Accutane was a drug, now discontinued, used for the treatment of acne. It was made by Hoffmann-La Roche, often known just as Roche. The company created the drug to treat severe cases of acne, those that didn’t respond to other treatments. The U.S. Food and Drug Administration (FDA) first approved the use of Accutane in 1982, but by 2009, long after the patent on the drug ran out, the company stopped making it.
Roche claimed that poor sales and the costs of lawsuits spurred the discontinuation of Accutane. Although the drug proved successful at treating acne, over the years many troubling side effects were revealed and caused a lot of suffering. Accutane lawsuits over suicides, extreme gastrointestinal side effects, and even birth defects cost Roche millions of dollars.
What is Accutane?
The generic name for the drug is isotretinoin and it belongs to a class of medications called retinoids. Retinoid compounds promote the turnover of dead skin cells and reduce inflammation. Accutane was really only intended for people with severe acne or acne that did not respond to other treatments. One course of the drug took around five months to work, and for many people made the condition worse before it got better.
Ultimately, most people who used Accutane for acne saw positive results and relief from severe acne. It was also prescribed for other skin conditions including rosacea, folliculitis, an infection of hair follicles, sweat gland infections, and other types of less common skin conditions.
Accutane was not an easy medication to tolerate for many people. As a drug of last resort for severe acne, it often worked, but there were also a lot of potential side effects. Some of these included joint pain, bone pain, inflammation, redness, and burning in the eyes, rashes and skin infections, severely dry skin, nosebleeds, and difficulty moving. Many of the side effects diminished or went away as the body adjusted to the medication, but some were severe, long-lasting, and some had life-changing consequences.
One of these more serious possible side effects of using Accutane was suicide. This was not common, but had the potential to be life-threatening. It has not been easy to find a lot of evidence to prove Accutane directly caused patients to have suicidal thoughts, but the proof that does exist, points to the drug as the culprit. About 900 cases of psychiatric conditions and symptoms could possibly be connected to Accutane between 1983 and 2013. In several of these cases a person committed or attempted suicide. The evidence was strong enough that the FDA required labeling changes to the drug to warn of the risk of suicidal thoughts.
Another possible complication of Accutane use is birth defects in the children of women who used the drug while pregnant. The risks were known early on and the FDA required that the drug carry a warning label about birth defects, but some believe it was not enough. Evidence shows that Accutane increases the risk of having a baby prematurely and of having a miscarriage. It also increases the risk of birth defects like microcephaly, a cleft palate, water on the brain, heart defects, and others.
Accutane was also found to cause debilitating inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in some people who took it. These people experienced severe abdominal pain and discomfort, inflammation in the bowels, severe diarrhea, and complications including rectal bleeding, fistulas, and bowel obstructions. Experiencing these conditions while on Accutane was not common, but for some people caused severe symptoms and painful complications.
Initially only individual cases and anecdotal evidence connected Accutane to these debilitating conditions, but eventually research found real evidence for the connection. In a study with thousands of people, the results showed that using Accutane increased the risk of developing inflammatory bowel disease 1.68 times and the risk of having ulcerative colitis 4.36 times.
Some of the more serious, although rare, side effects of the drug have led to lawsuits against Roche that have cost the company a lot of money. One lawsuit, for example, was brought by the family of a teenage who while using Accutane flew a plane into a building. The family believed his death was a suicide and that Roche was liable because they did not adequately warn patients of the risks of sudden suicidal thoughts. They sued Roche for $70 million. Ultimately the family dropped the suit because of the emotional and financial toll it was taking on them after years of fighting the pharmaceutical giant.
Although Accutane carried a special warning about the risk of birth defects, many women felt the warning was not clear enough and have sued Roche. One problem was buying Accutane online. The FDA issued a warning in 2007 that women should not buy the drug online. Doing so bypassed screening by a doctor who could have warned women about the risks of birth defects and to avoid getting pregnant while using Accutane.
Several lawsuits against Roche because of gastrointestinal conditions were settled in favor of the plaintiffs. In 2008 a young woman won $10.5 million, plus thousands of dollars for medical expenses. She had developed ulcerative colitis at the age of 14 after taking the drug for two years. In another case, a man was awarded $25 million after developing inflammatory bowel disease which resulted in the need for five surgeries and the removal of his colon. This award was eventually reversed because Roche argued that the man filed his suit late and that a court made a mistake in applying the law to the case.
Accutane has had a troubled, though long run from 1983 to when Roche discontinued it in 2009. The lawsuits, the costs of settlements and legal bills, and the risky side effects like suicide and birth defects all culminated in Roche deciding to no longer make Accutane. It was the settlements for gastrointestinal conditions and the evidence from research that ultimately caused Roche to pull the drug. Because of all the issues and negative press, Roche claimed that sales were way down for Accutane and it wasn’t worth making it anymore. The company had also seen its patent run out in 2002, so generic versions had been available for seven years.
If you were harmed by this drug, an Accutane lawsuit may be a possibility and a way for you to recover monetary damages. The potential side effects of the drug can be debilitating and may cause serious complications and major medical expenses. If you think you may have a case, talk to a lawyer to decide what your options are.