Parker, Waichman, Alonso LLP

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Injured by Accutane?

Parker Waichman Alonso LLP is evaluating Accutane (isotretinoin) cases where any of the following injuries have occurred.

• Inflammatory Bowel Disease
• Premature Closure of Growth Plates
• Birth Defects
• Ulcerative Colitis
• Crohn's Disease
• Inflammatory Bowel Syndrome
• Rectal Bleeding
• Abdominal Pain
• Central Nervous System Injuries
• Bone and Muscle Loss
• Cardiovascular Injuries
• Liver and Kidney Damage
• Pancreatitis
• Immune System Disorder
• Lupus
• Hearing and Vision Damage
• Thyroid Disorders
• Suicidal Thoughts & Behavior

Suicide Link
The Food & Drug Administration (FDA) approved Accutane in May 1982. Accutane is prescribed to combat severe acne. In 1998, the FDA advised doctors who prescribed Accutane to watch their patients for signs of depression. Afterward Hoffman-LaRoche, the maker of Accutane notified doctors that the drug "may cause depression, psychosis, and on rare occasions suicidal ideation, suicide attempts and suicide."  However, the knowledge of the potential danger associated with Accutane did not become widely known until a Congressman's son committed suicide. Rep. Bart Stupak says his 17-year-old son's suicide on May 14, 2000 may be linked to the popular acne medicine. Bart Stupak Jr., known as "B.J.," shot himself in the head with his father's gun. Stupak was popular in school, a football player, and killed himself after a prom-night party. In assessing how many potential suicide cases could be linked to Accutane, Rep. Stupak stated, "We are up over 100 reports, that's just what is coming in to us, so I believe there are probably over a thousand cases," Stupak said. "The average time is 88 days from when you start taking it, and the effect is very sudden. You are doing strange things at 3 a.m. and you are dead at 7 a.m." The FDA has received reports of 66 suicides and 1,373 cases of psychiatric problems among Accutane users as of early December 2000 according to a report in USA Today. Accutane's package warning first stated potential relationship between Accutane and depression in 1986. Although French officials required that Hoff-LaRoche add the risk of suicide to the package insert of the European version of Accutane in March 1997, the FDA did not require such a change in the USA until 1999.

Birth Defects
If Accutane is taken during pregnancy or within a month of becoming pregnant, it is known to cause severe birth defects, including brain and heart defects and mental retardation. Due to the inadequacies of the SMART (System to Manage Accutane Related Teretogenicity) program initiated by Roche on April 10, 2002, and the continuation of babies born with Accutane-related birth defects, the new iPledge program began in early 2006. iPledge requires women of childbearing age to have two tests to ensure that they're not pregnant before the initial prescription, and monthly pregnancy testing before each refill. Home pregnancy tests do not suffice to fulfill this requirement. The doctor then enters the pregnancy test results into the iPledge system, and the woman is required to fill her Accutane prescription within seven days. Furthermore, women must agree to use two forms of birth control while using the drug. They also self-register on iPledge to certify that the are indeed using two forms of contraception.  These programs come too late for the hundreds of children born with birth defects caused by Accutane usage.

Legal Help for Accutane Victims
If you or a loved one took Accutane and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.