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 (product information) states - Pancreatitis: Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been reported. ...
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....
Clinical hepatitis considered to be possibly or probably related to Accutane therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been observed in approximately 15% of individuals treated during clinical trials, some of which normalized with dosage reduction or continued administration of the drug. If normalization does not readily occur or if hepatitis is suspected during treatment with Accutane, the drug should be discontinued and the etiology further investigated.
Pursuant to FDA Rules and Regulation, the reporting of Adverse Side Effects to a drug 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 injury or injuries 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!
Abdominal Pain
Definition of Abdominal Pain - This symptom is pain in the abdominal area, stomach region, or belly (often referred to as stomach pain) or in the abdominal area.
Alternative Names - Stomach pain; Pain - abdomen; Belly ache; Abdominal cramps; Acute abdomen.
Considerations:
Abdominal pain is a nonspecific symptom that may be associated with a multitude of conditions. Some do not occur within the abdomen itself, but cause abdominal discomfort. Some originate within the abdomen, but are not related to the gastrointestinal tract, such as a dissection aortic aneurysm. Other pain is related directly to the gastrointestinal tract.
The severity of the pain does not always reflect the severity of the condition causing the pain. Severe abdominal pain can be associated with mild conditions, such as gas or the cramping of viral gastroenteritis, while relatively mild pain (or no pain) may be present with severe and life-threatening conditions, such as cancer of the colon, Crohn's disease, ulcerative colitis, or early appendicitis.
Abdominal pain can be caused by toxins, infection, biliary tract disease, liver disease, renal disease, bladder infections, menstruation, ovulation, female and male genitourinary disease, vascular problems, malignancy, ulcers, perforation, pancreatic disease, hernias, trauma, and metabolic diseases. The list is so extensive that it would be impossible to name all of the possible diseases in each of the above groups.
Some Causes of Abdominal Pain
- Inflammatory Bowel Disease
- Crohn's Disease
- Ulcerative Colitis
- Colitis
- Colon Cancer
- Abdominal Cancer
- Regional Ileitis
- Bowel Obstruction
- Pancreatitis
- Hemorrhagic Pancreatitis
- Pancolitis
- Sigmoiditis
- Liver Disease
- Hepatitis
- Hepatotoxicity
- Lupus
All of the above have been associated with the acne drug, Accutane.
For additional information 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 .You may also visit the Mayo Clinic and search "rectal bleeding."
FDA - Accutane Information Page