THURSDAY, Jan. 22, 2004 (HealthDayNews) -- Zoloft and related antidepressants are both safe and effective for children and teenagers, a new report says.
The findings, from members of the American College of Neurospychopharmacology (ACNP), were announced at a news conference Wednesday in Washington, D.C., but are unlikely to quell a controversy that seems to have taken on a life of its own.
A decade ago, physicians and patients fretted over case reports indicating that some individuals, mostly adults, experienced a worsening of suicidal tendencies while taking SSRIs. SSRI stands for selective serotonin reuptake inhibitors, a class of antidepressant drugs that counts Prozac as one of its more prominent members.
Last year, the controversy flared again when British health officials advised doctors not to prescribe any SSRI antidepressants -- except for fluoxetine (the generic name for Prozac) -- for depressed youth under the age of 18 on the grounds that the drugs might increase suicidal thinking and behavior.
Last fall, the U.S. Food and Drug Administration recommended that physicians not prescribe Paxil, another SSRI, to children under 18. The agency also set up a task force to investigate the issue, with public hearings set to take place on Feb. 2.
It was against this backdrop that the ACNP established a special task force to look into the issue of SSRIs in children and teenagers. An earlier ACNP task force concluded in 1993 that there was no evidence to indicate that these drugs contributed to suicidal behavior.
The current task force reviewed 15 clinical trials, both published and unpublished, involving more than 2,000 teenagers and children. Although the trials involved different methods and outcomes, the task force concluded that SSRIs "are effective in treating depression in children and adolescents."
"We certainly looked at everything that was available and everything that's available in the medical literature," says Andrew C. Leon, a member of the task force and professor of biostatistics in psychiatry and of public health at Weill-Cornell Medical Center in New York City.
If anything, the SSRIs may have lowered the suicide rate, the researchers found. They recommend that physicians continue to prescribe SSRIs to treat depression in individuals under the age of 18.
"Everything that was reported was not about suicide; it was about suicidality, which is people talking about and feeling suicidal," says Dr. Frederick Goodwin, a member of the task force and director of the Psychopharmacology Research Center at George Washington University Medical Center in Washington, D.C. "Talking about suicide has very little to do with suicide."
In fact, some studies have shown that adults who talked about killing themselves actually had a lower incidence of suicide, Goodwin says.
"For many people, attempting suicide is a cry for help, not a determination to die," Goodwin says. "It's not that we shouldn't be concerned about people having suicidal thoughts. It means that they're distressed in some way. That issue gets confused."
So why were the British so worried about suicide and kids? "A lot of these children are depressed and suicidal to begin with," explains Dr. Eugenio Rothe, an associate professor of psychiatry at the University of Miami School of Medicine and director of the child and adolescent psychiatry clinic at Jackson Memorial Hospital. "Not everybody gets put on an antidepressant, but only those who are really depressed, so you're going to end up with a group at high risk for suicide."
The news comes as a relief to some.
"These medicines have been available for approximately two decades. They have changed the lives of literally hundreds of thousands, if not millions, of children," says Dr. Harold Koplewicz, director of the New York University Child Study Center, and author of the book More Than Moody: Recognizing and Treating Adolescent Depression. "Suicide rates among teenagers in America have decreased by 30 percent among white adolescent males, and the only change in society has been the availability of these SSRIs."
Currently, only two treatments have been shown to be effective for youth suffering from depression: SSRIs and cognitive behavioral therapy. The behavioral therapy is primarily recommended for mild to moderate depression.
"For those who have severe depression, SSRIs are the only viable treatment, so this finding reassures clinicians in general -- and, hopefully, the public -- that these are still an important part of the treatment program for teenagers who suffer from depression," Koplewicz says.
The task force concluded that tricyclics, an older class of antidepressants, are not effective for depression in this age group. "SSRIs are a leap forward over the last generation of antidepressants, tricyclics, which never were proven to be effective in teenagers and which where cardiotoxic," Koplewicz says.
According to Koplewicz, rule changes at the FDA require companies who wish to extend their patents to do additional studies showing safety in children. These studies are not conducted with the same rigor. British health officials, however, applied high scientific standards to trials, Koplewicz adds.
Another issue that may have influenced the British decision was a definitional one. A child who scratches herself and who says she wished she were dead is very different from one who says she's thinking about death all the time. "Unfortunately, suicidal thoughts are a very common event in teenagers," Koplewicz says. "They are even more common in teenagers who have depression, but suicidal thoughts are not the same as suicidal gestures or suicidal acts."
The ACNP task force findings are being considered preliminary because the panel did not have access to certain unpublished data. The final report will be released in the spring or early summer of this year.
Nine of the 10 panel members did have ties to large pharmaceutical companies, but, according to the ACNP, the task force received no financial support from that industry.
More information
The American Academy of Child and Adolescent Psychiatry and the National Institute of Mental Health have information on depression in young people.
