Accutane® Psychiatric Disorders

In 1985, Accutane® packaging inserts included information that Accutane® patients have reported instances of psychiatric disorders such as depression. In August 1996, Accutane® manufacturer noted that Accutane® patients that reported depression while using the medication had no psychiatric disorders when Accutane® was discontinued. However, any psychiatric disorders were once again experienced when beginning Accutane® therapy again.

Physicians were told that simply discontinuing Accutane® use might not adequately treat psychiatric disorders and that specific psychiatric disorders therapy may need to be implemented. French studies led health authorities to require Roche have additional Accutane® side effects added, including psychiatric disorders that may lead to suicide attempt. The Accutane® manufacturer failed to notify the FDA that French officials required additional psychiatric disorders warnings be added.

The FDA issued an Accutane® warning letter to the manufacturer due to its failure to appropriately submit adverse event reports and the manufacturer claimed this was due to system delay problems that could be backed up for as much as eight years. It was not until 1998 that the FDA notified physicians that Accutane® may result in psychiatric disorders like depression, psychosis, and as the FDA stated, “rarely, suicidal ideation, suicide attempts, and suicide.”

A 1998 FDA memo included that the agency had drawn conclusions based on Accutane® evidence that the acne medication adversely affects the adult brain in serious manners, linking Accutane® to psychiatric disorders that were reportedly very severe in some instances. After drawing these conclusions, the FDA required Roche to include a bold warning to physicians that psychiatric disorders in Accutane® patients can result in “depression, psychosis and, rarely, suicidal ideation, suicide attempts, and suicide.” The new psychiatric disorders warning indicated simply stopping Accutane® medication may not be enough and further evaluation might be necessary.

Even though the FDA required Roche to add the psychiatric disorders warning the agency was still unaware of the French warnings of psychiatric disorders that were added nine months ahead of time. Following the FDA action, both Ireland and the U.K. required risk of psychiatric disorders be added to Accutane® labeling. The U.S. agency sent yet another warning to Roche regarding psychiatric disorders and the company’s attempt to minimize the seriousness of the dangers linked to Accutane®.

It is not until May 2000 that Roche finally changed Accutane® packaging labels to include the full psychiatric disorders warnings. Although the FDA recommended research be conducted to further understand Accutane® and its association to psychiatric disorders after an Accutane® meeting in September 2000, the agency never followed up with Roche and required them to do so.

The FDA has confirmed 173 cases of suicide amongst Accutane® users since 1982. Although this number is alarming, the number most likely reflects a vast underreporting since the FDA estimates only 1% of the suicide adverse events are reported. The number of actual Accutane® suicides could potentially be as high as 20,000 due to the underreporting.

Hoffmann-La Roche has maintained over the years that Accutane® is not associated to psychiatric disorders, however the number of suicides has reached 240 worldwide. The FDA now requires that physicians receive a guide entitled Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Accutane® in light of the families alarmed with the “out of nowhere” suicides. Accutane® lawsuits are predicted to continue to increase as families of Accutane® users that ended up committing suicide decide to take legal action against Roche.

PLEASE CONTACT US TO CONFER WITH AN ACCUTANE® LAWYER TO OBTAIN MORE INFORMATION ON ACCUTANE® SIDE EFFECTS AND PSYCHIATRIC DISORDERS.