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FDA Issues Warning on Antidepressants
Possible Suicide, Severe Depression, Anxiety, Panic Attacks in Children and Adults


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March 22, 2004 -- The FDA is issuing a warning about the possibility of worsening depression or suicidal thoughts in people, particularly children, who take any of 10 popular antidepressants, especially at the beginning of treatment or when the doses are increased or decreased.

The FDA has sent a letter to drug manufacturers requesting labeling changes on these antidepressants -- warning of possible suicide, worsening depression, anxiety, and panic attacks in adults and children.

Antidepressants involved in this warning label request are:

  • Prozac (also sold generically as fluoxetine)
  • Zoloft
  • Paxil
  • Luvox
  • Celexa
  • Lexapro
  • Wellbutrin
  • Effexor
  • Serzone
  • Remeron

"We don't know that the drugs are responsible for these behavioral changes, but nonetheless we're telling physicians and families to be aware of this and that if the behaviors do emerge, to get treatment right away," said Russell Katz, a director with the FDA's Center for Drug Evaluation and Research, in a news teleconference today.

The proposed warning label will "include information about behavioral changes that may occur in patients who are prescribed antidepressant drugs," said Katz.

"This applies to adult and pediatric patients and involves the potential for suicidal thinking or suicidal behaviors and warns the physician and family about any behaviors that might emerge that haven't been experienced before," he added.

But the FDA stopped short of recommending people discontinue taking their antidepressants.

"We specifically decided not to tell people not to use these drugs," said Katz. "We don't think that is necessary at this point."

In addition to looking for signs of worsening depression, the following symptoms may also be a sign of a problem:

  • Anxiety
  • Agitation
  • Panic attacks
  • Insomnia
  • Irritability
  • Hostility
  • Impulsivity
  • Severe restlessness
  • Mania in both adults and children being treated with antidepressants for major depression

If these changes appear, treatment should be evaluated, the FDA says. Medications may need to be discontinued when symptoms are severe, begin abruptly, or if they signal a new disorder.

There also is concern for people who have bipolar disorder (manic depression) but don't know it. Antidepressants have the potential for provoking a manic episode in these people, the FDA says. Doctors, patients, and family members should be on the lookout for any symptoms of mania, including feeling extremely happy or very irritable, inflated self-esteem, not needing as much sleep as usual, talking, or being more active than usual.

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