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Accutane

Isotretinoin is a generic medication used for the treatment of severe acne and most commonly known under the brands Accutane and Roaccutane. It is a retinoid, meaning it is derived from vitamin A and is found naturally in the body, produced by the liver in small quantities. more...

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History

Prior to the development of isotretinoin, the mainstay treatment of severe acne was oral antibiotics such as the tetracyclines and erythromycin. While these drugs have proven efficacy, they worked against only one contributing factor of acne, Propionibacterium acnes bacteria. The antibiotics gradually became less effective over time as more resistant strains of the bacterium became prominent.

An early, effective treatment of acne was high doses of the fat soluble vitamin A. At these dose levels (sometimes 500,000 IU per day) effects such as reduced production of sebum and dry hair could be noticed. However the vitamin also had many other prominent side effects which inhibited its widespread use.

The development of the derivative of retinoic acid, isotretinoin (13-cis-retinoic acid), and its release in 1982 by Hoffmann-La Roche was a great step forward in the treatment of acne. The synthetic compound provided better therapeutic benefit than vitamin A, while also producing fewer side effects. In February 2002 Roche's patents for isotretinoin expired, there are now many other companies selling cheaper generic versions of the drug.

Today isotretinoin is usually prescribed after other acne treatments have failed to produce results. The treatment of acne usually begins with topicals, moves onto oral antibiotics (or a combination) and finally isotretinoin therapy. This is because other treatments, while less effective than isotretinoin, produce far fewer side effects.

Brand names

Isotretinoin is produced under many brand names by many manufacturers. It is available typically as 5 mg, 10 mg, 20 mg and (in the USA) 40 mg capsules.

Some brands of isotretinoin include:

  • Accure® by Alphapharm
  • Accutane® and Roaccutane® by Roche
  • Aknenormin® by Hermal
  • Amnesteem® by Mylan
  • Ciscutan® by Pelpharma
  • Claravis® by Barr
  • Isohexal® by Hexal Australia
  • Isotroin® by Cipla
  • Oratane® by Douglas Pharmaceuticals
  • Sotret® by Ranbaxy

Indications

Isotretinoin is indicated for treatment for a number of dermatological conditions, most commonly acne. It is generally not used as a first-line treatment due to the potential side effects. Antibiotics (such as the tetracyclines) are usually prescribed before isotretinoin.

Severe forms of acne (conglobata, fulminans and nodulocystic) as well as acne that scars can be successfully treated with isotretinoin.

Acne that has not responded to other treatment will usually respond to isotretinoin. Dysmorphophobic patients may also be prescribed isotretinoin.

Read more at Wikipedia.org


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Companies warned about unapproved accutane - Updates
From FDA Consumer, 11/1/03

The FDA has sent letters to several firms warning them to stop illegally selling an unapproved, mislabeled version of the acne drug Accutane (isotretinoin). The agency believes that this illegal practice may pose a serious health risk, and urges people not to use illegal foreign versions of the drug.

The illegal drugs include a gel version of Accutane, designed to be applied to the skin, which is sold only with foreign language labeling to American consumers through the Internet. Companies have sold the drug, which purports to be equivalent to Accutane, without requiring a prescription. Accutane can cause birth defects if taken by pregnant women, and is subject to a restrictive distribution program known as the System to Manage Accutane Related Teratogenicity (SMART) program. The term "teratogenicity" refers to the potential to cause birth defects.

Under the SMART program, only certain physicians may legally prescribe Accutane. In addition, the prescription must be filled within seven days, and it must have a yellow sticker that certifies the patient is not pregnant. Before starting the treatment regimen, the patient must be educated about the dangerous side effects associated with this drug product when it is improperly used.

Illegal Internet sales of Accutane reflect the dangers that Americans face when they buy foreign versions of U.S. drugs online. These sites are inherently risky because they bypass the strong risk-management program that the FDA has established to protect consumers.

COPYRIGHT 2003 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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