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Isotretinoin may cause ocular defects in patients with acne vulgaris

Patients who use isotretinoin, a highly effective treatment for acne vulgaris, should be educated about potential ocular problems associated with taking the drug, according to recent study results that reiterate previous warnings.

A retrospective cohort study in Israel of 14,682 young people (52.7% male) receiving isotretinoin was designed to evaluate whether it was harmful to users’ eyes. Prior studies have identified conjunctivitis and blepharitis as the primary adverse events (AEs) associated with isotretinoin use.

An Israeli HMO’s database records from 2000 through 2007 were searched to find individuals who had used isotretinoin. The study established two control groups of individuals who had not received isotretinoin; one control group comprised individuals with acne (n=14,682) and the other control group was acne-free (n=14,682). Those with diabetes mellitus, cancer, cardiovascular disease, or thyroid disorders before the index year were excluded from the study.

Individuals in the isotretinoin group were aged 14 to 20 years; they recently had just started using the drug and had two or more prescriptions dispensed at least 28 days apart.

The recommended isotretinoin dosage was 0.5 mg/kg daily to 1.0 mg/kg daily, up to a cumulative dose of 120 mg/kg to 150 mg/kg.

The most common AEs in the isotretinoin group within 1 year after the index date were conjunctivitis (n=1,223), chalazion (n=285), blepharitis (n=199), and dry eye (n=140).

Eye lubricants were required in the isotretinoin group by 5.1% of female participants and 3.4% of males, compared with <1.0% of both females and males in the group with acne who had not received isotretinoin.

Investigators said these results “underscore the importance of primary and secondary preventive measures.” They said it is important for practitioners who prescribe isotretinoin to be aware of potential eye defects in their patients and to prescribe ocular medications such as preservative-free artificial tears for these patients.

“To ensure early detection and treatment, it is important that patients and caregivers should be informed of the potential ocular AEs associated with isotretinoin use,” researchers concluded.