Accutane, also known by the generic name Isotretinoin, is a medication generally prescribed to reduce or fully exterminate acne. Isotretinoin is a derivative of vitamin A (classifying it as a retinoid) which is found to decrease production of sebum, an oily and waxy substance made up of the remnants of dead cells that, at one time, produced fat. This means sebum is mostly made up of fat, dead skin cells, or bacteria, which causes acne to develop on skin surfaces. Sebum has also been found to cause oily hair and increased quantities of earwax. Reducing sebum production has been successful in the attempt to thwart acne, however, the amount required is referred to as a “toxic” dose of vitamin A and results in some severe side effects.
Manufacturer Liability
Several grievances have been filed regarding complications of health, resulting in a large number of changes made over time to the warning label on the medication. As per federal law the producer of a prescription drug is required to reflect any serious and proven risks to one’s health as a result of being prescribed to their product. Accutane’s manufacturers, Hoffman-La Roche, have now been required to list on Accutane’s warning label the risk of inflammatory bowel disease in patients who previously had no history of intestinal disorders.
IBD and Rectal Bleeding
Inflammatory bowel disease can cause abdominal pain, severe diarrhea, and rectal bleeding. Rectal bleeding (medical name: hematochezia) is a severe symptom of several potential health complications and a well documented sign of the early stages of rectal cancer, therefore the occurrence of rectal bleeding is of particular concern to most individuals.
Causes of Rectal Bleeding
Many conditions can result in rectal bleeding. The conditions most often found to be the cause include inflammatory bowel syndrome, anal fissures, hemorrhoids, colon or rectal cancer, diverticulosis, ulcerative colitis, ulcerative proctitis, Crohn’s colitis, infectious colitis, ischemic colitis, and Meckel’s diverticula. Rectal bleeding varies in severity and amount of blood loss, and some of the more serious cases result in heavy amounts of blood loss which leads to fatigue, dizziness, low blood pressure, shock, and occasionally a severe drop in blood pressure when moving from sitting to standing positions known as orthostatic hypotension. Rectal bleeding in any stage of severity has also been documented to cause severe stomach pains and painful bowel movements.
FDA Regulations and Requirements
Federal law indicates that reporting side effects from prescription medication is on a voluntary basis. The high quantity of reports indicating inflammatory bowel syndrome resulted in the warning label classification, and are seen as a clear indicator of the tie between Accutane and rectal bleeding. It has been advised through many outlets to discontinue use of Accutane at the first sign of abdominal discomfort, severe diarrhea or rectal bleeding, and it is also frequently noted that there is a serious possibility of legal recourse as a result of these symptoms. Federal way injury lawyer can give you the information you need and advocacy you deserve.