The Food and Drug Administration is advising doctors to be cautious when prescribing antidepressants for children after the agency began analyzing drug company reports suggesting that there may be a possible link between the drugs and self-harm.
“We are still unclear whether there is a signal here,” said Dr. Thomas Laughren, team leader for the FDA’s psychopharmacological drug group. “Based on the data, we just don’t know.”
The only antidepressant specifically approved for use in children is Eli Lilly’s Prozac, but doctors can prescribe approved medicines for any condition.
The agency has scheduled an advisory committee meeting for Feb. 2 to address the issue of antidepressants for children.
The FDA said it had reviewed reports about eight antidepressants: Paxil; Prozac; citalopram, sold by Forest Laboratories under the brand name Celexa; fluvoxamine, sold by Belgian drugmaker Solvay under the name Luvox; mirtazapine, sold by Akzo Nobel’s pharmaceutical unit Organon as Remeron; nefazodone, sold by Bristol-Myers Squibb as Serzone; sertraline, sold by Pfizer under the name Zoloft; and venlafaxine, sold by Wyeth under the name Effexor.
In June, Britain banned the use of Paxil, sold as Seroxat there, to treat children under the age of 18 because authorities there concluded that there is an increase in the rate of self-harm and potentially suicidal behavior in this age group.
Experts at the FDA say that they are uncertain whether all of the reported cases of suicidal behavior represent a real threat. One child, for example, slapped herself in the face, Laughren said. Others cut themselves. “Many of these types of behavior may not qualify as instances of suicidality,” he said. The FDA is having experts re-analyze the data.