May 1, 2010

The Swiss pharmaceutical company Hoffman-La Roche is the maker of the prescription drug Accutane that is used in the treatment of severe cystic acne.  This drug was introduced to the market in 1982 and has been a source of serious medical and regulatory controversy.  Reported Accutane side effects involve Irritable Bowel Syndrome, birth defects, suicide, and skin disease.

The FDA was especially alarmed about the increased risk of birth defects with women taking Accutane.  Reports indicated that women taking Accutane had a 30% risk of birth defects.  Birth defects in the general population run between 3-5%.  In response to this large increase in risk, the FDA established a special program called the iPledge Program to protect women of childbearing age.  This program requires that women must register in the program, sign agreements to use birth control, and undergo pregnancy testing before, during, and after taking Accutane.  These patients must read all program brochures and agreements and sign a risk management document.  The iPledge program applies to Accutane as well as its generic forms, such as Amnesteem, Clarvis, and Sotret, and was designed to decrease the risk of birth defects associated with this acne drug. 

In 2007, the FDA posted a web page warning consumers about buying Accutane and its generics over the Internet without a prescription because of Accutane’s association with birth defects.  In fact, distribution of Accutane and generics outside of the iPledge program is in violation of FDA regulations for the safe use of this acne medication.

Roche Recalls Accutane:

In 2008, Roche was faced with a number of lawsuits involving Accutane side effects.  These lawsuits were associated with patients that had developed some form of Inflammatory Bowel Disease caused by Accutane.  Juries found that Roche did not inform consumers and physicians about the dangers of taking Accutane.  Roche has paid out millions of dollars due to Accutane side effects.

Health Canada has reported a number Accutane side effects that involve severe skin reactions known as Stevens-Johnson Syndrome (SJS).  This disease causes skin to burn from the inside out producing severe blisters that may allow the skin to separate from the body.  When this skin disease spreads to more than 30% of the body the condition is known as Toxic Epidermal Necrolysis (TEN), which is quite often fatal.  Treatment requires an Intensive Care Unit or Burn Unit.

On June 26, 2009, Roche took Accutane off the United States market and a number of other countries due to its possible link to Inflammatory Bowel Disease, psychological side effects, and birth defects.  Roche is faced with hundreds of lawsuits relating to these side effects and perhaps more to come.

If you have taken Accutane and believe you have experienced Accutane side effects you may be entitled to compensation for lost wages, pain and suffering, and hospital costs.  You might want to contact a lawyer about Accutane Recall to see if you qualify for a lawsuit.


Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research.  Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising.  To learn more about Accutane side effects or Accutane Recall please visit  

Published November 17, 2011 by