Consumerinjurylawyers : accutane recall : accutane warning

What is Accutane?

Accutane (isotretinoin generic) is a synthetic form of vitamin A.  This drug was developed by the pharmaceutical company Roche to treat severe nodular acne that is  unresponsive to other treatments.  It is also marketed under names such as Roaccutane, Amnesteem, Claravis and Sotret and was approved by the FDA in 1982.  Accutane is meant to treat only severe acne and is contrindicated for the treatment of mild acne because of the serious side effects associated with the drug.

Accutane has a Number of Risks Associated with it:

Accutane has been the subject of many warnings by the Food and Drug Administration (FDA) as well as consumer groups.  As early as 1983, the FDA required Roche to add an Accutane warning about the increased risk of birth defects in babies born to pregnant woman taking accutane.  By 1985, the first warnings were issued that Accutane may be associated with psychiatric complications.  In 2002, the FDA issued a MedWatch warning indicating that Accutane was associated with aggressive or violent behaviors.  Further reports of mental problems brought about new warnings in late 2005 which were more specific about Accutane being associated with depression and suicidal thoughts as well as suicide cases.  More recent reports provide for warnings of severe pancreatitis, inflammatory bowel disease, Crohn’s disease and ulcerative colitis that may require surgical removal of some of these organs.  If you are considering taking Accutane therapy, make sure you are well informed about the possible side effects and discuss this with you healthcare provider.  Make sure your doctor knows about your medical history and any problems you may have had with inflammatory bowel disease and psychiatric problems. 

Accutane has been Recalled:

The manufacturer of Accutane, Roche, initiated an Accutane recall in June of 2009 throughout the United States.  Roche claimed that the decision was based on financial reasons as its patent had expired and it was facing competition from generic brands as well as numerous Accutane lawsuits relating to the association between accutane therapy and inflammatory bowel disease. Accutane has been prescribed to more than 13 million people since it was placed on the market in 1982.  Interestingly, Accutane was originally used to treat patients who were on chemotherapy and was then observed to have great affects on severe acne.  Roche began marketing Accutane as an acne drug and it eventually became a major therapy for treating mild forms of acne, which was actually contraindicated due to severe side effects.  Accutane has now been recalled in France, Denmark, Austria, Germany, Portugal, Norway and Spain along with a few other countries.  There have been more than 5,000 personal injury lawsuits filed to date.  It is expected that many more lawsuits will be filed. 

Accutane lawsuits are not limited to inflammatory bowel disease but may also include birth defects, abdominal pain, central nervous damage, bone and muscle loss, pancreatitis and suicide.

If you have experienced Accutane side effects that involve Crohn’s disease, ulcerative colitis, depression, suicidal thoughts or any other Accutane related illness you may be entitled to financial compensation. Accutane lawsuits are currently being filed across the country.

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 warning or Accutane recall please visit

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