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The FDA issued a warning this month saying
that patients on certain antidepressants should be monitored closely for
warning signs of suicide. |
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The FDA issued a warning this month saying
that patients on certain antidepressants should be monitored closely for
warning signs of suicide.
The FDA has sent a letter to drug manufacturers
requesting labeling changes on these antidepressants -- warning of possible
suicide, worsening
depression,
anxiety, and
panic attacks in both adults
and children. Most antidepressant labels already contain some fine-print
statement about suicide, usually that the possibility is inherent with
depression.
Although admittedly, it is not known for
sure if these drugs do indeed increase suicidal behavior; the FDA decided
that it was best to implement the labeling requirements immediately until
it had a chance to examine the research available on the issue.
The 10 drugs of concern are newer generation
antidepressants:
Most of these drugs belong to a class of
antidepressants known as
SSRIs or SSRI-like drugs which act through the
brain chemical serotonin; while Remeron,
Serzone and Wellbutrin, operate
differently.
The issue started when dozens of anguished
parents pleaded with FDA in a meeting last month to add such warnings, citing
preteens and teenagers who hanged themselves or slashed their wrists shortly
after starting the antidepressants. Parent after parent described children
who had become extremely agitated or anxious shortly after starting the
antidepressants, and seemingly sudden impulses that turned deadly. FDA bowed to pressure from anguished families
who, at an emotional meeting last month, blamed the pills for their loved
ones’ suicides and pleaded for better warnings. The issue again made headlines when a 19-year-old
woman taking part in a study of Eli Lilly & Co.’s experimental new antidepressant duloxetine hanged herself in a company-run facility.
In the UK because only one drug,
Prozac,
has been proven to alleviate pediatric depression, it is the only one allowed
for use in children.
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Available evidence
Initially research of suicidal behavior
focused on children given these drugs. Among 25 studies of the suspect medications
involving 4,000 children and teens, there were no completed suicides. But
109 patients experienced one or more possibly suicide-related behaviors
or attempts, the FDA says.
The studies varied dramatically in what
was considered suicidal behavior, making a clear link difficult, FDA scientists
have contended. For example, among 19 patients classified as cutting themselves,
almost all were superficial, with little bleeding. Worse, the youths most likely to commit
suicide weren't allowed into those studies, so existing data likely won't
settle the issue, the FDA's scientific advisers have warned. It’s a difficult issue to sort out because
depression itself can lead to suicide, and studies clearly show that antidepressants
have helped many people recover from
depression.
The FDA had investigated reports of
suicide among adult antidepressant users in the early 1990s and
concluded there was no link — but has now revealed that it is
reanalyzing that question. Experts at Columbia University in New York
are providing an independent review of the studies, looking carefully at
descriptions of these events to determine whether those cases represent
suicidal behavior. There is an ongoing awareness that children are particularly vulnerable.
What to look for
In addition to looking for signs of worsening
depression, the following symptoms may also be a sign of a problem:
There also is concern
for people who have
bipolar disorder (manic depression) but don't know it.
antidepressants have the potential for provoking a manic episode in these
people, the FDA says. Doctors, patients, and family members should be on
the lookout for any symptoms of
mania, including feeling extremely happy
or very irritable, inflated self-esteem, not needing as much sleep as usual,
talking, or being more active than usual.
These changes should be
monitored especially at the beginning of treatment or when the doses are
increased or decreased.
Facts and numbers
Depression occurs in up to 10 percent of
youth, and 1,883 10- to 19-year-olds killed themselves in 2001. Some 1.8
million teenagers attempted suicide that year, a quarter of them requiring
medical attention, according to Columbia University scientists who are helping
the FDA's probe. In 2002, almost 11 million prescriptions
were dispensed to patients under 18 for SSRIs and other newer antidepressants,
to treat depression and a host of other conditions, FDA said.
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