Oct. 28, 2003 -- The FDA is warning doctors that children and teens that take antidepressant drugs to treat major depression may face a higher suicide risk.

Although no completed suicides have been linked to the use of antidepressants in depressed children, the agency says it cannot rule out a possible increased risk of suicidal thoughts or actions associated with Paxil and other antidepressants.

The FDA says major depressive disorder is a serious condition for which there are few proven treatment options, and health-care providers must often make choices about using antidepressant drugs designed for adults, which have not yet been approved for use in children and teens.

Prozac is the only antidepressant drug currently approved for treating major depression in children.

The Evidence

In a public health advisory sent to health-care providers on Oct. 27, the FDA said it had completed a preliminary review of 20 recent clinical trials of the following eight antidepressants in more than 4,100 children:

• Celexa
• Prozac
• Luvox (not approved for use in the U.S.)
• Remeron
• Serzone
• Paxil
• Zoloft
• Effexor

The FDA says although the studies do not clearly establish a link between the use of these drugs and a higher risk of suicidal thoughts or actions, they do not rule it out.

The public health advisory letter is the latest in a series of actions by the FDA and drug manufacturers to draw attention to the possible risks of using adult antidepressants in children. The labeling of antidepressant drugs already includes a warning that the possibility of a suicide attempt is inherent in people with major depression.

In June, the FDA recommended that the antidepressant Paxil should not be used to treat childhood depression after British researchers noted a higher rate of suicidal thinking and suicide attempts among youths taking it.

In August, Wyeth Pharmaceuticals sent a letter to health-care providers warning that studies have shown that children and teens taking its drug Effexor XR to treat childhood depression are more likely to report feelings of hostility and suicidal behavior than those taking a placebo. Wyeth is a WebMD sponsor.

The FDA says more information is needed about the risks and benefits of these drugs in children, and it has scheduled a public meeting on Feb. 2, 2004, to discuss the issue.

What to Do

The FDA recommends that parents or caretakers of children and teens taking any of these antidepressants talk to their doctors before stopping the use of these drugs.

Officials say that it's also important that use of some these drugs not be abruptly discontinued.

SOURCES: News release, FDA. WebMD Medical News: "Warning Issued For Kids Taking Effexor."

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