It isn't clear yet that the drugs lead to suicide, but until that is settled, parents and doctors need to know they may cause agitation, anxiety and hostility in a subset of young patients who may be unusually prone to rare side effects, advisers to the Food and Drug Administration (news - web sites) 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 warnings as they exist in the current labeling are not adequate or are not being taken seriously."
British health authorities sounded the alarm last year, saying long-suppressed research suggests certain antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. Because only one drug, Prozac, has been proven to alleviate pediatric depression, Britain declared others — drugs called SSRIs and their close relatives — unsuitable for depressed youth.
Now, the FDA is wrestling with whether the suicide risk is real, and if so, what to do here. It's difficult, because depression itself can cause suicide.
Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. But 109 patients experienced one or more possibly suicide-related behaviors or attempts, FDA medical reviewer Dr. Thomas Laughren revealed Monday.
The problem, he said, is that studies varied dramatically in what was considered suicidal behavior. Among 19 patients classified as cutting themselves, for instance, almost all were superficial, with little bleeding. So 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.
That's not enough, said anguished parents who want warnings of the possible suicide risk 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.
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.
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 FDA to heed parents' reports about akathisia — and to run 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 FDA settles the issue, "you should be very alert to the risks of these drugs, be very alert to this ... syndrome."
Some families also blamed murder and school violence on the drugs.
"These drugs are hell, look what they've done to my son," say Jay Baadsgaard after his son Corey described taking Effexor and then waking up in jail, claiming no memory of holding his Mattawa, Wash., class hostage at gunpoint four years ago.
But a few parents, despite boos from the crowd, credited the drugs with saving their children.
"I ask that you appreciate the enormous benefit these medicines have had," said Sherri Walton of Arizona, whose 14-year-old daughter Jordan has used SSRIs in a years-long battle with obsessive-compulsive disorder and depression. "Her medicines were sometimes the only things she could depend on to help her."
"I shudder to think of their plight if these medicines were not available," added Suzanne Vogel-Scibilia of the patient group National Alliance for the Mentally Ill, who say the drugs dramatically improved depression in two of her teen sons, including one who had attempted suicide.
FDA officials fear warnings before the issue is settled could dissuade patients from potentially helpful treatment. "To err in either direction has significant consequences," said Laughren.
Depression occurs in up to 10 percent of youth, and 1,883 10- to 19-year-olds killed themselves in 2001. Some 1.8 million teenagers attempted suicide that year, a quarter of them requiring medical attention, said Dr. David Schaffer of Columbia University.
In 2002, almost 11 million prescriptions were dispensed to patients under 18 for SSRIs and other newer antidepressants, to treat depression and a host of other conditions, FDA said.
