Accutane Basics

Isotretinoin (trade name Accutane)

Isotretinoin is generally referred to as Accutane, the trade name under which it was first introduced.  Isotretinoin (i.e., Accutane) is a medication used for the treatment of severe cystic acne. Accutane has been available since 1971 and has changed the field in terms of the ability to control severe cystic acne.

Oral isotretinoin (often called Accutane) is marketed under various trade names, including Roaccutane (Hoffman-La Roche), Amnesteem (Mylan), Claravis (Barr), Clarus (PremPharm), Decutan (Actavis), Isotane (Pacific Pharmaceuticals), Izotek (BlauFarma), Oratane (Genepharm Australasia), ISOTRET (Liva Healthcare Ltd.) or Sotret (Ranbaxy). Accutane is the most powerful medicine available for the treatment of severe cystic acne.

Dosage of isotretinoin varies by country.  Relatively high dosages of isotretinoin are generally used in treatment in the United States (1 mg per kg for 5 months or a cumulative dosage of 120-150 mg per kg).  Lower dosages are often used outside the U.S. One study conducted in Israel found that treatment with 20mg per day over 6 months resolved Acne for a large majority of patients that suffered from "moderate" acne. Follow up was conducted during the 4 years following treatment. Unfortunately, limited research exists regarding low dosage treatment and what research does exist suggest a much higher rate of relapse for low dosage treatment.

In February 2002, Roche's patents for Accutane expired and there are now many other companies selling cheaper generic versions of the drug.  On June 29, 2009, Roche Pharmaceuticals, the original creator and distributor of Accutane, officially discontinued both the manufacture and distribution of their Accutane brand in the United States due to what the company described as business reasons related to low market share (below 5 percent) coupled with the high cost of defending personal-injury lawsuits brought by some patients prescribed the drug.  Generic isotretinoin remains widely available in the United States through various manufacturers.  Roche USA continues to defend Accutane and claims to have treated over 13 million patients since its introduction in 1982.   F. Hoffmann-La Roche Ltd. apparently will continue to manufacture and distribute Accutane outside of America.

Accutane was approved by the Food and Drug Administration ("FDA") in 1982 to treat recalcitrant nodular acne, a severe and disfiguring skin disease characterized by large, inflamed cystic lesions on the patient's face and back. Chemically, Accutane is isotretinoin, or 13-cis-retinoic acid. It is part of the family of drugs known as retinoids, vitamin A derivatives. Roche initially studied the use of retinoids as potential chemotherapy for the treatment of cancer. As a result of its research, Roche discovered that retinoids were effective in treating nodular acne. Although the exact "mechanism of action" for how Accutane works is unknown, Roche discovered that the drug was effective in suppressing the production of oil and waxy material produced in the sebaceous glands.

Nodular acne is caused by the accumulation of sebum under the skin, which ultimately ruptures the follicle wall, forming an inflamed nodule. Accutane was found to be highly effective in treating nodular acne that has been recalcitrant to standard treatments. Accutane is a teratogen, meaning that there is a high risk that if a woman takes the drug while pregnant, her child will be born with life-threatening birth defects. Additionally, common adverse effects from Accutane include dry skin, lips, and eyes, conjunctivitis, decreased night vision, muscle and joint aches, and elevated triglycerides.

The effect on sebum production is temporary.  However, remission of the disease can be "complete and prolonged," although relapse and the need for retreatment is common.  Anecdotal evidence and some studies have shown that only about 40% of patients treated with a full dose of Accutane experience a complete remission (i.e., cure) of their Acne.  Others need continuing treatment with topical treatments or antibiotics or retreatment with a second (or sometimes third) course of treatment. Nevertheless, Accutane remains the most powerful medicine available for the treatment of severe cystic acne.

In the case of lower doses of Accutane, the studies have shown relapse rates as high as 53% in patients 12 months after completion of a course at 0.5 mg/kg (and 63% in patients after completion of a course at 0.2 mg/kg). Hence, contrary to what many patients may hope, Accutane should be viewed more as another form of acne treatment for most, but not necessarily an acne cure.

Several scientific studies have concluded that isotretinoin is a possible cause of Crohn's Disease and Ulcerative colitis in some individuals. Three lawsuits in the United States that have gone to trial resulting in multi-million dollar judgments against the makers of isotretinoin; there are hundreds of additional cases pending. On appeal, many of these lawsuits have been reversed. Read more about pending Accutane litigation here.

The concurrent use of isotretinoin with tetracycline antibiotics or vitamin A supplementation is not recommended. Concurrent use of isotretinoin with tetracyclines significantly increases the risk of idiopathic intracranial hypertension. Concurrent intake of Vitamin A supplementation increases the risk of vitamin A toxicity.

 

 


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