Accutane (Isotretinoin)

Accutane is derived from Vitamin A, which has been used to fight acne since 1930.  Different companies have developed numerous Vitamin-A based acne treatments over the years, including retin-A, isotretinoin and Accutane.

Before the release of Accutane, severe acne was primarily treated with oral antibiotics like tetracyclines and erythromycin. While these drugs worked for some patients, they were only effective against one of the bacteria that cause acne, Propionibacterium.  Over time, these antibiotics grew less and less effective as the bacteria developed more resistant strains.

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Another early method of treating acne was to use high doses of fat soluble vitamin A.  By using doses as high as 500,000 IU per day, researchers noticed lower rates of sebum, however, dry hair and other significant side effects kept the method from being used in a widespread manner.

Researchers from the National Institute of Health first studied isotretinoin in patients with skin cell disorders. They accidentally found that it also worked on patients with severe acne. Isotretinoin was registered in 1979 by Hoffman-LaRoche.  The development of isotretinoin was hailed as a major step forward in the treatment of acne at the time because the synthetic mix offered a better therapeutic benefit than high doses of vitamin A alone, while seemingly producing less side effects.

Roche officially released isotretinoin in the United States in 1982 as Accutane, and later released the drug in Europe in 1985 as Roaccutane.  The drug was marketed for those with severe acne as a treatment option once all other methods had failed.  Ironically though, the drug sold more than every other major acne treatment.

According to the Roche pharmaceuticals, Accutane has been used to treat approximately 5 million people in the United States and 12 million people worldwide since its release in 1982.  It was deemed effective in 85% of patients after one course of treatment, although others required a second course. Its use was split almost evenly between males and females.

In February of 2002 the patents that Roche held on Accutane expired and other companies began selling less expensive generic versions of the drug.

Roche discontinued production and sales of Accutane in the United States on June 29, 2009, citing poor market share and the rising cost of defending lawsuits filed by people claiming injuries after taking the medication.  However, at the time it was discontinued, the company estimated it was making approximately $1.2 billion per year from sales of Accutane in the United States alone.

Over 5,000 lawsuits have been filed so far against the maker of Accutane by people who claim the medication caused them severe side effects. Most of these lawsuits allege problems relating to Bowel Inflammation or Irritation, Crohns Disease, Ulcerative Colitis, Birth Defects, Hair Loss or Blindness.

Those injured by its use have recovered more than $33 million in damages for their medical bills, pain and future costs.