title: Long-term safety of isotretinoin as a treatment for acne vulgaris.
abstract: We assessed possible long-term side-effects of isotretinoin therapy in 720 patients who had received one or more courses of treatment, and had a mean follow-up period of 4.9 years (range 2-12 years). Most patients (442) had received a total cumulative dose of 120-200 mg/kg body weight. One hundred and sixty-two patients received a cumulative dose of < 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, cumulative dose, or number of courses of isotretinoin and occurrence of reported possible side-effects. The reported symptoms were predominantly musculoskeletal (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-effects.
authors.affiliation: Department of Dermatology, General Infirmary at Leeds, U.K.
authors.forename: V
authors.initials: V
authors.lastname: Goulden
authors.forename: A M
authors.initials: AM
authors.lastname: Layton
authors.forename: W J
authors.initials: WJ
authors.lastname: Cunliffe
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D004485:Eczema / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007057:Ichthyosis / Q000139:chemically induced; D015474:Isotretinoin / Q000009:adverse effects*; D007592:Joint Diseases / Q000139:chemically induced; D008134:Long-Term Care; D008297:Male; D013997:Time Factors
chemical_list: D015474:Isotretinoin