Depression & Suicidal Tendencies

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?

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 re challenges 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 re challenge is a significant indicator of a causal link between a drug and the adverse event. The process of "challenge, de challenge, re challenge" 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 re challenge.

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.

If you have taken Accutane and experienced serious Accutane side effects call our Accutane lawyers today to find out about an Accutane lawsuit. With offices in Washington D.C. and throughout Florida we are ready to help Accutane side effects victims nationwide. Let our Accutane Attorneys evaluate your case for free today. Click here to fill out our online case evaluation form or call us toll free at: 1-800-856-6405 for your free, confidential case evaluation.