FDA May Expand Antidepressant Warning
Studies Show Risk of Suicidal Behavior for Some Antidepressants May Apply to Young Adults
Dec. 13, 2006 -- The FDA said Wednesday it planned to expand warnings on up
to a dozen antidepressant medications following studies suggesting the drugs
raise the risk of suicidal behavior in a wider range of patients than
In 2004, the agency ordered "black box" warnings to be added to
antidepressant packaging alerting doctors of evidence that the drugs increase
the risk of suicidal thoughts and attempts in children and teens under the age
of 18. Officials said Wednesday they would now move to expand the warning to
include young adults up to age 25.
The warnings apply to selective serotonin reuptake inhibitors (SSRIs) such
as Prozac and Paxil, in addition to related drugs including Effexor and
Wellbutrin. Officials said the warnings would also likely be included in
medication guides distributed to patients
Antidepressants and Young People
Adult antidepressant studies have suggested that adults, up to the age of
24, who take antidepressants are more than twice as likely to think about or
attempt suicide as adults taking a placebo.
An analysis of 372 studies performed by the FDA showed no evidence of any
completed suicides that can be blamed on the drug. The analysis also showed
that suicidal ideas and behaviors remain relatively rare.
The regulators pointed to a consistent trend, which is highest in children
and then tapers off through early adulthood.
"There's nothing magical about 25. It's not like this goes away the day
you turn 25," said Marc B. Stone, MD, a medical reviewer in the FDA's
division of psychiatric products. "But the risk seems fairly flat in the 25
to 64 range and pretty steep in the 18 to 24 range," he told an advisory
panel called to review the warnings. "We can't ignore it."
The FDA estimated in 2004 that antidepressants cause suicidal thoughts and
behaviors in an additional 14 children for every 1,000 who take them. The
agency concluded Wednesday that less than a third as many young adults may face
that additional risk.
Elusive Explanation of Risk
But officials and other researchers acknowledged that any biological
explanation for the increased risk is elusive. Widespread use of
antidepressants is credited with helping to lower the risk of suicide attempts
or completion in the population at large.
Experts at the meeting said it is possible that the drugs spur suicidal
behavior at the beginning of treatment in younger patients, only to help stave
it off later as depression or other mental disorder symptoms
wane. They add that a greater proclivity toward impulsiveness in younger people
could be to blame.
On the other hand, antidepressants may merely make young patients more
communicative, making it more likely that they relate suicidal thoughts to a
parent or doctor.
"We don't know enough to be surprised or not surprised," said Robert
Temple, MD, director of FDA's office of drug evaluations.