Roaccutane (isotretinoin) PRECAUTIONS Information for Patients: Females of childbearing potential should be instructed that they must not be pregnant when Accutane therapy is initiated, and that they should use effective contraception while taking Accutane and for 1 month after Accutane has been stopped. They should also sign a consent form prior to beginning Accutane therapy

Roaccutane (isotretinoin) ADVERSE REACTIONS Clinical: Many of the side effects and adverse reactions seen or expected in patients receiving Accutane are similar to those described in patients taking high doses of vitamin A. The percentages of adverse reactions listed below reflect the total experience in Accutane studies, including investigational studies of disorders of keratinization, with the exception of those pertaining to dry skin and mucous membranes. These latter reflect the experience only in patients with nodular acne because reactions relating to dryness are more commonly recognized as adverse reactions in this disease. Included in this category are dry skin, skin fragility, pruritus, epistaxis, dry nose and dry mouth, which may be seen in up to 80% of nodular acne patients. The most frequent adverse reaction to Accutane is cheilitis, which occurs in over 90% of patients. A less frequent reaction was conjunctivitis (about 2 patients in 5). Skeletal hyperostosis has been observed on x-rays of patients treated with Accutane

Other types of bone abnormalities have also been reported; however, no causal relationship has been established. In the post-marketing period, a number of patients treated with Accutane have reported depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy (see WARNINGS ). Approximately 16% of patients treated with Accutane developed musculoskeletal symptoms (including arthralgia) during treatment. In general, these were mild to moderate and have occasionally required discontinuation of drug. Less frequently, transient pain in the chest has also been reported. These symptoms generally cleared rapidly after discontinuation of Accutane but in rare cases have persisted. Less than 1 patient in 10 experienced rash (including erythema, seborrhea and eczema); thinning of hair, which in rare cases has persisted. Approximately 1 patient in 20 experienced peeling of palms and soles, skin infections, nonspecific urogenital findings, nonspecific gastrointestinal symptoms, fatigue, headache and increased susceptibility to sunburn. Accutane has been associated with a number of cases of pseudotumor cerebri, some of which involved concomitant use of tetracyclines

The following CNS reactions have been reported and may bear no relationship to therapy -- seizures, emotional instability, dizziness, nervousness, drowsiness, malaise, weakness, insomnia, lethargy and paresthesias. The following reactions have been reported in less than 1% of patients and may bear no relationship to therapy -- changes in skin pigment (hypo- and hyperpigmentation), flushing, urticaria, bruising, disseminated herpes simplex, edema, hair problems (other than thinning), hirsutism, respiratory infections, weight loss, erythema nodosum, paronychia, nail dystrophy, bleeding and inflammation of the gums, abnormal menses, optic neuritis, photophobia, eye lid inflammation, arthritis, anemia, palpitation, tachycardia, lymphadenopathy, sweating, tinnitus and voice alteration. Reports of acne fulminans and vasculitis, including Wegener's granulomatosis, have been received, but no causal relationship to Accutane therapy has been established. In Accutane studies to date, of 72 patients who had normal pretreatment ophthalmological examinations, 5 developed corneal opacities while on Accutane (all 5 patients had a disorder of keratinization). Corneal opacities have also been reported in nodular acne patients treated with Accutane

Dry eyes and decrease in night vision have been reported and in rare instances have persisted (see WARNINGS ). Cataracts, keratitis and visual disturbances have also been reported. Accutane has been temporally associated with inflammatory bowel disease (see WARNINGS ). Delayed wound healing has been reported. As may be seen with healing inflammatory acne lesions, an occasional exaggerated healing response, manifested by exuberant granulation tissue with crusting, has been reported in patients receiving therapy with Accutane. Pyogenic granuloma has also been diagnosed in a number of cases.

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