The acne drug Accutane causes birth defects. It is also linked to Crohn’s disease and ulcerative colitis. Other serious side effects of Accutane include depression and suicide. The drug’s maker, Roche, took Accutane off the market in 2009. But generic versions of the drug continued to be available in the U.S. in 2018.
Accutane (isotretinoin) can cause serious side effects. Serious side effects of Accutane include birth defects, inflammatory bowel diseases, depression and suicide.
Women who take Accutane during pregnancy may suffer miscarriage. Women of childbearing age who planned to use Accutane had to enroll in a special pregnancy prevention program due to the drug’s risks.
The dangerous risks of the drug led to more than 7,000 Accutane lawsuits.
Roche stopped making Accutane in 2009. But U.S. patients could still buy generic versions of the drug in 2018. Roche continues to sell isotretinoin under the brand-name Roaccutane in other countries.
Birth defects from Accutane can range from miscarriages to babies born with slits where ears should be.
Since 1985, Accutane’s label has contained a black box warning detailing its “extremely high risk” of “severe birth defects.” The label warns female patients who are or may become pregnant to avoid taking Accutane.
The boxed warning also lists possible birth defects that can happen with Accutane. These birth defects include anything from ear, eye and other face-related abnormalities to abnormal skull development.
Birth defects from Accutane can also affect the central nervous system, thymus gland, parathyroid hormone and heart.
About half of Accutane users are women of childbearing age. This makes birth defects associated with Accutane-use a significant concern.
From 1982 to 2006, more than 2,000 isotretinoin-users became pregnant. These pregnancies resulted in many spontaneous or elective abortions.
As a result, Roche initiated pregnancy prevention programs.
The iPledge program became the program of choice for Accutane users. This program required women to take monthly pregnancy tests at a doctor’s office. Patient also had to register by computer.
The programs did not completely stop incidents of birth defects from Accutane.
Results of one study on the effectiveness of the programs showed an average of three fetal exposures for every 1,000 patients.
Studies link Accutane to two types of gastrointestinal disorders: Crohn’s disease and ulcerative colitis (UC).
Both Crohn’s and UC are inflammatory bowel diseases (IBD), but the conditions affect patients in different ways.
Crohn’s can occur anywhere in the digestive tract but most often affects the lower end of the small intestine. UC more commonly affects the lining of the large intestine (colon) and the rectum.
Symptoms common with both conditions include abdominal pain and cramping, weight loss, diarrhea, fever, fatigue, mouth sores, joint pain and swelling, and blood in the stool.
Crohn’s cannot be cured. UC can only be cured with surgery to remove the large intestine.
A study released in 2009 found Accutane users had almost double the chance of developing a serious bowel disorder than those who never took Accutane.
Researchers at the University of North Carolina Chapel Hill presented evidence confirming that a link exists between isotretinoin and IBD.
They compared 8,189 cases of IBD with 21, 832 healthy individuals. The results of the study showed people taking isotretinoin had a 1.68 times higher risk of developing IBD than people who did not use the drug.
This number increased to 2.67 times the risk among patients who filled four or more prescriptions of Accutane.
Patients who use isotretinoin are 4.36 times more likely to develop ulcerative colitis than patients who don’t take the drug.
Studies published in 2013 refute a link between isotretinoin and IBD, according to the American Academy of Dermatology . The findings instead propose a link between severe acne and a predisposition to IBD. Both conditions involve inflammation.
The studies also conclude that the occurrence of IBD in patients taking Accutane may be coincidental based on the person’s age. IBD usually begins around age 19. This is around the same age that a patient might suffer from severe acne and start taking Accutane.
Still, Accutane’s most recent drug label included an IBD warning.
Studies also linked Accutane to psychiatric disorders.
From 1982 to May 2000, the FDA received hundreds of reports linking isotretinoin use to depression.
These reports included 37 suicides, 110 hospitalizations for depression or suicidal behavior, and 284 cases of non-hospitalized depression.
Roche responded to the reports of depression and suicide in 1998, by adding a warning to the medication’s label. The warning stated that Accutane could cause psychiatric disorders.
Before 2005, reports of depression and suicide linked to the use of Accutane accounted for the fourth-highest number of adverse reactions occurring in the U.S.
Researchers still don’t understand how Accutane causes psychiatric events. Definitive proof of an association between depression and Accutane is still lacking.
A study published in June 2017 concluded that there may not be an association between Accutane and depression at all.
The study was a meta-analysis, or evidence-based examination, of published literature. It included all literature regarding the relationship between isotretinoin and depression from its inception up to Sept. 30, 2016. It did not review randomized controlled trials.
Results showed no apparent association between isotretinoin and an increased risk for depression. The study showed treating acne could actually reduce symptoms of depression in patients.
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