Accutane (isotretinoin) is manufactured by Roche Pharmaceuticals as a medication used to treat acne. The FDA has required the manufacturer to print warnings regarding the harmful side effects of Accutane on all packaging. Side effects mentioned by the FDA include psychiatric side effects, including suicide, depression and other serious conditions. Studies also associate Accutane with an increased risk of colon cancer, Inflammatory Bowel Disease, Crohn’s Disease, and Birth Defects.
The current FDA Warning label on all Accutane packaging reads: Inflammatory bowel disease: Accutane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Accutane treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately.
Inflammatory Bowel Disease is defined as: A chronic disorder of the gastrointestinal tract, especially Crohn’s disease or an ulcerative form of colitis, characterized by inflammation of the intestine and resulting in abdominal cramping and persistent diarrhea.
The intestines become red and swollen, which can last for a long period of time and usually comes back over & over again. The symptoms of inflammatory bowel disease mimic those of an intestinal virus and can include abdominal cramping, pain, vomiting, diarrhea, weight loss, and bleeding of the intestines or rectum.
Two of the most common types of inflammatory bowel disease are Crohn’s disease and Ulcerative Colitis. Crohn’s Disease is usually characterized by ulcers or open sores along the small intestines. Crohn’s Disease can also cause swelling, infection or drainage around the rectum. Ulcerative Colitis is usually characterized by ulcers in the lower part of the large intestine, often times beginning at the rectum.
Accutane’s manufacturer (Hoffmann-La Roche) has been required to revise their Accutane label many times. The FDA has reviewed Accutane in excess of 20 instances and required the manufacturer (Hoffman-La Roche) to revise the label numerous times. Despite these efforts, side effects of Accutane have been linked to troubling birth defects.
The most recent label states: CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by females who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. Presently, there are no accurate means of determining, after Accutane exposure, which fetus has been affected and which fetus has not been affected.
This is perhaps the most tragic and saddest of side effects linked to Accutane, as innocent babies are the victims. They are either killed by the drug, or deformed for life as a result of the drug, and they have no choice in the matter. There have been thousands of voluntary abortions as a result of women who were taking Accutane when they became pregnant. There have also been thousands of reported spontaneous abortions as a result of the mother taking Accutane during pregnancy.
If you or a loved one has taken the acne treatment drug Accutane, and suffered any harmful side effects including inflammatory bowel disease, or if you have taken Accutane while pregnant or becoming pregnant, please contact the Stampfle Law Firm, LLP today for a free case evaluation.