The FDA has required Hoffmann-La Roche to change their label for Accutane many times. 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.
Pursuant to FDA Rules and Regulation, the reporting of Adverse Side Effects is on
a voluntary basis. In other words, the doctor, hospital, or other medical person
or facility are not required by law to report an adverse side effect from a drug.
The FDA reported that perhaps only one in one hundred side effects ever get reported.
One could only imagine about how many serious Adverse Side Effects there are from
taking Accutane, that have never been reported to anyone!Individuals with inflammatory bowel disease have significantly higher risks of colon cancer than in the general population!
What is Ulcerative Colitis?
Ulcerative colitis is an inflammatory disease of the colon (the large intestine). It is characterized by inflammation and ulceration of the colon's inner-most lining. Symptoms typically include diarrhea (sometimes bloody) and, often, abdominal pain.
When ulcerative colitis affects only the lowest part of the colon, the rectum, it is called ulcerative proctitis. If the disease affects only the left side of the colon, it is called limited or distal colitis. If it involved the entire colon, it is termed pancolitis.
Ulcerative colitis differs from another inflammatory bowel disease (IBD), Crohn's disease. Crohn's can affect any area of the gastrointestinal (GI) tract, including the small intestine. Ulcerative colitis affects only the colon. The inflammation usually involves the entire rectum and extends up the colon in a continuous manner. There are no areas of normal intestine between the areas of diseased intestine. In contrast, such so-called "skip" areas may occur in Crohn's disease. Ulcerative colitis affects only the innermost lining of the colon, whereas Crohn's disease can affect the entire thickness of the bowel wall. Ulcerative colitis and Crohn's disease are different from irritable bowel syndrome (IBS), a disorder that affects the motility (muscle contractions) of the colon. Sometimes called "spastic colon," IBS is not characterized by intestinal inflammation. It is, therefore, a much less serious disease than ulcerative colitis. IBS bears no direct relationship to either ulcerative colitis or Crohn's disease.
What are the symptoms of Ulcerative Colitis?
The first symptom of ulcerative colitis is a progressive loosening of the stool. The stool is generally bloody and can be associated with crampy abdominal pain and severe urgency to have a bowel movement. The diarrhea may begin slowly or quite suddenly. In addition, there may be skin lesions, pains in the joints and, in children, failure to grow properly.
How is Ulcerative Colitis diagnosed?
Physicians diagnose ulcerative colitis based on patients' clinical history, as described above. The first goal of medical tests is to differentiate ulcerative colitis from infection causes of diarrhea. Accordingly, stool tests are performed to eliminate the possibility of bacterial, viral, and parasitic causes of diarrhea. Following this, the patient generally undergoes an evaluation of the colon, using one of two tests. To perform a sigmoidoscopy, the doctor passes a flexible instrument into the rectum and lower colon. This test allows the doctor to visualize the extent and degree of inflammation in these areas. A total colonoscopy is a similar exam, which visualizes the entire colon. Using these techniques, your physician can determine the category of disease to be ulcerative proctitis, limited colitis, or pancolitis. The investigation physician may take samples of the colon lining, called biopsies, and send these to a pathologist for further study. Ulcerative colitis can thus be distinguished from other diseases of the colon that cause rectal bleeding including Crohn's disease of the colon, diverticular disease, and cancer.
The Crohn's and Colitis Foundation of America, Inc., has regional and local chapters. It provides free educational materials, as well as educational activities, through local chapters in most parts of the country. The foundation may be found here.