FDA Cautions
on Antidepressants and Youth
Doctors Warned About
Potentially Higher Suicide Risk for Those Under 18 on the Drugs
By Marc Kaufman
Washington Post Staff
Writer
Tuesday, October 28, 2003; Page
A02
Concerned about studies that showed antidepressants may be
leading some adolescents and children to suicidal activity, the Food
and Drug Administration issued a public health advisory yesterday
telling doctors to be especially careful in prescribing the
drugs.
The agency, which has been overseeing studies into the
effects of eight popular antidepressants on patients under 18, said
the data does not clearly establish an association between the drugs
and suicide. But it also said that a increase in suicidal behavior
in young people taking the drugs cannot be ruled out.
Thomas Laughren, the FDA's team leader for psychiatric drug
products, said the agency has found enough reason for concern to
request additional information from the drug companies that make
antidepressants, and to schedule an expert advisory committee
hearing on the subject for February.
"We're not saying these drugs can't be used" with children
and adolescents, Laughren said. "We're saying one should proceed
with caution. . . . Once we analyze the data more fully, we'll be in
a better position to make a more formal recommendation."
Only Prozac has been approved by the FDA for use in
adolescents and children -- having shown an effectiveness that
others have yet to show -- but doctors often prescribe other
antidepressants for youngsters.
The concern over antidepressants and adolescent suicidal
behavior was sparked this summer in Britain, when health regulators
warned doctors not to prescribe the antidepressant Paxil for people
under 18 years old because data showed a heightened suicide risk.
Those patients were diagnosed with major depression.
The FDA issued its own warning for Paxil soon after and
then asked the makers of eight antidepressants to give them more
information about suicidal behavior by teens using their drugs. Last
month, Wyeth Pharmaceuticals sent out letters to doctors saying that
clinical studies on its antidepressant, Effexor XR, had found an
increased incidence of "hostility and suicide-related adverse
events, such as suicidal ideation and self-harm."
Laughren said that some of the data "signaled" a possible
association between antidepressants and increased suicidal behavior,
but that it wasn't specific enough to come to any firm conclusions.
The agency has now asked the companies for specific information on
the 4,100 patients who participated in 20 clinical studies of young
people taking antidepressants.
Detailed information on how many young people are taking
antidepressants is unavailable, but experts agree that the practice
is on the rise. Mark Olfson, an associate professor at Columbia
University's College of Physicians and Surgeons, published a study
last year that estimated that in 1996, 1 percent of children under
18 were using an antidepressant.
At the same time that the FDA and others are voicing
increased concern about the effects of antidepressants on
adolescents, Laughren, Olfson and others also note statistics
showing that the overall rate of teen suicide has declined over the
past 15 years. Studies have not been done to test whether
antidepressant use is contributing directly to the decline in teen
suicides, but the researchers say a correlation is possible.
"I think the FDA needs to be cautious about attributing
particular adverse effects to a potentially helpful medication for
the general public," said David Shaffer, chief of child and
adolescent psychiatry at Columbia University. "Adolescents are a
population where suicidal [thinking] is quite common, and we have to
be sure that the data isn't just picking up that reality."
Shaffer said that the federal studies have typically shown
that around 20 percent of American teens think about suicide, or act
out such thoughts, some time during a year.
The association between antidepressants, particularly the
selective serotonin reuptake inhibitors (SSRIs), and suicide has
been controversial since the first SSRI, Prozac, came on the market
in the late 1980s. An FDA expert advisory panel studied the issue of
antidepressants and suicide in adults in 1991 and concluded that
there was no association, although some lawsuits continue to allege
a connection. Researchers such as Shaffer say they see no reason
SSRIs should have significantly different effects on young people
than on adults.
Doctors continue to increase the number of antidepressant
prescriptions they write each year. According to IMS Health, which
collects information on drug prescribing patterns, antidepressants
make up the second-largest class of drugs prescribed in the United
States. They report that more than 136 million prescriptions for
antidepressants were filled between mid-2002 and mid-2003, an
increase of 13 percent over the previous year.
© 2003 The Washington Post
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