A U.S. Food and Drug Administration (FDA) employee testified in 2002 before a committee of Congress that 3,104 adverse psychiatric events had been reported among users of Accutane®.

The administrator said the FDA was aware of 173 cases of suicide associated with the drug. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, made the report to Congress.

Accutane® was approved in 1982 to treat patients with severe nodular acne. The generic name of the drug is isotretinoin. In the years since its approval, the medication has been accused repeatedly of causing many severe, sometimes fatal side effects. As early as September 1983, the year following its approval, Accutane® was reported to have so many severe side effects that Public Citizen requested the FDA include warnings on its labels for the drug.

In 2000 the FDA reported 147 patients taking Accutane® committed suicide.

FDA to Include Warnings

In July 2005, the FDA added the following label warning about the drug for doctors and patients, "Suicidal Thoughts or Actions: In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts in association with the use of isotretinoin. . . . ."

The FDA went on to admonish doctors that every patient should be closely watched for symptoms of depression or thoughts of suicide, such as:

• Sadness
• Being irritable
• Decreased pleasure in social activities or sports
• Sleeping too much or having trouble sleeping
• Shifts in weight or appetite
• Moodiness
• Problems with concentration
• Psychosis
• Aggression
• Feelings of hopelessness, guilt, worthlessness, helplessness

Not until June of 2009, however, did Roche, the drug's manufacturer stop making Accutane® and recall it from the market.

Other incidents relating Accutane® to suicide include:

• A statistics analyst of adverse drug reactions said that there were 216 drug-linked suicides in children under 18 between 1989 and 2003, and of these, 72 could be linked to Accutane®. The report was made to the Alliance for Human Research Protection.
• Roche, in 1999, told the FDA that not one of 168 reported suicides could be tied to Accutane® directly

The FDA now warns patients "NEVER" to buy the medication illegally or in any generic form over the Internet and "NEVER" to buy the drug without first consulting a doctor.

In the August 2005 addition to its label warning about potential problems of suicidal thoughts or actions, the FDA noted that discontinuing the treatment might be "insufficient" and that patients should have further evaluation by a qualified health care professional.

Contact an Accutane® Lawyer About Your Circumstances

If you or anyone you love has had severe emotional problems or thoughts of suicide after taking Accutane®, we encourage you to seek the advice of an Accutane® recall lawyer, an attorney experienced in this area of the law. We understand the defects and potential harm associated with this drug and would like to help you seek the compensation you are entitled to. If your loved one committed suicide and had a history of taking Accutane®, we are available to speak with you in a private setting with compassion.