Accutane, also known as isotretinoin, can be helpful in treating cases of severe acne, including cystic acne and similar serious, disfiguring skin conditions. However, the drug has been reported in accusation of causing a number of serious side effects, ranging from birth defects to depression and suicide. A number of people, both patients and researchers, have also reported a link between taking Accutane and developing Crohn’s disease, ulcerative colitis, and similar gastrointestinal disorders. Although Accutane manufacturer Roche Pharmaceuticals no longer distributed the drug within the United States, a number of people continue to experience adverse health conditions in the aftermath of taking the drug.
Risks Associated with Accutane
Accutane has several known side effects. One of the most serious is the drug’s teratogenicity, or ability to cause birth defects. The risk of taking Accutane during pregnancy is so great that female patients are advised to use two methods of birth control simultaneously while they are taking the drug, plus for one month before and after the treatment period. Just one dose of Accutane during pregnancy is sufficient to cause serious birth defects.
Depression and Suicide
Mental health side effects have also been reported with Accutane, including clinical depression and suicidal ideation. Additionally, the drug appears to heighten the progression of muscular dystrophy, possibly by accelerating the rate of cell turnover in skin and muscle tissues.
A growing body of evidence also links Accutane to development of certain gastrointestinal disorders, including Crohn’s disease, ulcerative colitis, and inflammatory bowel disease. These potentially debilitating diseases involve inflammation of one or more part of the digestive system, resulting in formation of lesions in the intestinal wall.
Symptoms of Crohn’s Disease
The internal inflammation and lesions caused by Crohn’s disease and related disorders cause a host of outward symptoms. Typical symptoms include:
- Abdominal pain and cramping
- Discomfort from abdominal bloating
- Diarrhea, which can be either watery or bloody
- Visible blood in bowel movements
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- Loss of appetite and weight loss
When Crohn’s disease is severe, sufferers might also experience intestinal or anal abscesses or extremely frequent bowel movements — sometimes as many as 20 a day. Systemic symptoms can also occur, such as joint pain or arthritis, malnutrition, growth retardation in children, anemia/fatigue, fever, skin lesions or nodules, and possible eye damage. Some evidence points to an increased risk of cancer in the area of the inflammation.
Accutane Litigation and Crohn’s Disease
Drug manufacturers are required to warn users about the potentially damaging effects of their products. Federal law mandates that drug companies include such warnings on the drug label itself as soon as there is reasonable evidence of a link to any serious side effect. When manufacturers have reasonable evidence but fail to provide the required warning, they may be open to litigation from those harmed by the drug.
In March 2010, a jury in New Jersey awarded a landmark $25 million to a former Accutane user who developed inflammatory bowel disease after taking the drug. Prior to that, Roche Pharmaceuticals had already been ordered to pay out over $30 million in various other lawsuits, several of which involved Crohn’s disease, inflammatory bowel disease, and related gastrointestinal disorders.
The expense associated with Accutane lawsuits is one factor that led to Roche pulling the drug from the U.S. market in 2009. Roche continues to market Accutane outside the U.S., however, and the drug is still available within the U.S. as a generic. Since Crohn’s disease can take several years to progress from vague or intermittent symptoms to a more conspicuous stage of disease, it is likely that new cases of Accutane-related gastrointestinal disorders will continue to come to light during the coming years.