WEDNESDAY, Sept. 15, 2004 (HealthDayNews) -- A recommendation from expert advisors to the U.S. Food and Drug Administration that stronger warning labels be placed on antidepressants, due to potential links to child suicide, could leave many depressed children without a valuable treatment option, experts say.
"I do have concerns," said Dr. David Fassler, a professor of psychiatry at the University of Vermont. "I'm concerned that these actions may be misinterpreted and may discourage some parents from getting help for their kids. And that would really be a tragedy, because we really can help most of them."
After months of scientific analysis and an emotional public hearing in Washington, D.C., on Tuesday, two FDA advisory panels found by a 25-0 vote that there was, indeed, evidence that use of antidepressant medications might raise risks for suicide and suicidal thoughts in some pediatric users.
In another recommendation, this time by a 15-8 vote, an FDA panel advised strengthening the so-called "black box" warning label accompanying drugs like Prozac, Paxil, Celexa, Effexor, and Zoloft, cautioning physicians, patients, and patients' families of the suspected risk.
While the recommendations are not binding, the FDA usually follows the guidance of its advisory panels.
But while most child psychiatrists agree that a minority of children may be adversely affected by antidepressants, they also believe these drugs have saved children's lives.
"Overall, if you look at the data, these selective serotonin reuptake inhibitors (SSRIs) have decreased suicidology and suicide attempts" among both children and adults, said Dr. Jon A. Shaw, director of child and adolescent psychiatry at the University of Miami.
He noted that the effectiveness and safety of antidepressants vary widely, so it's tough to come up with a one-size-fits-all recommendation when it comes to their use. Paxil, in particular, has properties that may make it less safe than other SSRIs, especially if not taken as prescribed, Shaw said.
On the other hand, for many adults and children, Paxil has worked wonders, he said.
However, after the latest FDA recommendations -- which especially singled out Paxil as one of the drugs most strongly linked to child suicide -- Shaw worries that doctors will shy away from prescribing these and similar medications to children.
"I think practitioners will be so scared to death of malpractice liability concerns," he said. "To tell you the truth, I saw a girl recently with severe anxiety disorder, and I found myself staying away from Paxil, which is one of the SSRIs most efficacious against anxiety," he said.
Consultations with the girl's parent led Shaw to eventually place her on Paxil, however, "and she's had a very good response," he said.
The makers of SSRIs rushed to their defense after Tuesday's announcement. Susan Bro, a spokeswoman for Pfizer, the maker of Zoloft, told The New York Times that it was still too early to speculate on how or whether the recommendation might change the company's advertising policy. Although only Prozac has received full FDA approval for use in child depression, Zoloft is commonly prescribed for "off-label" use in those under 18, and is currently the most-prescribed antidepressant in this age group.
Forest Laboratories, the makers of Celexa, said that patient characteristics -- not the drug -- may be to blame for reports of suicidal behaviors among children taking the medication.
Shaw concurs that there's a wide spectrum of patient responses to SSRIs. And he said close monitoring is always important, especially in the first week or two of treatment, as drugs cause dramatic changes in mood.
"One theory is that when they get better, sometimes they are actually at higher risk for suicide ideology, because they now have the wherewithal to act," he explained. "Their depression lifts, and all of a sudden they are more activated."
So parents who notice a sudden increase in manic, "giddy" behavior in their child soon after he or she begins drug therapy may want to keep a watchful eye out, he said.
Still, Shaw believes that the proposed new FDA recommendations are not a sufficient reason to discontinue antidepressant therapy for children apparently helped by the treatment.
"There's a lot of anecdotal evidence that these drugs are lifesaving, and they do work," he said. "If it's not broke, don't fix it. I've had lots of parents call me up and want to stop their child's medication, then I talk to them. You have to lay it on the line for parents, so they understand what the risk really is."
Fassler agreed. "These medications have been used successfully with literally millions of children, and I expect we'll continue to use them," he said. "But they do need to be used carefully and appropriately, and patients of all ages need to be monitored closely throughout the course of treatment."
More information
Go to the FDA for more on antidepressant use.
