Accutane Recall

An Accutane Recall due to safety concerns is long overdue. Accutane (Isotretinoin) was introduced in the early 1980′s and is still sold under the generic names Roaccutane, Amnesteem, Claravis, Clarus, Sotret, Decutan, Isotane, Izotek, Oratane, Isotret and generic isotretinoin. Accutane is used to treat severe acne. Accutane was not officially recalled from the market but rather was voluntarily removed from the market in 2009 by the manufacturer Roche. In 2010 the FDA reviewed the removal of Accutane from the market by Roche and determined that it was not recalled for safety concerns but rather because the company was seeing increased competition from generics and had to pay out large sums of money due to Accutane lawsuits. In other words the drug was no longer cost effective.

Roche’s removal of Accutane from the market was a tactical maneuver. There is little doubt that if they hadn’t removed Accutane the FDA would have been forced to review the drug’s safety record and this is something neither Roche nor the FDA wanted to do. As of 2010 all six completed Accutane court cases have ruled against Roche with verdicts totaling some $56 million. To date thousands of Accutane cases have been filed against Roche. Where there’s flame there’s often fire… and in the case of Accutane this is a fire in the belly.

Accutane has been linked to several severe side effects including birth defects and psychological issues but the most troubling Accutane safety concerns involve problems is in the intestine. Accutane can cause Inflammatory Bowel Disease (IBD) in otherwise healthy patients. IBD is divided into two different types of conditions affecting the digestive track: Crohn’s disease and Ulcerative Colitis. Crohn’s disease causes inflammation and thickening of the intestinal wall in the section of the small intestine called the ileum. Crohn’s disease can lead to severe diarrhea and abdominal pain culminating in malnutrition and even death.

Ulcerative Colitis (UC) usually causes ulcers and swelling in the lower section of the large intestine known as the colon. Inflammation and destruction of the intestinal lining can result in having to have part of the colon surgically removed.

In 2006 a study published in the American Journal of Gastroenterology linked Accutane with the development of IBD. In this study Accutane was noted as a “trigger” for IBD. All cases of IBD in the study appeared to be linked to previous Accutane usage. In March 2010 another study in the same publication writes, “UC was strongly associated with previous isotretinoin (Accutane) exposure (odds ratio 95%).”

Given the number of cases, high percentage of ruling against Roche and the associative rate of Accutane exposure and Ulcerative Colitis it is not surprising that Roche pulled Accutane from the market. What is puzzling is that the FDA has still not recalled all versions of Isotretinoin and still allows generic manufacturers to file abbreviated new drug applications (ANDAs) to sell this product to unsuspecting patients despite the safety concerns. Severe acne is uncomfortable but it isn’t debilitating and life threatening.

If you’ve had previous exposure to Accutane and suffer from Inflammatory Bowel Disease you may be able to get compensation for your medical bills, pain and suffering and should absolutely seek legal advice. Unfortunately, no amount of compensation can cure Ulcerative Colitis or Crohn’s disease.

Possible symptoms of IBD include:

• Severe abdominal pain
• Joint pain
• Fever
• Weight loss and loss of appetite
• Fatigue
• Skin problems and skin ulcers
• Bleeding from the rectum
• Diarrhea

Accutane has been linked to:

• Birth defects
• Psychological problems, Suicide
• Stunted growth in teenagers
• Inflammatory Bowel Disease
• Ulcerative Colitis
• Crohn’s Disease

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