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.