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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 Crohn's Disease?
In 1932, Dr. Burrill B. Crohn, Dr. Leon Ginzburg, and
Dr. Gordon D. Oppenheimer published a landmark paper describing the
clinical features of what is known today as Crohn's disease. Crohn's
and a related disease, ulcerative colitis, are the main divisions of
the group of illnesses called inflammatory bowel disease (IBD).
Because the symptoms of these two illnesses are so
similar, approximately 10 percent of cases are unable to be diagnosed
definitively as either ulcerative colitis or Crohn's disease. In both
illnesses, there is an abnormal immune response. White blood cells
infiltrate the intestinal lining, causing chronic inflammation. These
cells then produce noxious products that ultimately lead to tissue
injury. When this happens, the patient experiences the symptoms of
inflammatory bowel disease.
Although Crohn's disease most commonly affects the
end of the small intestine (the ileum) and the beginning of the large
intestine (the colon), it may involve any part of the gastrointestinal
(GI) tract. On the other hand, ulcerative colitis limits its GI
involvement to the colon. In Crohn's disease, all layers of the
intestine may be involved, and there can be normal healthy bowel in
between patches of diseased bowel. In contrast ulcerative colitis
affects only the superficial layers (the mucosa) of the colon in a more
even and continuous distribution, which starts at the level of the
anus. Depending on what part of your intestine is affected by Crohn's
disease, your doctor may refer to your illness as ileitis (inflammation
of both the ileum and the colon). Crohn's colitis (inflammation of the
colon alone), etc.
What are the symptoms of Crohn's disease?
Common symptoms include loose, watery, or frequent
bowel movements. Other symptoms are crampy abdominal pain, fever,
and, at times, rectal bleeding. Loss of appetite and subsequent weight
loss also may occur. During periods of active symptoms, patients also
may experience fatigue, joint pains, and possibly, skin problems. Some
patient may develop tears in the lining of the anus (fissures), which
may cause pain and bleeding, especially during bowel movements.
Inflammation also may cause a fistula to develop. This is a tunnel
that leads from a loop of intestine to the bladder, vagina, or skin.
Fistulas occur most commonly around the anal area. If this
complication occurs, you may notice drainage of mucous, pus, or stool
from this opening. Because Crohn's is a chronic disease, patients will
experience periods when the disease flares up, followed by times of
remission. Some patients will experience symptoms that range from
mild to severe. But, in general, people with Crohn's disease lead
active and productive lives.
How is Crohn's disease diagnosed?
There is no single test that will unequivocally
diagnose Crohn's disease. To determine the diagnosis, physicians
consider a combination of information from the patient's history and
physical exam. They examine the results of laboratory tests, X-rays,
and findings on endoscopy and pathology tests, and exclude other known
causes of intestinal inflammation. X-ray tests may include barium
X-rays of the upper and lower GI tract. Endoscopy tests may include
flexible sigmoidoscopy and, sometimes, colonoscopy, which allow the
doctor to directly examine the colon with a lighted tube that is
inserted through the anus. During these tests, biopsies may be
obtained. It is important to make sure that an infection is not
causing the patient's symptoms, so examination of the stool for harmful
organisms is done routinely.
Because Crohn's disease often mimics other conditions
and symptoms may vary widely, the correct diagnosis may take some time.
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 |
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 1-800-404-9281 or email us here.
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