Many adolescents taking oral isotretinoin for acne do not need monthly lab testing for lipid levels, hepatic function and complete blood cell count for the duration of treatment, according to a new study.
Isotretinoin, often sold as Accutane, has been associated with adverse effects like hyperlipidemia, thrombocytopenia and teratogenicity. Female patients taking isotretinoin must be monitored for pregnancy through the iPLEDGE program (https://www.ipledgeprogram.com). Researchers aimed to reconcile varying recommendations on the package insert and other studies as to the frequency of other testing.
“The findings of this study suggest that less frequent laboratory monitoring may be safe, with few missed high-risk laboratory changes, for many patients with acne who are receiving typical doses of isotretinoin,” according to the study “Laboratory Monitoring During Isotretinoin Therapy for Acne” (Lee YH, et al. JAMA Dermatol. Dec. 2, 2015, http://archderm.jamanetwork.com/article.aspx?articleid=2471551).
Researchers performed a systematic review as well as a meta-analysis of 26 studies. The studies included just over 1,500 children and adults who were taking at least 40 milligrams of oral isotretinoin daily for at least four weeks to treat acne vulgaris.
They found the drug is associated with a change in the mean value of white blood cell count and hepatic lipid panels, but “the mean changes across a patient group did not meet a priori criteria for high-risk and … the proportion of patients with laboratory abnormalities was low,” according to the study.
The findings fall in line with several previous studies that recommended laboratory monitoring only at baseline and for the first month or two.
“A decrease in the frequency of laboratory monitoring for some patients could help to decrease health care spending and potential anxiety-provoking blood sampling,” researchers said.
They recommended physicians use clinical judgment, taking into account baseline findings and concomitant conditions like pre-existing liver disease and metabolic syndrome.