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BETHESDA, Md. -- The U.S. Food and Drug Administration should warn doctors and parents that children and teens on antidepressants may develop suicidal tendencies, no matter the drug or use, an expert panel overwhelmingly recommended Tuesday. The panel requested by a 2-1 margin that the FDA place "black box warnings" on labels for antidepressants, meaning that if the agency adopts their recommendation drug companies would no longer be able to run print or television advertisements for these drugs. The recommendation is one step below a ban.
"It will make prescribing more difficult," said Dr. Wayne Goodman, a psychiatrist from the University of Florida who chaired the panel. "It will create alarm among parents and children. But I think it's worth that."
Antidepressant use by children is the key issue in a Chester County double murder case that has drawn national and international attention.
The recommendation came a day after three reviews showed previously unpublished data from pediatric trials for nine antidepressants demonstrated an across- the-board potential for the drugs to cause certain patients to become suicidal. One review showed that two to three children out of a hundred given antidepressants could think about or attempt suicide.
The FDA took no action Tuesday, but said it will use the recommendation to determine what to do next. Agency officials, in comments to the panel, seemed to be encouraging a black box warning recommendation.
"A black box warning is basically for something you want everyone to know," said Dr. Robert Temple, director of the FDA's office of drug evaluation. "It's prominent. It's the first thing you see when you look at labeling."
Panel focuses in on SSRIs
Though the data about suicide mostly involved antidepressants classified as selective serotonin reuptake inhibitors, or SSRIs, the expert panel thought the warning should be expanded to all antidepressants in fear that doctors may mistakenly think certain drugs are more favorable than others.
The panel also recommended the warning include information about effectiveness. Prozac is the only SSRI approved by the FDA to treat depression in children. All other SSRIs, including Paxil and Zoloft, have not proven to be effective in treating that condition in clinical trials. All antidepressants, however, have been widely used with children through a legal practice known as "off-label prescribing."
Some on the panel also questioned the role antidepressants could play in aggression and violence. The FDA review did not address those issues.
An expert working with defense lawyers in an area murder trial claims the same mechanism that may lead some people to think about or attempt suicide may lead others to act violently toward others.
"Everyone agrees that suicide and homicide come from the same impulse," Dr. Peter Breggin, a psychopharmacology expert who will be a key medical witness in the Chester County double murder case of Christopher Pittman, said at a press conference sponsored by the Alliance for Human Research Protection during a break in the FDA hearing. "They are part of the same phenomenon."
Dr. David Healy, a psychiatrist at the University of North Wales in the United Kingdom, said Paxil studies reviewed by the British equivalent of the FDA indicate that the drug may cause some people to become hostile at a rate of six to more than 100 times than that of patients taking a placebo.
"And hostility includes homicide," Healy said.
But drug company representatives testified Monday that the industry's studies had limitations. The studies weren't designed to test whether they made patients suicidal and included no direct drug-to-drug comparisons.
Pittman is charged with killing his grandparents in November 2001. Police say he shot Joe Frank Pittman and Joy Roberts Pittman to death in their rural Chester County home before setting the house on fire and fleeing in a family vehicle. He was 12.
Now 15, he will be tried as an adult at a trial expected to begin within the next eight weeks. He could be sentenced to life in prison if convicted.
His defense team will argue that an adverse reaction to antidepressant medication led to his violent behavior. Pittman had been on a five-week regimen of Paxil and then Zoloft before the killings.
"The causality of violent behavior has now been established by the FDA," said Andy Vickery, one of two Pittman attorneys who attended the two-day hearings near Washington, D.C. "In order to discourage off-label use, they're going to go put a black box warning on Zoloft. Christopher Pittman got Zoloft off-label. If they had acted earlier, he never would have gotten the drug."
Joe Pittman, the boy's father, agreed.
"I can assure you," he said during a press conference at the hearings, "had they had warnings on these drugs, my son would not have taken them."
Although the recommendation has no direct bearing on Pittman's case, Vickery said it certainly strengthened their position. He hoped the new prosecutor, Barney Giese of Richland County, "will pay heed to what the FDA has done and agree to remand the case to Family Court."
A hearing on that issue has not been scheduled, but one is expected in the coming weeks.
The Associated Press contributed to this story.
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