|
 FDA
Issues Warning on Antidepressants
Possible Suicide, Severe Depression, Anxiety, Panic Attacks
in Children and Adults
by Jeanie Lerche Davis, WebMD Medical News, March 22,
2004
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https://www.bridges4kids.org.
The FDA is issuing a warning about the possibility of worsening
depression or suicidal thoughts in people, particularly
children, who take any of 10 popular antidepressants, especially
at the beginning of treatment or when the doses are increased or
decreased.
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
adults and children.
Antidepressants involved in this warning label request
are:
Prozac (also sold generically as fluoxetine)
Zoloft
Paxil
Luvox
Celexa
Lexapro
Wellbutrin
Effexor
Serzone
Remeron
"We don't know that the drugs are responsible for these
behavioral changes, but nonetheless we're telling physicians and
families to be aware of this and that if the behaviors do
emerge, to get treatment right away," said Russell Katz, a
director with the FDA's Center for Drug Evaluation and Research,
in a news teleconference today.
The proposed warning label will "include information about
behavioral changes that may occur in patients who are prescribed
antidepressant drugs," said Katz.
"This applies to adult and pediatric patients and involves the
potential for suicidal thinking or suicidal behaviors and warns
the physician and family about any behaviors that might emerge
that haven't been experienced before," he added.
But the FDA stopped short of recommending people discontinue
taking their antidepressants.
"We specifically decided not to tell people not to use these
drugs," said Katz. "We don't think that is necessary at this
point."
In addition to looking for signs of worsening depression,
the following symptoms may also be a sign of a problem:
Anxiety
Agitation
Panic attacks
Insomnia
Irritability
Hostility
Impulsivity
Severe restlessness
Mania in both adults and children being treated with
antidepressants for major depression
If these changes appear, treatment should be evaluated, the FDA
says. Medications may need to be discontinued when symptoms are
severe, begin abruptly, or if they signal a new disorder.
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.
Reviewing Studies of Children
The FDA has been closely reviewing studies of antidepressants in
children for the past year after an initial report on studies of
Paxil and other drugs suggested an increased risk of suicidal
thoughts in children given antidepressants. No suicides occurred
in any of the trials, the FDA reports.
The analysis has involved 25 controlled trials with 4,000
children taking antidepressants, said Katz. "Those reviews are
ongoing."
Today's action "arose from an unexpected observation in some
studies of an apparent excess of emotionability, a catch-all
term ... that includes suicidal [thoughts]," said Robert Temple,
MD, the FDA's director of medical policy.
However, closer examination has shown that the accounts are
unclear -- whether certain behaviors reported were actual
suicide attempts or other self-injurious behavior that was not
suicide-related.
"As we've gone into the studies in detail, it's become evident
that the terms used were highly varied and [the studies] not
very well done," Temple said.
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.
"We hope to have a much better idea whether these drugs are
effective and whether or not they do cause suicidal symptoms,"
said Katz.
"There is an ongoing awareness that children are particularly
vulnerable, that they need additional protection, and that we
make sure that all the protections are in place," said Dianne
Murphy, MD, the FDA's director of Pediatric Therapeutics.
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