Accutane, also known as isotretinoin, is a synthetic form of vitamin A.  Accutane was originally developed for treating brain and pancreatic cancer because of its ability to kill rapidly dividing cells.  Oral Accutane is marketed under a number of names including Claravis, Decutan, Isotane, Oratane, and Isotret.  Accutane works by reducing sebum production by inducing apoptosis (programmed cell death) in sebaceous glands.

Because of the serious side effects associated with Accutane, it was intended to be used only to treat the most severe forms of acne.  Specifically, because of severe Accutane effects, Accutane was meant to be limited to those instances of acne that are disfiguring and scar forming and that are untreatable by other methods.  Unfortunately, the government found that 90% of women and nearly half the teens who took Accutane suffered only mild cases of acne.  The fact that Accutane has been grossly over-prescribed since its inception is one of the controversies surrounding this high-risk drug. 

Beginning in 2006, isotretinoin was placed under special prescribing requirements under a restricted distribution program approved by the FDA.  Under this program, named iPLEDGETM, isotretinoin could only be prescribed by physicians who were registered and activated by iPLEDGE, and could only be dispensed to patients who were registered and met all the requirements of iPLEDGE.

Accutane Recall 

In June 2009, Hoffman-La Roche, the manufacturer of Accutane, initiated a nationwide recall of Accutane.  The company decided to conduct an Accutane recall, citing generic competition and the growing costs of defending against Accutane lawsuits. Roche has since recalled Accutane in 11 additional countries, including France, Denmark, Austria, Germany, Portugal, Norway and Spain. Roche refused to acknowledge that the recall was precipitated by fears of Accutane effects.

Lawsuits over Accutane Effects

Roche has been faced with hundreds of lawsuits over Accutane effects, including many lawsuits concerning the link between Inflammatory Bowel Disease (IBD) and Accutane treatment.  Millions of dollars have already been awarded to some of these individuals, compensating them for medical bills, lost wages, and pain and suffering. 

According to Bloomberg News, Roche has lost 6 cases concerning Accutane effects that have gone to trial so far.  A New Jersey court awarded over $25 million in compensatory damages and $159,000 in medical expenses to an Alabama man by the name of Andrew McCarrell.  Mr. McCarrell reported that Hoffmann-La Roche failed to properly warn of Accutane effects.  Mr. McCarrell says he contracted Inflammatory Bowel Disease after taking Accutane.  He had five surgeries for Inflammatory Bowel Disease and finally had to have his colon removed. 

Accutane has been associated with Inflammatory Bowel Disease in patients without prior history of intestinal disorders and has been reported to persist after Accutane treatment has stopped. 

Accutane Lawyers

If you or a loved one have experienced Accutane effects, including symptoms of IBD, after being treated with Accutane, contact us for a free case evaluation.

Published November 17, 2011 by