That doesn't mean the drugs shouldn't ever be used in children, nor is there actual proof yet that the suicide risk is real, advisers to the Food and Drug Administration (news - web sites) cautioned Monday as the agency opened public hearings on a controversy sparked when Britain last year declared most newer antidepressants unsuitable for use by depressed minors.
But use of drugs such as Paxil, Zoloft and Effexor by children and teenagers is skyrocketing despite lack of evidence that most antidepressants truly alleviate pediatric depression or the myriad other conditions for which they're prescribed, the advisers worried.
And until the questions are settled, parents and doctors need to know to look out for symptoms of agitation, anxiety and hostility that might signal trouble in a subset of young patients who may be unusually vulnerable to the drugs, they concluded.
"We want to put a speed bump in the road," said panel chair Dr. Matthew Rudorfer of the National Institute of Mental Health. "The concern that many of us felt today was that the way the SSRIs and other newer antidepressants are being used now is such that the warnings as they exist in the current labeling are not adequate or are not being taken seriously."
SSRIs and other antidepressants have long been used successfully by adults, but medicines can work differently in children. The FDA has approved only one, Prozac, to alleviate pediatric depression.
But the FDA recently ordered other manufacturers to submit to the government research on how their drugs affected children, studies dating to the late 1990s but most of which were never published because the medicines didn't prove themselves better than dummy pills.
Among 25 studies involving 4,000 children and teens, there were no actual suicides. But Britain noticed a slightly increased risk of suicidal behavior and attempts — in roughly 3.2 percent of treated youths compared with 1.5 percent given placebo — that sparked its stern warning.
But the FDA pointed to problems with some of those reports, such as big variations from study to study in what was deemed to be suicidal behavior.
Its own analysis so far suggests 109 patients experienced one or more possibly suicide-related behaviors, FDA medical reviewer Dr. Thomas Laughren said. But some clearly weren't.
Among 19 patients classified as cutting themselves, for instance, almost all were superficial, with little bleeding. So the FDA has hired Columbia University to help determine exactly how much true suicidal behavior occurred before it proposes next steps at a second public hearing in late summer.
Meanwhile, FDA has warned doctors to use great caution in prescribing any antidepressant other than Prozac to people under 18.
But that didn't satisfy parents who demanded warnings on the drugs' labels.
"You have an obligation today ... from preventing this tragic story from being repeated over and over again," said Mark Miller of Kansas City, Mo., whose 13-year-old son Matt hanged himself in his bedroom closet after taking his seventh Zoloft pill.
"Please, save our children," said Todd Shivak of Michigan, whose 11-year-old son Michael slashed his wrists in class, but survived, while taking Paxil.
Over and over, parents described youths becoming extremely agitated or anxious shortly after starting the pills — symptoms known medically as akathisia — and seemingly sudden impulses that turned deadly.
The FDA's scientific advisers warned that the youths most likely to commit suicide weren't allowed into the SSRI studies, so existing data likely won't settle the issue.
But the panel urged the FDA to heed parents' reports about akathisia — and to do some sort of education campaign about those symptoms, so young patients can be better monitored.
"Perhaps just looking at suicide attempts may not be all the answer," said Dr. Joan Chesney, a University of Tennessee pediatrician.
"I doubt that pediatricians or family practitioners are aware of the level of concern about this potential problem," said Dr. Norman Fost, a University of Wisconsin pediatrician and bioethicist. Until the FDA settles the issue, "you should be very alert to the risks of these drugs, be very alert to this ... syndrome."
But other families praised the drugs.
"I ask that you appreciate the enormous benefit these medicines have had," said Sherri Walton of Arizona, whose daughter Jordan, 14, has used SSRIs in a yearslong battle with obsessive-compulsive disorder and depression. "Her medicines were sometimes the only things she could depend on to help her."
