Doctors Alerted On Antidepressants, Children
Possible risk for suicides needs study, FDA saysOct 28, 2003 | The Baltimore Sun
The U.S. Food and Drug Administration alerted doctors yesterday to a possible increased suicide risk among children and teen-agers taking several of the eight most common antidepressants. But the agency said more study is needed to determine whether the drugs are at fault.
While the public health advisory is intended to remind doctors to prescribe antidepressants with caution, the language amounted to a softening of the FDA's June recommendation that doctors avoid giving young patients one of the drugs.
"I think probably that we have backed off a little bit from the advisory issued in June, which recommended against using Paxil," said Dr. Thomas Laughren, a psychiatrist and an FDA official. "I believe our position now is that we just don't know."
The advisory follows a preliminary review of results from 20 clinical trials involving more than 4,100 pediatric patients. The review showed that patients taking several of the drugs appeared more likely to think about suicide or attempt it than those taking a placebo.
But the FDA said it's unclear whether results could be explained by study bias or other factors and cautioned parents not to discontinue a child's antidepressants without first consulting with a physician. That advice was echoed by experts.
"There are people who will get alarmed by this, but I'm telling people to slow down: This is a process," said Dr. John Walkup, a child and adolescent psychologist at the Johns Hopkins Children's Center.
Still, the agency's advisory is significant in that it encompasses virtually all the most popularly prescribed drugs for depression, said Laughren. They are sold under the brand names Celexa, Prozac, Luvox, Remeron, Serzone, Paxil, Zoloft and Effexor. The alternatives involve mostly older drugs "with a lot of toxicity that also are not proven beneficial," he said.
Only Prozac has been found by the FDA to be effective in children with major depression. Until recently, pharmaceutical companies hesitated to conduct clinical trials in children for ethical reasons, and because there was no financial incentive. Doctors are free to prescribe any drug for children that is approved for adults.
But the FDA, recognizing that drugs might act differently in children than adults, has been pushing for more testing in children, in part by promising companies extended patents for testing certain drugs in pediatric patients. The result has been trials like the 20 from which the FDA is reviewing safety data.
In June, British health authorities reported that paroxetine, sold as Paxil in the United States and Seroxat in the United Kingdom, should not be used in those younger than age 18 for depression because of an increase in the rate of potentially suicidal behavior.
The FDA is still trying to determine whether that is true for Paxil or any of the other seven drugs named yesterday. The agency has completed a summary review of clinical trial safety data for the eight, but the information isn't in-depth enough to draw firm conclusions, Laughren said.
The FDA will ask companies for more comprehensive information from trials. The agency also will ask an advisory panel Feb. 2 to recommend whether the drugs should be prescribed to teens and children.
"We're looking at all of these drugs to determine whether