Roche Pharmaceuticals is facing more than 7,700 Accutane lawsuits for Inflammatory Bowel Disease (IBD), ulcerative colitis, Crohn’s disease, depression, suicide, and birth defects. Plaintiffs allege that the drug-maker knew about these risks, but failed to sufficiently warn doctors and patients.
$53 Million in Accutane Lawsuit Settlements
Roche has paid more than $53 million in Accutane lawsuit settlements. In 2008, a jury awarded a woman $10.5 million in compensation and $78,500 in medical expenses for ulcerative colitis injuries. In February 2010, a man who was diagnosed with inflammatory bowel disease after taking Accutane was awarded $25 million. In June 2012, a jury in New Jersey ordered Roche to pay $18 million to resolve two Accutane lawsuits involving ulcerative colitis.
What is Accutane?
Accutane (isotretinoin) is an oral medication that was originally developed by Hoffman-La Roche Pharmaceuticals as a chemotherapy drug. Now, it is mostly used to treat cystic acne when other treatments have failed. It is a form of Vitamin A that is used for 3-6 months, and it works by reducing the amount of oil released by glands in the skin.
Since Accutane was introduced in 1982, it has been used by more than 16 million people. Accutane was discontinued in June 2009, but a number of generic versions remain on the market, including Claravis, Sotret, Amnesteem, and isotretinoin.
In June 2009, Roche withdrew Accutane from the U.S. market, citing poor sales due to competition from generics after patent protection expired in 2002. Although many people refer to the withdrawal as a recall, the FDA determined in August 2010 that Roche did not recall Accutane for safety reasons.
Studies Link Accutane and Ulcerative Colitis, Inflammatory Bowel Disease
In 2010, the American Journal of Gastroenterology published a study linking Accutane to a 4-fold increased risk of ulcerative colitis. Furthermore, evidence supports a causal relationship between Accutane and ulcerative colitis because higher doses and longer treatment (at least 2 months) was associated with the highest risk.
What is Ulcerative Colitis?
Ulcerative colitis is a type of Inflammatory Bowel Disease (IBD) that can have a devastating impact on a person’s health. The disease affects the large intestine (colon) and causes open sores, also known as “ulcers,” to develop spontaneously. The condition is very painful and causes recurrent bouts of bloody diarrhea, abdominal pain, and weight loss. Treatment typically involves harsh anti-inflammatory drugs. In severe cases, surgery may be necessary to cut out diseased parts of the intestine.
Accutane Side Effects
- Ulcerative colitis
- Inflammatory bowel disease
- Crohn’s disease
- Birth defects
- Sun sensitivity
- Joint and muscle pain
- Vision problems
- Hearing problems
- Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome
- Liver toxicity
- Elevated cholesterol
- And more