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Accutane Acne Medication and Severe Side Effects

Accutane acne medication is reported to have severe side effects including increased risk of inflammatory bowel disease (IBD), birth defects, depression and suicide. Recently, Health Canada warned about a risk of serious skin reactions. These Accutane side effects have resulted in lawsuits being filed against the manufacturers of the Accutane medication. Although Accutane has been pulled from the market, at the manufacturer's request, lawsuits are still pending.


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Accutane was prescribed for the treatment of severe acne or recalcitrant cystic nodular acne. It was often prescribed as the next-level treatment for acne after a course of Tetracycline had failed to diminish acne breakouts. Accutane worked by shrinking the skin's oil glands and diminishing their oil output. Accutane was a capsule taken orally every day for several months. Accutane, generically known as isotretinoin, was a synthetic derivative of vitamin A.

AccutaneAccutane was first manufactured and distributed by Hoffman-LaRoche in 1982. Before it was pulled from the market, Accutane reportedly had annual sales of more than $1.2 billion. Accutane was pulled from the market by its manufacturer, Hoffman-LaRoche, who cited market pressure as the reason for pulling the medication.

With reports of medical problems and side effects linked to Accutane, the FDA was involved in alerting the public and promoting changes to the warning label. The FDA has put limitations on prescribing and filling Accutane prescriptions to avoid abuse and unauthorized use of the potentially dangerous drug.

Although Accutane has been pulled from the market, generic versions of isotretinoin, including Amnesteem, Claravis and Sotret, are still available on the market.

Accutane Side Effects

Accutane's side effects include inflammatory bowel disease, risk of birth defects, increased risk of suicide and a risk of serious skin reactions.

Accutane and Inflammatory Bowel Disease (IBD)

FosamaxAccutane was linked to an inflammatory condition that occurs in the patient's colon and small intestine. Patients who develop inflammatory bowel disease experience chronically red and swollen intestines, weight loss, bleeding and pain and cramping. Symptoms of inflammatory bowel disease generally appear within four years of the last exposure to Accutane. Treatment of inflammatory bowel disease can involve surgery to remove part or all of the patient's colon.

Inflammatory bowel disease includes two different diseases: Crohn's disease and ulcerative colitis. Both affect the digestive system, although ulcerative colitis affects only the lining of the bowel, whereas inflammation from Crohn's disease can affect deep layers of the intestinal wall.

Patients with inflammatory bowel disease can develop serious problems including dehydration and anemia if the problem becomes severe. Problems associated with inflammatory bowel disease—such as diarrhea—can make it difficult for patients to continue on with their normal day-to-day living. Lawsuits have been filed against the maker of Accutane, alleging patients were not adequately warned about the risk of inflammatory bowel disease.

Accutane and Birth Defects

Shortly after international distribution, Accutane was in the news for allegations of causing severe birth defects when the mother took Accutane while pregnant. Birth defects included facial and bodily abnormalities and disorders of the brain, central nervous system, or cardiovascular system in the newborn baby.

In 2006, the FDA implemented the iPLEDGE program, designed to prevent the use of isotretinoin while pregnant. Patients who wanted to take Accutane were required to register for iPLEDGE, complete an informed consent form and, for women who were of childbearing age, comply with necessary pregnancy testing and be on two methods of birth control, unless the patient agreed to be abstinent.

Accutane and Suicide

AccutaneBefore being removed from the market, Accutane was linked to an increased risk of depression, psychosis, suicidal ideation, suicide attempts and suicide. According to the FDA, from the time isotretinoin was marketed in 1982 through August 2004, there were 4,992 spontaneous reports of psychiatric disturbances associated with the use of isotretinoin in the US. Between 1982 and 2002 there were 165 reported suicides. However, the FDA noted that suicides linked to isotretinoin could be underreported, meaning there could be more than the 165 reported suicides. Prior to being removed from the market, Accutane the FDA warned that patients treated with isotretinoin should be observed for symptoms of depression or for suicidal thoughts.

Accutane and Skin Reactions

In February, 2010, Health Canada and Hoffman-LaRoche issued a warning about the increased risk of serious skin reactions in patients who used Accutane. Those risks include Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Both conditions are rare but can be serious, resulting in hospitalization, disability or death.

Accutane's Manufacturer

Hoffmann-LaRoche is the U.S. subsidiary of "The Roche Group", a leading international health care company focused on pharmaceuticals, diagnostics and vitamins. The Roche Group has been in international news for fraudulent conduct, discovery abuses, and patent infringement, including fraud against the United States Trademark and Patent Office. In 1999, Roche budgeted over one billion dollars for criminal fines, penalties, and settlement of cases.

Accutane Side Effects Legal Help

If you or a loved one has had adverse side effects from using the acne medication Accutane, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please click on the link below.

Last updated on Oct-16-14


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