Have you or a member of your family developed a serious medical condition such as:  • Inflammatory Bowel Disease • Crohn's Disease • Ulcerative Colitis • Rectal Bleeding  • Abdominal Pain  • Kidneys • Bone & Muscle Damage • Immune System  • Liver Damage • Pancreatitis • Lupus For a free case evaluation, please call 1-800-404-9281 or contact us here. Psychiatric Side Effects Suicide Suicidal Thoughts Suicide Attempts Depression Aggression Paranoia Violent Behaviors Psychosis Changes in Personality Mood Swings Withdrawal Abnormal Behaviors Under Federal Law, the manufacturer of a drug is required to revise its label to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug. The Food & Drug Administration (FDA) has required Hoffmann-La Roche to change their label for Accutane many times over the past twenty years. In 1998 the FDA required Roche to add a WARNING for Psychiatric Adverse Side Effects. In 2002, Roche was required to add "aggressive and/or violent behaviors" to the psychiatric side effects. Roche's June 2002 Label states - WARNINGS: Psychiatric Disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. ADVERSE SIDE EFFECTS: Psychiatric: Suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression, violent behaviors, emotional instability. ...some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy. Pursuant to FDA Rules and Regulation, the reporting of Adverse Side Effects is on a voluntary basis. In other words, the doctor, hospital, or other medical person or facility are not required by law to report an adverse side effect from a drug. The FDA reported that perhaps only one in one hundred side effects ever get reported, either to the FDA or the manufacturers. One could only imagine how many serious Adverse Side Effects there are from taking Accutane, that have never been reported to anyone! Congressional Investigation Accutane and its manufacturer, Hoffmann-La Roche, Inc. are currently the subject of a Congressional investigation. The Subcommittee on Oversight and Investigations of the House of Representatives Energy and Commerce Committee reconvened its investigation into Hoffmann-La Roche and Accutane in early December 2002. One of the members of that Committee, Congressman Bart Stupak stated the following during the Congressional Hearing. "The drug manufacturer, Hoffmann-La Roche, ... has continued to put profits before people. They have done everything possible to prevent the American people from learning of the psychiatric injuries and deaths associated with Accutane. Even, today I'm sure Roche will deny any causal effect of Accutane with the abortions, deaths, and suicides caused by their product." In Rep. Burton's Opening Statement, he presented four main questions - 1. When did the issue of depression and suicide first arise regarding Accutane? 2. What actions did Roche and the FDA take to determine if there was a causal link? 3. When and how was the public notified? 4. Was that public notification adequate? The drug was licensed by the Food and Drug Administration (FDA) in 1982 as an oral prescription drug for the treatment of severe acne. However, he raised serious concerns that many individuals have been prescribed this drug for less severe forms of acne. He highlighted that a significant number of psychiatric events, mostly severe depression, have been reported through post-marketing surveillance and that the FDA has received reports of 66 suicides and 1,373 psychiatric adverse events other than suicide related to Accutane. He explained how they learned through their investigation that the first report of depression in patients taking Accutane occurred in September 1982, immediately after the drug was placed on the market by Hoffmann-La Roche. Two patients in a clinical trial with 523 patients reported depression. Roche received five adverse experience reports of depression in 1983. November 1983, Roche received its first report of attempted suicide. November 1984, Roche received its first report of suicide. In may 1986 Roche received reports of five or six positive rechallenges in patients who experienced depression during Accutane therapy. In these patients, the depression went away when they stopped taking Accutane and began again after starting Accutane therapy again. Positive rechallenge is a significant indicator of a causal link between a drug and the adverse event. The process of "challenge, dechallenge, rechallenge" is a tool that the FDA uses to determine if a drug has a causal link to a particular injury. In other words, you take the drug and a problem occurs, you stop taking the drug, the problem goes away, and you once again take the drug and the problem reoccurs. However, in the case of death or permanent diseases as a result of taking a drug one would not have an opportunity to rechallenge. Congressman Burton pointed to the fact that as early as November 1984, Roche began including information on the package insert about reports of depression. Even though French authorities required a label change to include "suicide attempt" in March 1997, Hoffmann-La Roche did not inform the FDA about the added warning in France. The FDA did not learn of the new warning until much later. Therefore, the United States label was not changed to include the psychiatric warnings until February 1998. During the Congressional Hearing, the President and Chief Executive Officer of Hoffmann-La Roche, Inc. (USA), George B. Abercrombie, testified before the Committee. After giving various statements and making representations under oath regarding studies, marketing, clinical trials, and Roche's relationship with entities in Mexico, two members of the Committee told Mr. Abercrombie they did not believe his testimony, and that he had given the testimony in front of the Committee with a "straight face." Significantly, not a single member of the Committee spoke in support of Hoffmann-La Roche. The investigation is continuing. During the Congressional Hearing on Accutane on December 11, 2002, the following was reported: There were 47 suicides on the FDA database in October 2000 - there are 173 suicides on the FDA database in December 2002. Rep. Stupak forwarded to the FDA a further 37 cases which were reported to his office. (NOTE - Since the introduction of suicide as a labeled event, suicide, suicide attempt or suicide ideation do not have to be reported to the FDA outside the USA) In the last quarter of 1999, there were 2381 ADR reports for Accutane, 313 were serious - of these 89 were psychiatric, 44 2343 self injury, 5 attempted suicide, 5 completed suicide and 5 cases of psychosis. Suicide and depression as possible side effects of the drug came to the attention of the FDA as early as February 1985 in which there was a case of suicide reported where the patient had no history of depression. For more information, please visit the following web sites: Accutane/Roaccutane Action Group Accutane Congressional Committee Hearing Page FDA - Accutane Information Page ARE YOU ENTITLED TO COMPENSATION? If you believe you have been injured or have suffered a severe side effect from the use of Accutane, it may be that you are entitled to compensation. It is important that if you contact our firm for a free case evaluation. Our lawyers will analyze your case and advise whether you are entitled to compensation. Call 1-800-404-9281 or email us here.