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Parents are a nervous lot to begin with.
And when a child struggles with depression, their concerns and worries multiply exponentially as they try to get their child some help.
But judging by some of the testimony and revelations before a Food and Drug Administration advisory committee this week, the treatments themselves are cause for alarm.
Studies presented to the committee found that teenagers and children who take anti-depressants are twice as likely to become suicidal as those who are given placebos. The overall risk of suicide is characterized as "low" - two to three young people out of 100 patients are likely to have more suicidal thoughts compared to those given placebos.
Yet those numbers are flat out worrisome given the fact that the pediatric use of anti-depressants is soaring in the United States. According to the FDA, doctors wrote 11 million prescriptions for anti-depressants like Zoloft, Prozac, Celexa, Luvox, Effexor and Paxil for teens and children in 2002 - and that accounts for almost eight percent of all anti-depressant prescriptions.
And last spring when questions over links between the use of anti-depressants and teen suicides were raised and the FDA ordered drug manufacturers to state on prescription sheets that they may be linked to suicide - prescriptions still rose by eight percent.
Worst of all there is no good evidence that the use of anti-depressants for children or teens is even effective. Only one drug, Prozac, is FDA approved to treat pediatric depression and it has not been linked to increased suicidal tendencies. Most other drugs commonly prescribed have failed to short their effectiveness and even Prozac didn't show much.
That prompted one member of the advisory panel, Dr. Thomas Newman, a professor of pediatrics at the University of California, San Francisco, to offer this summation: "We have very good evidence of harm and very little evidence of efficacy."
Yet despite the concerns raised, the FDA committee stopped short of recommending a ban on pediatric anti-depressants and, instead, urged a "black box" warning on physician prescription sheets. The panel also recommended requiring manufacturers to add a patient guide to the drugs' packaging that describes the risks of suicide in plain language.
We could recommend some language: "Stop. This drug might cause your child to kill himself/herself." That would be plain enough.
The bottom line in the FDA panel's recommendations is akin to changing the Hippocratic oath - "First do no harm" - with one that says, "Give it a shot, but warn them first."
That's not really a standard we're comfortable with.
What's more, this lukewarm FDA action comes against a background of other shortcomings in dealing with the nation's pharmaceutical industry and its failure to require public reporting of all clinical trials of drugs. Indeed, the FDA even refused to let one company warn that its drug was linked to suicidal behavior in children and told them to soften their wording.
Small wonder then, that the head of a house committee that oversees the FDA fumed recently that the acronym "actually stands for `foot-dragging and alibis.'"
The drug industry has belatedly offered up suggestions of a voluntary registry to make the results of drug trials available. That's not good enough.
Congress should step in and require mandatory public reporting for all drugs tested - the good and the bad results - for doctors and all the rest of us to judge.
In the meantime, parents who still opt to use drugs to treat young Johnny for depression should keep a sharp eye on him, especially during the first few days of treatment. The "cure" may kill him.
Now that's something for a parent to worry about.
http://www.usatoday.com/news/health/2004-09-15-antidepressants_x.htm USA TODAY Editorial 9/15/2004
Kids and antidepressants: The mix raises questions A Food and Drug Administration advisory panel has recommended putting a "black box" warning on antidepressants to indicate they might raise the risk of suicidal behavior in children and teens. It raises questions for parents of the more than 1 million kids on the medications. USA TODAY's Marilyn Elias gets answers from David Fassler of the American Psychiatric Association and FDA officials. Q: Does this mean the "black box" will go on antidepressants and, if so, what will it say?
A: The FDA typically follows the advice of its scientific panels, but not always. A decision is expected this fall. A black box is the strongest warning label that can be put on a medication.
If approved, the box will warn that the drugs have been found to increase the risk of suicidal behavior in children and teens. It also may say whether the drug has been found to work in studies.
Only Prozac has been approved for use in depressed children because the drug has worked in two studies.
Other popular antidepressants are approved for adults, but they have been legally prescribed to children "off-label."
Q: How serious is the risk of suicide?
A: For every 100 kids taking antidepressants, about two to three will think about or attempt suicide because they're on the drug, according to 24 studies of more than 4,600 children on the drugs. There was not a single suicide in the studies. Some parents believe their children's suicides were triggered by antidepressants; these kids were not in studies that carefully check for participants' worsening mood.
Q: Are depressed children better off not taking the drugs?
A: Not necessarily. If an antidepressant is working well, with no bad side effects, a child may be better off on it. More than half of children with major depression try to kill themselves; about 7% do commit suicide. So the benefits of the pills may outweigh the risks for some young patients.
Q: Can children be taken off the drugs immediately if a parent desires?
A: Any parent with concerns should talk to the child's doctor. Abruptly stopping antidepressants never should be done because it can trigger bad side effects. Patients are taken off drugs gradually.
Q: What is the best way to get treatment for a child who seems depressed?
A: Physical causes first should be ruled out by a doctor. Then a thorough evaluation should be done by a children's mental health specialist. A child's school behavior and any family history of mental illness should be considered before starting treatment. Parents should get as much information as possible on any drug prescribed, and children taking antidepressants almost always need to be in therapy, too.
Q: What study results did the FDA panel consider before deciding to recommend the label changes?
A: There were pediatric studies using Celexa, Luvox, Paxil, Prozac, Zoloft, Effexor XR, Remeron, Serzone and Wellbutrin.
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