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you or a member of your family developed a serious medical
condition such as: |
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Under Federal Law, the
manufacturer of a drug is required to revise its label to include a
warning as soon as there is reasonable evidence of an association of a
serious hazard with a drug.
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.
FDA - Accutane Information Page
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If you believe you have been injured or have suffered a severe side effect from the use of Accutane, it may be that you are entitled to compensation.
It is important that if you contact our firm for a free case evaluation. Our lawyers will analyze your case and advise whether you are entitled to compensation. Call 1-800-381-7992 or email us here.
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