On March 22, 2004, the Food and Drug Administration (FDA) issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.
The concern is that patients being treated with antidepressants may develop worsening depression and suicidal thinking, which can occur during the early period of treatment. Physicians are urged to be particularly vigilant in patients who may have bipolar disorder in that hypomania or mania could be triggered. The agency is also advising that all patients be observed for certain behaviors that are known to be associated with these drugs:
- Anxiety
- Agitation
- Panic Attacks
- Insomnia
- Irritability
- Hostility
- Impulsivity
- Akathisia (severe restlessness)
At this point in the ongoing research and evaluation of the current studies, it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior. However, the FDA is asking manufacturers to change the labels of the implicated drugs to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening. The drugs being reviewed are:
- Bupropion (Wellbutrin, Zyban)
- Citalopram (Celexa)
- Fluoxetine (Prozac, Serafem)
- Fluvoxamine (Luvox)
- Mirtazapine (Remeron)
- Nefazodone (Serzone)
- Paroxetine (Paxil)
- Sertraline (Zoloft)
- Escitalopram (Lexapro)
- Venlafaxine (Effexor)
The FDA expects to release additional results later in the summer.
