LONG-TERM SAFETY OF ISOTRETINOIN AS A TREATMENT FOR ACNE-VULGARIS

We assessed possible long-term side-effects of isotretinoin therapy in 720 patients who had received one or more courses of treatment, and h ad a mean follow-up period of 4.9 years (range 2-12 years). Most patie nts (442) had received a total cumulative dose of 120-200 mg/kg body w eight. One hundred and sixty-two patients received a cumulative dose o f < 120 mg/kg body weight, and 116 received a cumulative dose > 200 mg /kg. Fifty-two patients (7.2%) reported persistent symptoms during the follow-up period. No correlation was found between age, sex, cumulati ve dose, or number of courses of isotretinoin and occurrence of report ed possible side-effects. The reported symptoms were predominantly mus culoskeletal (2%) or mucocutaneous (4.8%), and were mild in all cases. Xeroderma, dry eye syndrome, arthralgia, and possible exacerbation of eczema, were considered to be infrequent but probable long-term side- effects. The findings of this study indicate that isotretinoin in the treatment of acne is a safe drug, with no serious long-term side-effec ts.