Accutane was created by Roche Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) in 1982. The drug is used to treat severe acne in people older than 12, and teenagers are its primary users. Treatment can last up to six months and may be repeated if acne returns.
Unfortunately, Accutane is linked to a series of serious side effects, including inflammatory bowel diseases like Crohn’s disease, liver damage, depression, miscarriage and birth defects if taken during pregnancy.
In fact, women of childbearing age are required to enlist in a special pregnancy prevention program before beginning Accutane treatment. Because of these injuries, more than 7,000 lawsuits have been filed against Roche Pharmaceuticals.
Roche recalled Accutane in 2009, but generic versions of Accutane, known as isotretinoin, are still available and widely prescribed.
Doctors prescribe Accutane when other acne treatments fail. Because serious cases of acne can be such a physical and social burden, patients may be willing to tolerate some of the common side effects that come with Accutane use, including dry skin, headaches and cold-like symptoms.
Serious side effects may necessitate medical attention. Those include:
- Nausea, vomiting, blurred vision
- Severe stomach pain, diarrhea, rectal bleeding, trouble swallowing
- Bone or muscle pain
- Persistent fever, chills, or sore throat
- Yellowing of skin or eyes and dark urine
- Allergic reactions
- Changes in hearing
- Vision trouble
A less-common side effect of the drug is pseudotumor cerebri – benign intercranial hypertension. This is a condition in which the brain acts as though there is a tumor when there is not. It can lead to blindness. Early signs of pseudotumor cerebri include headache, nausea, vomiting and visual disturbances.
About half of Accutane users are women of childbearing age, making birth defects associated with Accutane use a significant concern. As of 2002 — the year generic Accutane was approved — the FDA had received reports of 172 babies born with a congenital defect or anomaly after maternal use of Accutane. From 1982 to 2006, more than 2,000 isotretinoin users became pregnant, resulting in many spontaneous or elective abortions.
The pregnancy prevention programs initiated by Roche seek to educate patients about taking measures to ensure that women of child-bearing age do not become pregnant while taking Accutane and that they are aware of the risk of birth defects. However, these programs do not completely eliminate the occurrences of birth defects from Accutane.
Roche has used the SMART program and the iPLEDGE program. The SMART program required patients to sign consent forms, watch informational videos, take a pregnancy test and use two forms of birth control. The program was not deemed effective, so in 2006 iPLEDGE was developed. This program required pregnancy tests from doctor’s offices and patient registration by computer.
A study completed in 2011 on Kaiser Permanente, California health care patients revealed that iPLEDGE did not significantly decrease fetal exposure to Accutane. The rate of fetal exposure was similar with both programs — an average three exposures for every 1,000 patients. The type of fetal danger resulting from exposure to Accutane is alarming, ranging from causing miscarriages to babies born with slits where ears should be.
Since 1985, Accutane has carried a black-box warning, the FDA’s most serious warning, detailing birth defect risks. The warning states: “Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount.”
The boxed warning also lists possible birth defects that could result from taking Accutane, including:
- Skull abnormalities
- Ear abnormalities
- Facial dysmorphia
- Cleft palate
- Eye abnormalities
- Central nervous system abnormalities
- Thymus gland abnormality
- Cardiovascular abnormality
- Parathyroid hormone deficiency
- Lower IQ
Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a chronic disease that is characterized by intermittent symptoms and remission. With IBD, the intestines become inflamed and may be seriously damaged. Treatments vary based on the severity of symptoms and range from medication to bowel removal.
There are two types of inflammatory bowel disease that Accutane has been linked to: Crohn’s disease and ulcerative colitis. IBD affects the colon and small intestine.
Crohn’s and ulcerative colitis manifest themselves differently and affect different parts of the intestinal tract. They share some symptoms:
- Weight loss
- Abdominal pain
- Rectal bleeding
- Bloody diarrhea
The number of cases of IBD associated with Accutane use has continued to grow over the years. From 1997 to 2002, there were 85 cases of IBD associated with isotretinoin use, but the exact connection was not confirmed. In 1999, The American Journal of Gastroenterology published a letter to the editor asserting a possible connection between isotretinoin and IBD. Another study published in the same journal in 2005 reviewed 85 cases of IBD and found that Accutane was a possible trigger for the disease. From 2003 to 2011, the FDA adverse event database received 266 cases of IBD associated with isotretinoin use.
Crohn’s is an autoimmune disorder, meaning that the body’s immune system attacks healthy body tissues. The disease often affects the small bowel and the beginning of the colon, but can also affect any part of the gastrointestinal tract. There is no cure for Crohn’s, but people may experience asymptomatic periods between flare-ups.
People with severe cases of Crohn’s may experience pain and bleeding during bowel movements, caused tears in the lining of the anus. Other complications include abscesses, inflammation of joints, thickening of the intestinal wall, and possible surgery to remove the entire colon.
Ulcerative Colitis (UC) often starts in the rectal area and progresses to the colon. The lining of the colon can become inflamed and develop ulcers that produce pus or mucous. Around half of people with UC experience milder symptoms, such as abdominal pain, blood and pus in stools, diarrhea, fever, rectal pain and weight loss.
People with severe cases of UC often require hospitalization for acute attacks. Repeated attacks cause thickening of the intestinal wall and rectum from scar tissue, which can cause infections. Complications from UC include blood clots, colorectal cancer, massive pleading, tears in the colon, liver disease, mouth sores and ulcers. The only cure is a removal of the colon.
Some Accutane users have suffered from irreversible liver damage, which can lead to cirrhosis and require a liver transplant — a serious surgery that can be life-threatening. Due to this danger, liver enzyme tests are required prior to beginning Accutane and four weeks after treatment begins. Patients with a history of liver disease should not take this medication. Additionally, alcohol should be avoided during treatment to decrease the risk of liver damage.
In addition to patient reports of liver damage, studies have documented a connection between Accutane and liver damage. In Roche’s clinical trials, 15 percent of patients treated with Accutane experienced inflammation of or damage to liver cells. In 2006, a research team at the University of California found that 11 percent of 13,772 Accutane patients tested had elevated liver enzymes. When enzymes are elevated, it can indicate that triglycerides and fats have accumulated in the liver, inflammation or that liver cells have died.
Symptoms of liver damage include:
- Upper abdominal discomfort
- Fluid buildup in the abdomen
- Swelling of the liver
- Jaundice (yellow color in the skin)
Depression and Suicide
Many people have reported depression and suicidal behavior associated with Accutane. From 1982 to 2005, there were reports of 190 suicides by Accutane users. The FDA received so many reports that in 2003 Accutane was one of the top 10 drugs most often associated with depression and suicide attempts, according to the FDA’s database of adverse events. While some people who have acne already suffer from depression, there are many reports of depression from patients with no psychiatric history.
Close surveillance of patients by physicians and friends and family can prevent depression symptoms from worsening and keep patients from harming themselves.
Symptoms of depression to be aware of include:
- Crying spells
- Loss of interest in activities
- Changes in appetite
- Difficulty concentrating
- Difficulty sleeping
- Poor performance at work or school
- Withdrawal from friends or family
- Feelings of worthlessness
- Acting on dangerous thoughts
- Thoughts about hurting or killing oneself