Accutane(Isotretinoin) is a powerful drug used in the treatment of acne. Four to five months of isotretinoin treatment usually leads to clearing of acne for one year or more after the medicine is stopped. Most other acne-controlling medicines are antibacterial agents, which are effective only if the medicine is used daily. Accutane is a retinoid related to Vitamin A. Is widely used in the treatment of severe nodular acne, primarily in adolescents.
This medication has been linked to the onset of Crohn's Disease, ischemic or ulcerative colitis, and auto immune disorders (Acquired Immunodeficiency). Individuals with inflammatory bowel disease have a significantly higher risks of colon cancer than in the general population.The most recent label states - 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.
Hoffman-LaRoche, the maker of Accutane, has also notified doctors that the drug may cause depression and/or psychosis up to and in some cases including suicide. They did this after the FDA notified doctors that they should watch their patients for these side effects in 1998.
The potential danger of Accutane became highly publicized when Republican Congressman Bart Stupak’s 17-year-old son committed suicide. Bart Stubak Jr., aka B.J., shot himself in the head in May of 2000. Stupak says his son’s suicide may be linked to his use of Accutane. Congressman Stupak was quoted saying "We are up over 100 reports, that's just what is coming in to us, so I believe there are probably over a thousand cases," Stupak said. "The average time is 88 days from when you start taking it, and the effect is very sudden.... You are doing strange things at 3 a.m. and you are dead at 7 a.m."
According to USA Today, approximately 66 cases of suicide and over 1300 cases of psychiatric problems by Accutane users have been reported to the FDA as of December 2000. In 1986, Accutane’s warning label stated some potential risk of depression linked to the drug. French officials required Hoffman-LaRoche to add the risk of suicide to its European packaging in 1997. The FDA did not require the US version to be modified until 1999.
In 2001, the FDA announced that new warning labels and consent forms would be required for Accutane users. The form urges patients to watch for signs of depression. These signs include but are not limited to: feelings of sadness, irritability, feeling unusually tired, loss of appetite, trouble concentrating, thoughts of hurting themselves or suicidal thoughts.
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Accutane

