Accutane (isotretinoin) is a drug created by Hoffmann-LaRoche Inc., and was used to treat severe acne among patients. The drug was initially seen as a last resort for male and female patients after antibiotics and other acne medications failed. Mild side effects can be common among patients when Accutane is taken, but much more severe effects, such as bowel disease and birth defects, have been known to occur as well.
Accutane is a retinoic acid closely related to Vitamin A. It works by controlling the amount of oil released from the oil glands within the patient’s skin. Topical and oral treatments reduce acne bacteria, slow down skin cell production to reduce clogged pores, and demonstrate anti-inflammatory properties within the patient. It was originally developed as a chemotherapy drug before its benefits for acne were observed by researchers.
Approved by the U.S. Food and Drug Administration (FDA) in 1982, Accutane successfully cleared the skin of patients with cystic acne who had been unsuccessful with other treatments. Although the drug cleared acne, many patients suffered serious side effects never advertised by Hoffmann-LaRoche Inc. Millions of men and women were prescribed Accutane up until 2009, when the patent on the drug expired.
Harmful Side Effects
Accutane was reported by the FDA to cause minimal and severe side effects within users of the drug. After Accutane was released in the U.S. in 1982, some of these effects were reported by patients no more than a year later. Warnings were slowly added to the medication over its time on the market, but not quickly enough to alert patients of the serious effects.
Accutane received a pregnancy rating of ‘X,’ as isotretinoin is a teratogen known for interfering with fetal development. If taken during pregnancy, Accutane can cause malformations and other birth defects within infants. Taking the drug shortly before conception or during pregnancy has been known to cause ear malformations, serious facial abnormalities, and even death of the child.
It is believed that inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis can be caused by Accutane. Some patients require multiple surgeries and the removal of their colon after symptoms have developed.
Roche denies any link between the drug Accutane and suicidal depression, but in 2005 the FDA alerted the public to observe isotretinoin patients for symptoms of depression and suicidal thoughts. The FDA warned that discontinuation of isotretinoin treatment may have been insufficient and that further evaluation of the individual might be necessary.
Your Legal Options
Hoffmann-LaRoche Inc. continues to sell isotretinoin under the prescribed name Roaccutane in other countries, while thousands of lawsuits have been filed against the manufacturer in the United States.
Our attorneys are currently evaluating the legal claims of people who have taken Accutane and developed serious complications, such as birth defects, gastrointestinal disorders, or other serious side effects. If you or a loved one have developed these conditions while taking Accutane or after you stopped taking the drug, please contact us through this simple form or our toll–free number, 800-598-0314.