Oct. 15, 2004,
FDA orders stringent antidepressant warningAssociated
WASHINGTON -- All antidepressants must carry a "black box"
warning, the government's strongest safety alert, linking the drugs
to increased suicidal thoughts and behavior among children and teens
taking them, the Food and Drug Administration said today.
Because the warnings are primarily seen by doctors, the agency
also is creating an information guide for patients to advise them of
"Today's actions represent FDA's conclusions about the increased
risk of suicidal thoughts and the necessary actions for physicians
prescribing these antidepressant drugs and for the children and
adolescents taking them," said Dr. Lester Crawford, acting FDA
The drug labels also include details of pediatric studies which,
thus far, have pointed to Prozac as the safest antidepressant for
youths to take.
On average, 2 percent to 3 percent of children taking
antidepressants have increased suicidal thoughts, independent
experts, working with Columbia University, found.
The FDA announcement follows to the letter guidance from federal
advisers. After searing and emotional public hearings one month ago,
the advisers urged the agency to add its most strident warnings to
The FDA said in a statement that it recognizes that depression in
pediatric patients "can have significant consequences in pediatric
patients if not appropriately treated. The new warning language
recognizes this need but advises close monitoring of patients as a
way of managing the risk of suicidality."
An information guide will be distributed with each antidepressant
prescription. Parents will be advised to look for warning signs in
children that include worsening depression, agitation, irritability,
and unusual changes in behavior. Those worrisome signs could come
within the first months of starting an antidepressant or when the
drug's doses changes -- higher or lower.
In 24 trials involving more than 4,400 patients taking
antidepressants, researchers found a greater risk of increased
suicidal thoughts and behavior during the first few months of
Celexa, Prozac and Zoloft posed lower risks for children,
researchers found, while Luvox, Effexor and Paxil had higher risks
of increased suicidal thoughts and behavior.
Prozac is the only antidepressant approved by the FDA for use for
treating depression in pediatric patients.
Anafranil, Prozac, Luvox and Zoloft have been used for treating
obsessive compulsive disorder in pediatric patients.
The new warnings, however, will be carried by all
antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta,
Desyrel, Effexor, Elavil, Lexapro, Limbitrol, Ludiomil, Luvox,
Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac,
Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax, Tofranil,
Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.
The agency's action comes at a time when it faces withering
criticism for not acting sooner on antidepressants, and for the
shortage of flu vaccine and the high-profile withdrawal of Vioxx for
Congressional investigations have focused on allegations the
agency silenced its own employees who tried to raise safety concerns
on the antidepressants and Vioxx.