The acne medicine Accutane has been associated with severe side effects including birth defects in newborns and severe depression leading to possible suicide among teenagers and young adults.
Accutane, made by New Jersey-based Hoffman-La Roche Inc., hit the market in 1982. The U.S. Food and Drug Administration has since recorded thousands of pregnancies among Accutane users. The majority ended in abortion or miscarriage, but at least 160 babies were born with drug-caused birth defects.
The FDA also has received many reports of suicide linked to Accutane, including 66 cases by December 2000. It is estimated the number far exceeds 100 today, while thousands more may have experienced depression and other psychiatric problems.
Accutane, known generically as isotretinoin, has been associated with a broad range of other illnesses, including brain problems resulting in vision loss or stroke and abdominal problems ranging from liver and intestinal damage to inflammatory bowel disease, or IBD, including Crohn’s disease and ulcerative colitis. In November 2008, a jury handed down a $12.9 million verdict for three Florida patients who claimed they developed a chronic bowel disorder after using Accutane. (See story
Millions of people have used Accutane, with an estimated 100,000 Accutane prescriptions written each month, mostly for teenagers and young adults. Accutane is used to treat severe acne that is resistant to topical creams or antibiotics, with a typical course of treatment lasting 15 to 20 weeks.
In August 2005 the FDA enacted unprecedented measures seeking to ensure the medication is not used by pregnant women and revised Accutane labeling to warn against the symptoms of depression and suicidal tendencies.
The link between Accutane and possible suicide came to into broad public view in October 2000, when U.S. Rep. Bart Stupak of Michigan held a news conference about Accutane and the suicide death of his 17-year-old son, B.J. The congressman said his son, who had been a popular athlete and president-elect of the student council, had shown no signs of depression until taking Accutane. Stupak said his studies showed that about two suicides each month were related to Accutane use.
A study released September 2006 showed that Accutane caused depression in laboratory animals. The study was considered significant because the lab mice tested lacked other factors -- such as depression caused by poor self-image -- that made testing of human adolescents difficult.
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The FDA labeling revision for the drug states in part: "All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary."
Accutane presents such a high risk during pregnancy that the FDA now requires that all female users enroll in a national registry called iPLEDGE and sign a form stating they know of the drug’s risks, which include mental retardation and severe brain and heart defects in babies. Women must undergo a doctor-performed pregnancy test before being prescribed Accutane and then be re-tested each month thereafter. They also must agree to use at least two forms of birth control while taking Accutane.
Among the signs of Accutane side effects are headaches, nausea, vomiting, blurred vision, hearing problems, dizziness, mood changes, severe stomach pain, diarrhea, rectal bleeding, dryness of the eyes, yellowing of the skin or eyes and dark urine.
Kline & Specter PC, a Philadelphia-based law firm has had success litigating product liability and prescription drug lawsuits nationwide. At this time, however, we are no longer accepting Accutane cases.
U.S. Drug and Food Administration