FacebookTwitterDiggGoogle BookmarksRedditRSS Feed

accutane2Accutane Warning Issued

Accutane, manufactured by Roche is an acne drug that has been associated with a number of side effects including gastrointestinal disorders that requires an Accutane Warning on all Accutane packaging.  Gastrointestinal diseases that can be generated by Accutane are inflammatory bowel disease (IBD) including ulcerative colitis (UC) and Crohn’s disease, stomach and/or esophagus ulcerations.  The FDA requires an Accutane Warning be placed on all packaging of this drug about IBD including Accutane Ulcerative Colitis.  These disorders can develop or even persist after Accutane therapy has been terminated.  The Accutane Warning lists symptoms to let you know if you are having internal organ or intestinal tract complications due to Accutane therapy.  These symptoms include:

  • Yellowing of the skin or eyes (jaundice, liver problems)
  • Trouble swallowing (esophagus irritations)
  • Recently initiated or worsening heartburn (acid reflux disease)
  • Dark colored urine (kidney problems)
  • Severe stomach or bowel pain
  • Rectal bleeding
  • Chronic diarrhea possibly with blood at a later stage

Accutane therapy should be terminated if you experience any of the above symptoms especially an induced Accutane Ulcerative Colitis or Crohn’s symptoms and make sure to contact your healthcare provider immediately. 

The Accutane Warning is listed in the medication guide that comes with your Accutane prescription and tells you that this acne drug has been associated with inflammatory bowel disease (IBD) and may cause an induced Accutane Ulcerative Colitis or Crohn’s disease.  This is true whether you have a previous history of IBD or not.  IBD is a general term that refers to two chronic and serious conditions that we have no cure for that includes Crohn’s disease and ulcerative colitis (UC).

Accutane and Crohns Disease

Briefly, Crohn’s disease is a type of inflammatory disease of the intestines that involves the lining of the digestive tract along the end of the small intestine (ileum) and the beginning of the large intestine (colon).  Symptoms of Crohn’s include stomach pain, severe diarrhea, vomiting and weight loss.  There is treatment available to manage symptoms but no known cure to date.  This disease can become quite debilitating leading to malnutrition.  If left untreated can become life-threatening.

Akin to Crohn’s disease is Ulcerative Colitis (UC) that is a chronic inflammation of the digestive tract involving the lining of the large intestine and rectum.  Symptoms of UC are similar to Crohn’s and in particular abdominal pain and diarrhea.  Rectal bleeding is common here.  There is treatment for an induced Accutane Ulcerative Colitis to maintain symptoms but there is no cure.  Accutane Ulcerative Colitis may require removal of parts of the large intestine in the worst case scenario. 

Esophagitis and esophageal ulcerations have also been reported to occur while on Accutane therapy.  Esophagitis is inflammation of the esophagus that generates problems swallowing along with chest pain.

Accutane has also been linked to Pancreatitis.  This is also an inflammatory disease that may cause fatal bleeding.  Symptoms of pancreatitis include severe stomach pain, vomiting, nausea, fever and rapid pulse.

Accutane Lawsuits Filed

There have been around 5,000 personal injury claims against Roche involving the link between Accutane and IBD, Crohn’s disease and UC.  In May 2007 an Alabama man was awarded $2.6 million for pain and suffering due to an induced Accutane Ulcerative Colitis.  The jury felt that Roche failed to provide adequate warning of the risks of severe and chronic IBD associated with Accutane.  This plaintiff had to go through a number of surgeries to treat the condition which is essentially incurable.  In 2008 a New Jersey woman was awarded $10.5 million again because Roche failed to warn of the risks of chronic IBD associated with Accutane therapy.  She developed an induced Accutane Ulcerative Colitis at age 14 and later had to have her colon removed.

The FDA requires that an Accutane Warning be placed on all Accutane packaging that Accutane therapy is linked to IBD, Crohn’s disease and ulcerative colitis.  Eventually, the FDA required Roche to develop a medical guide that was to accompany all Accutane packaging to make sure that consumers and healthcare providers were properly informed about Crohn’s disease and an induced Accutane Ulcerative Colitis. Then by 2009, Roche informed the FDA that they were pulling Accutane from the US market as well as 11 other countries.  Since their patent ran out they were receiving competition from generics decreasing their sales dramatically.  At that point, Roche was having to contend with generic competition and facing thousands of lawsuits necessitating an Accutane recall.





You May be entitled to Compensation, so act now.

 If you or a loved one has been injured as a result of Accutane, contact us now, to speak with our qualified professionals about possible compensation.  Call us now at 877-222-7069 or use the contact form for a free case review.  

Lawsuit Evaluation Form

Please provide us as much information as possible concerning the problems you are experiencing.

Evaluation Information

Please indicate the name of the drug or device. The more details the better.

What were the side effects?

Important Legal Disclaimer*


Our e-Newsletter

Stay up to date with the latest alerts, recalls and other useful information from RecallWarning by signing up to our free e-newsletter.

Latest FDA Alerts


Random Articles