 |  | 
Published online: 17 April 2007; | doi:10.1038/news070416-6
Should kids take antidepressants?These drugs usually do more good than harm; but more monitoring is needed.Heidi Ledford 
| Popping pills: children on antidepressants should be watched closely. Getty |
|
A
re-evaluation of clinical data suggests that although antidepressants
do promote suicidal tendencies in a small percentage of children and
adolescents — as widely reported a few years ago — the benefits of the
drugs for the treatment of depression and anxiety disorders almost
always outweigh the risks.
The new study, published this week in the Journal of the American Medical Association,
makes use of data that were not available when the US Food and Drug
Administration (FDA) evaluated the drugs for their safety in children
in 2004. The findings from that evaluation led to the placement of a
so-called 'black box' warning label on antidepressants, cautioning
consumers that the drugs could cause suicidal tendencies in individuals
under the age of 18. Black-box warnings are the strongest alerts the
agency can assign before banning a drug.
After
the FDA review, Jeffrey Bridge, an epidemiologist at Ohio State
University in Columbus, and his colleagues worried that the negative
publicity surrounding the drugs had shifted attention away from any
benefit the treatments might offer to children suffering from
depression and other anxiety disorders. "The black-box warning showed
us that there was a risk of suicidal thinking and behaviour, but it
didn't take benefit into account," says Bridge. "We wanted to balance
the discussion."
Their
new analysis concludes that study participants were much more likely to
experience some relief from their symptoms than to turn towards
thoughts of suicide. That's in line with other studies looking at the
benefits of these drugs, says Bridge. But it is useful to have an
up-to-date confirmation after the 2004 FDA report, he notes.
 I don't think the labels have accomplished what [the FDA] wanted them to.  |
Gregory Simon, Group Health Cooperative Health Care System
|
|
| | |
None
of this means that the warning label should be changed, says Bridge —
at least not until more data on long-term use is collected. But his
study emphasizes that the warning message should be taken in the right
spirit — as a call to monitor young people taking the drugs, rather
than to stop people from using them. Some experts say the evidence
shows that this isn't happening.
There
are no plans to alter the warning message on these drugs, says Thomas
Laughren, director of the Division of Psychiatry Products at the FDA's
Center for Drug Evaluation and Research, in a written statement: "At
this time, nothing indicates a need for change in the 'black box'
warning, which urges attention to patients starting treatment (still
good advice), and does not suggest avoiding the drugs."
Risk-benefit analysis
Bridge
and his colleagues analysed 27 clinical trials in which a particular
class of antidepressant — known as selective serotonin reuptake
inhibitors — was used to treat children and adolescents with major
depressive disorder, obsessive-compulsive disorder, or other anxiety
disorders.
Their
data set included several clinical trials that were performed after the
FDA's evaluation, increasing the overall number of patients studied by
around 20%.
There
were no attempted suicides among the group of more than 5,300 subjects
studied, although the analysis did reveal that children and adolescents
taking the drugs had a 1% increase in their risk of thinking suicidal
thoughts or attempting suicide1. But the
benefits were more dramatic. For example, children and adolescents with
obsessive-compulsive disorder were 20% more likely to respond
positively to the drug than the placebo.
Off label
Gregory
Simon, a psychiatrist at the Group Health cooperative healthcare system
in Seattle, Washington, points out that the black-box warnings have not
worked to convey the idea that the drugs should still be used when
appropriate, but that young people should be monitored more closely.
"From a public-health perspective I don't think the labels have
accomplished what the FDA wanted them to," says Simon.
There
is no evidence that any additional patient monitoring is taking place,
Simon says, and antidepressant prescriptions declined soon after the
warning labels were added.
Only
about 20% of patients who are prescribed antidepressants return to
their doctor for the recommended minimum of three follow-up visits in
the 12 weeks following their diagnosis, according to the National
Committee for Quality Assurance, a nonprofit organization that
evaluates health care and is based in Washington, DC. Black-box labels
have had no effect on those numbers, which have remained largely
unchanged since 1999.
"The
problem is that the healthcare system is generally well organized to
respond to the patients who show up in the office, but not the ones who
don't come back," says Simon.
References
- Bridge J. A., et al. Journal of the American Medical Association,
297
.
1683
-
1696
(2007).
|
| | |
| |
|
