Accutane and Ulcerative Colitis

Accutane, prescribed to treat serious nodular acne, has been linked with the development of several gastrointestinal disorders among these being ulcerative colitis, a type of inflammatory bowel disease or IBD.

What is Ulcerative Colitis?

Ulcerative colitis involves the inflammation of the lining of the digestive tract as well as ulcers primarily located in the large intestine and the rectum. The condition usually leads to severe pain as well as diarrhea and like other IBDs, can become very disabling and even life-threatening. While some individuals experience symptoms of ulcerative colitis years after their exposure to Accutane, some develop the disease almost immediately. Fortunately, although there is not a cure, doctors have been able to uncover several treatments for the disease.

Legal Consequences

Roche Pharmaceuticals, the company which engineered and marketed Accutane, has received approximately 5,000 personal injury claims due to the gastrointestinal disorders which the drug has been known to cause. In one particular case, a woman developed ulcerative colitis and filed a claim against Roche stating that the company did not make the side effects of the drug known. She received $10.5 million from the company but eventually had to have her colon removed due to the disease and continues to battle severe, chronic diarrhea. In another instance, in 2010, a man won a suit for $25.16 million dollars against the company. He had also developed the disease and needed to undergo multiple surgeries, including the removal of his colon. It was again determined that the side effects of the drug were not cited by the company.

Types of Ulcerative Colitis

There are four different classifications of ulcerative colitis, based on where the disease is located in the body. Each subtype of the disease has many of its own symptoms which allow for specific diagnosing. Ulcerative proctotis, which is solely located in the rectum, typically has symptoms such as rectal pain and bleeding. In left-sided colitis, the inflammation of the rectum stretches up the left side into the colon with symptoms being weight loss as well as bleeding and abdominal pain. The third type of ulcerative colitis is pancolitis which affects the colon as a whole. This type usually causes blood-tinged diarrhea, fatigue, weight loss, and abdominal pain as well as night sweats. The last and most dangerous form of the disease is fulminant colitis, which, like pancolitis, affects the entire colon. Fulminant colitis causes extreme distension of the colon which can lead to rupturing thereby releasing toxins into the body. Symptoms of this are usually severe pain and diarrhea as well as occasionally dehydration and weight loss.


There are several treatment therapies for ulcerative colitis although, unfortunately, there is yet no known cure. These include anti-inflammatory drugs such as corticosteroids, immune system suppressors such as mercaptopurine, laxatives, iron supplements and in extreme cases, surgery such as proctocolectomy in which the entire colon and rectum are removed.

Dealing with Ulcerative Colitis

If you develop any signs and symptoms of ulcerative colitis or any other gastrointestinal disease after taking Accutane, make sure to contact your doctor for an exam to determine whether you have indeed developed a disease. This is critical as ulcerative colitis, if left untreated, can become life-threatening and eventually fatal. It has been known to lead to the rupturing of the colon as well as hemorrhaging. The disease can also be quite painful due to the inflammation of the tissue and the severe diarrhea that most patients experience.

If you believe that you or a family member who has taken Accutane has developed ulcerative colitis or another form of IBD, please contact PA medical malpractice lawyers as you may want to seek compensation for medical expenses as well as personal injury.

Accutane and Crohn’s Disease

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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  • Vomiting
  • 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.

Accutane and IBD

Accutane has been prescribed by doctors since the 1980s to relieve symptoms of chemotherapy and to treat severe acne. Since then, thousands of patients have reported serious, debilitating side effects due to Accutane treatment. Side effects noted by patients commonly include gastrointestinal disorders. The American Journal of Gastroenterology reported the connection in 2006, specifically noting the development of inflammatory bowel disease (IBD).

Because the side effects of Accutane may have been prevented, many patients who have experienced side effects from the treatment have legal options for compensation and damages. So far, over 5,000 personal injury suits have been filed due to the link between Accutane and the development of IBD.

The Food and Drug Administration has repeatedly forced Hoffman-La Roche, the manufacturer of Accutane to change the information included on its labels because of the association of side effects. The most recent of these changes is due to IBD. Many patients report development and symptoms of IBD even after their Accutane treatment has ended. Several early symptoms may be brought on by IBD:

  • Severe abdominal pain
  • Pain in the joints
  • Sudden weight loss
  • Loss of appetite
  • Skin conditions
  • Rectal bleeding
  • Fever

Anyone who takes Accutane and experiences any of these symptoms should immediately discontinue the use of Accutane and report the symptoms to their doctor. If a positive diagnosis is given from the doctor, it is beneficial to consult with an attorney.

What is IBD?

IBD is a group of other, more specific disorders that are characterized by inflammation of the intestines. This inflammation is long-lasting and can develop over and over again, even if it should appear to clear up. Symptoms, at first, may appear to be similar to those of the stomach flu. These symptoms include abdominal cramping, abdominal pain, vomiting, diarrhea, weight loss, intestinal bleeding, and rectal bleeding.

Two diagnosable types of IBD exist. They are ulcerative colitis and Crohn’s disease. Ulcerative colitis often causes ulcers and inflammation in the large intestine. In most cases, it begins in the rectum and works its way up the colon. Crohn’s disease usually affects the small intestine, but can occur in all portions of the digestive tract, including the mouth, stomach, and colon. Ulcers result from Crohn’s disease that may go away without treatment, but they often recur in the same or other spots over and over again.

