Accutane, manufactured by the pharmaceutical company Roche, has continued to be a source of medical and regulatory problems.  The FDA placed the acne drug Accutane in the iPledge program to help protect against birth defects.  Many Accutane lawsuits have been filed.  Roche has removed Accutane from the market.

FDA Placed Accutane in the iPledge Program Due to Birth Defects

The acne drug Accutane was placed on the market in 1982.  Early on, physicians and patients reported Accutane effects that involved suicide, birth defects, and inflammatory bowel disease (including ulcerative colitis and Crohn’s disease).  Accutane effects have plagued the medical community as well as the FDA.  Early on, problems were reported by female patients who miscarried or had abnormally formed babies.  The risk of birth defects in the general population runs between 3-5% whereas women who had been on Accutane therapy had a 30% risk.  The FDA responded by strengthening guidelines for the proper use of Accutane as well as generic forms of the drug such as Amnesteem, Clarvis, and Sotret.  The FDA now requires that women and their physicians be properly educated regarding the use of this drug and also requires that women and their physicians register with the pharmaceutical company (known as the iPledge program).  Women must also take a pregnancy test and use two different forms of birth control while on Accutane therapy.  The FDA felt this was the best way of insuring that healthcare providers and patients are properly informed about Accutane effects in a regulated way.

Roche Faces Many Lawsuits for Accutane Side Effects

A Florida resident filed an Accutane lawsuit claiming that the drug generated inflammatory bowel disease.  In 2008, this Florida resident was awarded $10.5 million  for suffering with inflammatory bowel disease generated by Accutane.  Later that year, three other users of Accutane who had also developed inflammatory bowel disease were compensated $13 million.  Roche has paid out many millions of dollars in compensation to victims of Accutane effects. 

In 2009, Roche removed Accutane from the market in the United States and a number of other countries.  Roche indicated that they recalled Accutane due to cost competition from its generic forms and the costs associated with the pending Accutane lawsuits.

If you have taken Accutane and believe you have experienced Accutane effects, you may be entitled to compensation for lost wages, pain and suffering, and hospital costs.  You might want to contact an attorney about Accutane lawsuits 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 effects or Accutane lawsuits please visit

Published November 17, 2011 by