttps://www.
econsultie.net/mm/main/apps/index.mplrPatientsandProviders/ucm094305.htm Accutane
FDA information.
Justin Love MPAS, PA-C, resides in the blue zone of Loma Linda, CA. He works for Loma Linda University Department of Dermatology. In his spare time, he enjoys any ocean-related activities and spending time with his family.