IBD Diagnosis

After discovering initial symptoms it is necessary to visit a doctor for final diagnosis. The doctor will determine if it is IBD, and then, determine which type it is – Crohn’s disease or ulcerative colitis. This is accomplished through examination of stool and observing the intestines with a colonoscope. A colonoscope is a long, flexible tube with a camera attached to the end. X-rays may also be required.

IBD Treatment

Treatment of IBD begins with a healthy, balanced diet. Exact details of the diet depend on the exact details of the symptoms. It may include cutting down on dairy and fiber. Proper sleep is required in combination with the proper diet. Plenty of rest is called for. Stress management is also a part of most IBD treatment as stress greatly aggravates any gastrointestinal disorders.

In most cases, treatment will involve more than a single doctor. Besides your family doctor, a specialist in gastrointestinal disorders (gastroenterologist) will be required. Severe cases will also require a surgeon.

Anti-inflammatory medications are prescribed to relieve the inflammation caused by IBD. Antibiotics may also be prescribed to prevent or treat infection of the ulcers. Depending on the severity, some treatments will require a trip to the hospital or doctor’s office. More powerful medications, called immunosuppressants, may also be necessary. If these treatments do not work, surgery will be needed.

Accutane Side Effects

Although Accutane can treat chemotherapy patients and relieve severe acne, it has been shown to cause severe and debilitating side effects. Lawsuits filed on behalf of patients suffering from the side effects of doctor-prescribed Accutane treatment have yielded high awards and settlements of up to $25.16 million. Over 5,000 lawsuits have been filed over bowel problems alone. The side effects of Accutane range from severe to mild, including:

Ulcerative Colitis

Ulcerative colitis is a chronic medical condition of the gastrointestinal tract. It is a form of inflammatory bowel disease (IBD) that causes inflammation and ulcers. Severe cases of ulcerative colitis have been known to cause severe bleeding, rupture of the colon, shock, and even death. After several outbreaks of inflammation, the intestinal wall and rectum will thicken from scar tissue. This results in severe chronic diarrhea. Attacks are often very painful and physically debilitating.

Some cases of ulcerative colitis require hospitalization and surgery. Many patients must have their colon completely removed, resulting in the lifelong use of a colostomy bag for the collection of digested waste.

Accutane users have reported experiencing ulcerative colitis symptoms immediately, while for others it can take months or years. There are several early symptoms of the disease:

  • Abdominal pain
  • Audible gastrointestinal disturbances
  • Urgency to produce a bowel movement following an inability to do so
  • Rectal pain and bleeding
  • Fever
  • Diarrhea
  • Vomiting

Crohn’s Disease

Crohn’s disease is another form of IBD. It generally affects the small intestine, but can develop in any part of the digestive tract, from the mouth to the anus. Symptoms can sometimes be treated with medication, but, if that fails, surgery is required. Surgery usually includes removal of the affected part of the intestine. Crohn’s disease is incurable. Even if an affected section of intestine or bowel is removed, it can recur in another section at a later time. Crohn’s disease has several symptoms:

  • Abdominal pain and discomfort, especially in the lower right side
  • Severe Diarrhea
  • Reduced or loss of appetite
  • Bloody stool
  • Ulcers
  • Painful bowel movements
  • Fever
  • Fatigue
  • Constipation
  • Eye inflammation
  • Fistulas and draining pus
  • Rash
  • Liver inflammation
  • Arthritis
  • Stunted growth

Inflammatory Bowel Disease

IBD refers to one of the two specific types listed above: ulcerative colitis and Crohn’s disease. Over 1 million people in the U.S. suffer from IBD and most of those are from ages 15 to 30. Experiencing any of the following symptoms may be a sign of IBD:

  • Abdominal pain
  • Arthritis or joint pain
  • Fever
  • Weight loss
  • Rash
  • Bloody stools

If several of these symptoms are experienced it is necessary to go to a doctor for a complete professional diagnosis.

Liver Damage/Liver Failure

Several patients who have undergone Accutane treatment have experienced chronic liver damage or even complete liver failure. If enough damage or failure occurs, a liver transplant will be necessary. Liver transplants are extremely expensive and complications can set in unexpectedly. Some early symptoms may be a sign of liver damage:

  • Loss of appetite
  • Fatigue
  • Nausea
  • Diarrhea
  • Unexpected weight gain or weight loss

More advanced stages of liver damage have more severe symptoms:

  • Jaundice
  • Abdominal swelling
  • Personality changes
  • Confusion
  • Fluid retention
  • Coma

Other Serious Side Effects

Several other serious side effects have been reported from those who have undergone Accutane treatment:

  • Suicidal thoughts (often leading to fulfillment)
  • Severe depression
  • Birth defects in expectant mothers
  • Allergic reactions

Additional Side Effects

Accutane users have reported the following mild and medium symptoms

  • Severe acne
  • Dry skin
  • Loss of hair
  • Headache
  • Eczema
  • Brittle nails
  • Sensitivity to sunlight
  • Menstrual disturbances and disruptions
  • Muscle pain