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.
Since 1982 the FDA has reported 173 cases of suicide amongst users of Accutane. Though this number may be surprisingly high, in actuality it is most likely a low estimate. The FDA estimates that only 1% of the adverse suicides are reported. Thus putting the number of Accutane related suicides as high as possibly 20,000.
As early as February 1985 Suicide and depression came to the attention of the FDA as possible side effects of the drug. There was a case of suicide reported where the patient had no history of depression. Physicians have been told that simply terminating Accutane treatment might not adequately treat psychiatric disorders and that patients may require additional psychiatric therapy.
It has been reported that some patients, during treatment with Accutane or soon after completing treatment, have experienced depression or other serious mental problems. Symptoms of these problems include:
- Irritability
- Anger
- Loss of pleasure of interest in life
- Sleeping too much or too little
- Changes in weight or appetite
- Trouble concentrating
- Suicide
- Suicidal thoughts
- Suicidal attempts
- Depression
- Aggression
- Paranoia
- Violent behaviors
- Psychosis
- Personality changes
- Mood swings
- Withdrawal
- Abnormal behaviors
Notify your physician if you or someone in your family has ever had any mental illness, including depression, suicidal behavior or psychosis. Also, notify your physician if you take medications for any of these problems.
Notify your physician immediately if you experience any of the following symptoms:
- Feelings of sadness or crying spells
- Loss of interest in activities
- Sleeping too much or insomnia
- Irritability
- Change in appetite or body weight
- Trouble concentrating
- Withdrawing from friends and family
- Loss of energy
- Feelings of worthlessness or unfounded guilt
- Suicidal thoughts