Accutane Side Effects - Accutane Inflammatory Bowel Disease

Roche stops market Accutane over IBD link

-The Examiner

11/11/2009 - Accutane a sobriquet of the formal isotretinoin, a type of vitamin A, that has been manufactured since 1982.

During its registered patent that ended in 2002, was linked to serious birth defects. Women who took it had to sign a consent form, prescribed two forms of oral contraceptives, submit to monthly pregnancy tests, and register with the government.

Assuredly, it was labeled with warnings to that effect. Among them dehydration, dry skin, joint and muscle pain, elevated cholesterol and liver toxicity, and possible depression that may have lead to Rep. Bart Stupak (D-Mich.) teenage son to commit suicide after taking Accutane.

Although, like others there is no proof of association between suicidal behavior and the powerful acne medication, but to the parents victims the FDA has been pressed to take it off the shelves. The exacting iPledge program demands that all doctors, pharmacists and patients join a risk-management registry to ensure that females do not become pregnant while taking Accutane was put into effect in 2005 by the Food and Drug Administration.

The evidence noted in last weeks annual meeting of the American College of Gastroenterology in San Diego, after the Swiss-based Roche Holding manufacture of the highly effective treatment for nodular acne, which can cause acne in the skin the size of pencil erasers or larger, was striped from the pharmucuetical market in late June.

The reason being is the prescription showed a link of inflammatory bowel disease in people taking the medicaton. Many researchers from the University of North Carolina, Chapel Hill, presenting a high rate of bowel disorders overall just under 2 times the odds to develop such diseases.

People who filled four or more prescriptions had an even higher risk of 2.67 times. And the odds of having ulcerative colitis among isotretinoin users was 4.36 times more likely. The comparison of 8,189 cases of inflammatory bowel disease with 21,832 healthy individuals was conducted by Dr. Seth Crockett and his colleagues. The drug is sometimes prescribed for psoriasis, lupus, various types of cancer among others.

Though Crockett stated, only about 5 to 10 people in 100,000 are diagnosed with inflammatory bowel disease each year. The data have not yet been in a peer-reviewed journal, Crockett noted, they must be considered preliminary. The fear of developing IBD is that it may result in partial or complete removal of the rectum and colon.

Roche Holding said its decision to withdraw Accutane reflected market pressures and the cost of lawsuits. Plaintiffs have won an estimated $33 million in judgments against Roche over bowel disorders as claimed by Dermatology Times, an industry publication. Isotretinoin is usually taken daily for up to six months and a cure in about 70% of patients results.

This was Roche's best-seller with about $200 million a year in sales and over 13 million people around the globe have used Accutane.

"The absolute risk is very low," Dr. Crockett said. "So if someone has disfiguring acne... it might be a risk they are willing to take."

If you or a loved one have experienced Accutane side effects such as Accutane birth defects, Accutane Inflammatory Bowel Disease or Accutane Crohn's Disease you may be entitled to compensation. Contact the Accutane attorneys of Enn