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When the FDA approved Accutane in 1982, it was hailed as an effective, innovative drug for treating severe and recalcitrant cystic nodular acne. However, not long after doctors started prescribing it, reports of severe birth defects emerged, and over the years, multiple warnings have touched on suicidal behavior and development of inflammatory bowel disease.
Manufactured by Roche, Accutane is only given after a patient has been prescribed a course of antibiotics to reduce breakouts. The drug, essentially a high dosage of a Vitamin A-derived retinol, shrinks the body’s oil glands to reduce output and sebum formation.
During the height of its popularity, Accutane brought Roche sales of $1.2 billion per year. Roche pulled the drug from shelves in 2009, although generic isotretinoin is still on the market as Amnesteem, Claravis, and Sotret.
Inflammatory Bowel Disease
Most pending lawsuits concerning Accutane focus on inflammatory bowel disease (IBD), a side effect that patients allege Roche never disclosed.
The condition – Crohn’s disease and ulcerative colitis – inflames the patient’s colon and small intestines. The area is chronically red and swollen, while patients experience weight loss, bleeding, pain, and cramping. Signs frequently appear four years after taking Accutane.
With these two conditions, the digestive system becomes affected. Ulcerative colitis affects just the lining of the bowels, while Crohn’s disease goes even further, to the deep tissue layers of the intestine walls. In response, patients may develop dehydration or anemia or, because of diarrhea, may find it difficult to go about their daily lives.
Patients experiencing IBD often have to change their diets or take anti-inflammatory medications, antibiotics, or an immunosuppressant. More extreme instances require surgery to remove all or part of the colon.
Although the FDA required Roche to modify its label in 2005 to warn about IBD symptoms, a study, published in the American Journal of Gastroenterology a year later, confirmed a link between taking Accutane and developing IBD. Supporting this, the same journal put out a study in 2010 that stated patients’ risks were four times greater, depending upon the dosage.
Accutane has since been classified as a Category X drug, which means doctors are prohibited from prescribing it to pregnant women. Because reports of severe birth defects started nearly right after its approval, the FDA required a black box warning in 1985.
Defects are significant and severe and can occur both to a child’s appearance and functioning:
- Facial deformities
- Bodily abnormalities
- Disorders to the brain, central nervous system, and cardiovascular system
Reports of birth defects continued years after the black box warning, so the FDA instituted the iPLEDGE system in 2006. Patients taking the drug were required to register with the iPLEDGE system, complete an informed consent form, follow all required testing, and use two forms of birth control or be abstinent.
Other Side Effects
In 1998, the FDA required the drug to have a warning about Accutane’s link to suicide and depression. Even after that point, studies showed that Accutane was responsible for 4,992 spontaneous reports of psychiatric disturbances from 1982 to 2004 and 165 reports of suicide from 1982 to 2005.
Although a clear relationship has not been confirmed, a study in the American Journal of Psychiatry found that Accutane decreases patients’ orbitofrontal cortex activity by 21 percent. This is the part of the brain responsible for decision making, cognitive processing, and an individual’s personality.
Following this, the Journal of Experimental Biology and Medicine published findings indicating Accutane decreases reuptake transmitters’ activity, which leads to a decrease in serotonin.
In addition to these findings, Canadian researchers discovered a potential link between Accutane and life-threatening skin reactions like Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
Patients affected with IBD have gradually come forward. 13 trials have already passed, with judges ruling in the plaintiffs’ favor.
Yet, by the end of 2014 and after a series of bellwether trials, the presiding judge ruled the post-2000 warning label sufficiently warns about IBD risks. The judge stated medical and patient guides specify the condition as a potential side effect.
In 2015, Accutane lawsuits are getting more attention. Plaintiffs allege that, while the paperwork warned of the risk, doctors did not discuss it. Patients considering legal action must file within the two-year statute of limitations.