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ACCUTANE (ISOTRETINOIN) CAPSULES: SPECIAL WARNINGS

Hearing Impairment

Impaired hearing has been reported in patients taking Isotretinoin (Accutane) capsules; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued. Mechanism(s) and causality for this event have not been established. Patients who experience tinnitus or hearing impairment should discontinue Accutane treatment and be referred for specialized care for further evaluation.

Hepatotoxicity

Clinical hepatitis considered to be possibly or probably related to Accutane therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been observed in approximately 15% of individuals treated during clinical trials, some of which normalized with dosage reduction or continued administration of the drug. If normalization does not readily occur or if hepatitis is suspected during treatment with Accutane (Isotretinoin) pills, the drug should be discontinued and the etiology further investigated.

Inflammatory Bowel Disease

Accutane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Isotretinoin (Accutane) pills treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately.

Vision Impairment

Visual problems should be carefully monitored. All Accutane patients experiencing visual difficulties should discontinue Isotretinoin (Accutane) treatment and have an ophthalmological examination.

Corneal Opacities

Corneal opacities have occurred in patients receiving Accutane for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization. The corneal opacities that have been observed in clinical trial patients treated with Accutane (Isotretinoin) capsules have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation of the drug.

Decreased Night Vision

Decreased night vision has been reported during Accutane therapy and in some instances the event has persisted after therapy was discontinued. Because the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.

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