Brand Discontinued in US (generic available)

Indicated for:

Severe Recalcitrant Nodular Acne:

• The treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.

Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.

Because of Accutane’s teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE. Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program.

Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.

Accutane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances.

Impaired hearing has been reported in patients taking Accutane; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued.

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 Accutane treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately.

Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been reported. Accutane should be stopped if hypertriglyceridemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur.

Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Accutane. Marked elevations of serum triglycerides were reported in approximately 25% of patients receiving Accutane in clinical trials. In addition, approximately 15% developed a decrease in high-density lipoproteins and about 7% showed an increase in cholesterol levels.

Clinical hepatitis considered to be possibly or probably related to Accutane therapy has been reported.

Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been seen in the Accutane population. While causality to Accutane has not been established, an effect cannot be ruled out.

A high prevalence of skeletal hyperostosis was noted in clinical trials for disorders of keratinization with a mean dose of 2.24 mg/kg/day.

There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of Accutane.

Decreased night vision has been reported during Accutane therapy and in some instances the event has persisted after therapy was discontinued.

Wax epilation and skin resurfacing procedures (such as dermabrasion, laser) should be avoided during Accutane therapy and for at least 6 months thereafter due to the possibility of scarring.

Neutropenia and rare cases of agranulocytosis have been reported. Accutane should be discontinued if clinically significant decreases in white cell counts occur.

Vitamin A: Because of the relationship of Accutane to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.

Tetracyclines: Concomitant treatment with Accutane and tetracyclines should be avoided because Accutane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.

Phenytoin: Accutane has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers.

Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis.

Female patients of childbearing potential must have negative results from 2 urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial Accutane prescription. The first test is obtained by the prescriber when the decision is made to pursue qualification of the patient for Accutane (a screening test). The second pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual period immediately preceding the beginning of Accutane therapy. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse (without using 2 effective forms of contraception).

It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive Accutane.

GoToSource

• Mild to moderate rosacea, cellulitis of the scalp and grover’s disease. GoToSource

• Use in patients under the age of 12. GoToSource

• Use as a first-line medication and treatment of mild to moderate cases of acne. GoToSource

• Cornification and use in chemoprevention of skin cancer. GoToSource 

• Psoriasis and psoriatic arthritis. GoToSource

• Recalcitrant condylomata acuminata of the cervix. GoToSource

• High dose maintenance therapy in patients with high grade glioma in complete remission after first line multimodal treatment. GoToSource

• Redifferentiation of thyroid cancer. GoToSource

• Stage IIIB cervical cancer. GoToSource

• Recurrent glioblastoma multiforme. GoToSource

• Progressive measurable metastatic renal cell carcinoma. GoToSource

• Prurigo pigmentosa and reticular hyperpigmentation. GoToSource

• Generalized granuloma annulare with myelodysplastic syndrome. GoToSource

• Follicular mucinosis. GoToSource

• Condyloma acuminatum. GoToSource

• Keratoacanthoma centrifugum marginatum. GoToSource

Decreased bone density and increased risk of fractures. GoToSource

Dryness of skin, lips and mucous membranes, cheilitis (lip inflammation), skin fragility, skin peeling, rash, epistaxis (nose bleed), diffuse alopecia (hair loss), hyperlipidemia (high levels of fats or lipids in the blood), headaches, myalgia (muscle pain), back pain, cataracts, optic neuritis (inflammation of optic nerve), menstrual disturbances, inflammatory bowel disease, pancreatitis (inflammation of pancreas), hepatitis (liver inflammation), idiopathic intracranial hypertension (increased pressure around the brain), skeletal hyperostosis (skeletal disorder characterised by unusual new bone formation), psychosis, raised blood glucose level, increased erythrocyte sedimentation rate, fatigue, neutropenia (low white blood count) and thrombocytopenia (low blood platelet count). GoToSource

Suicide or suicide attempts. GoToSource

Birth defects and mental retardation resulting from fetuses exposed to Accutane. Women who are pregnant or who might become pregnant should not take this drug. GoToSource

Pseudotumor cerebri and impaired night vision. GoToSource

Elevated triglycerides and AST and ALT levels. GoToSource

Stevens-johnson syndrome and toxic epidermal necrolysis. GoToSource

Blepharoconjunctivitis, meibomitis, dry eye symptoms, contact lens intolerance, blurred vision, photodermatitis of the eyelids, corneal opacities, decreased visual acuity, abnormalities in visual field and retinal functions and papilledema. GoToSource  

Sacroiliitis (inflammation of the sacroiliac joint). GoToSource

Rheumatologic symptoms (joint pain and inflammation). GoToSource

Skeletal hyperostosis (calcification of ligaments where they attach to the spine). GoToSource

Lawsuits filed for birth defects, suicides, inflammatory bowel disease and pancreatitis.