Antidepressants too risky for kids?
FDA hears debate on benefit, side effects of the drugs for youth
WASHINGTON (AP) -- Parents pleaded with the Food and Drug Administration on Monday to end the use of popular adult antidepressants in children, saying the drugs can increase youths' risk of suicide and violence.
"To die in this violent, unusual fashion without making a sound ... Paxil must have put her over the edge," said Sara Bostock, describing how her daughter Cecily stabbed herself in the chest with a kitchen knife shortly after graduating from Stanford University and two weeks after starting the drug.
"You have an obligation today ... from preventing this tragic story from being repeated over and over again," said Mark Miller of Kansas City, Missouri, whose son Matt hanged himself from his bedroom closet after taking his seventh Zoloft tablet.
But facing those anguished complaints were a handful of families who say antidepressants changed their children's lives by alleviating serious depression.
"My children have had tremendous improvement with their illnesses," said Dr. Suzanne Vogel-Scibilia of the National Alliance for the Mentally Ill, who has two sons using the drugs. "I shudder to think of their plight if these medicines were not available."
The FDA opened hearings Monday on the emotionally charged controversy, months after British health authorities first sounded the alarm by saying an entire list of antidepressants were unsuitable for child use.
Here, no final answer is expected until late summer. Until then the FDA has advised doctors to use great caution if they prescribe any antidepressants to anyone under age 18.
"The wrong answer in either direction ... could have profound consequences," said Dr. Russell Katz, FDA's director of neurologic drugs, in explaining the lengthy deliberation.
Searching for answers
Katz acknowledged divisions of opinion even within the FDA, where some scientists believe there is a link between some antidepressants and youth suicide behavior and attempts.
No studies have occurred in studies encompassing 4,000 children. Preliminary data, however, suggest that suicidal behavior and attempts, while infrequent, might be at least twice as frequent among some antidepressant users. Britain put the risk at around 3.2 percent of children given the drugs, compared with 1.5 percent of those given dummy pills.
But problems with that data led FDA's leaders to conclude that they can't yet answer the question.
Depression occurs in about 10 percent of youth and can lead to suicide, especially if untreated. Some 1,883 10- to 19-year-olds killed themselves in 2001, and specialists say there are 10 to 20 attempts for every suicide.
For adults, antidepressants clearly alleviate major depression, the FDA stresses.
But medicines can work differently in children. The agency has approved only one treatment -- Prozac, the best known of a family of popular antidepressants called SSRIs -- to alleviate pediatric depression, saying its benefits outweigh side effects.
Still, it is legal for doctors to prescribe adult medicines to children even if the FDA has not formally approved pediatric use, and child antidepressant prescriptions rose dramatically in the 1990s. The FDA ordered other manufacturers to submit research on how their drugs affect children and teenagers.
Last summer, British health authorities acted on the first of those findings, declaring that no depressed child or teen should use the SSRI drug Paxil, sold in Britain under the name Seroxat.
The FDA still is analyzing the studies.
The reports of suicidal behavior are a hodgepodge difficult to sort out, Katz said. Some cases counted as unintentional drug overdoses may not have been, for example, while others termed suicidal were caused by a mental illness called self-mutilation, where children make small cuts over their bodies. Sorting out just what happened is crucial to settling the issue, Katz said.
For Monday's hearing, the FDA brought together its scientific advisers to ask if it is analyzing the research appropriately, and if families or doctors need additional advice in the meantime.
It's a debate eliciting strong emotions.
The American College of Neuropsychopharmacology, considered the field's top specialists, last month declared evidence that links SSRIs to suicide too weak to justify not using them. The group points to evidence that suicides have dropped as SSRI use increased around the world, and to autopsy studies that show most suicides hadn't taken an anti-depressant, or the right dose, just before their deaths.
On the other side, critics claim SSRIs sometimes cause agitation and urgent anxiety, called akathisia, that could make certain people suicidal. Dr. David Healy, a Welsh physician who pushed for Britain's crackdown, says even he prescribes the drugs, but that they must come with warnings so doctors can monitor children for signs of trouble.
Copyright 2004 The Associated Press
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