- WASHINGTON (AP/CP) -- All
antidepressants must carry a "black box" warning ñ the
U.S. government's strongest safety alert ñ linking the drugs to
increased suicidal thoughts and behaviour among children and teens taking
them, the Food and Drug Administration said Friday.
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- Because the warnings are primarily seen by doctors, the
agency also is creating an information guide for patients to advise them
of the risk.
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- "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 commissioner.
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- The drug labels also include details of pediatric studies
which, thus far, have pointed to Prozac as the safest antidepressant for
youths to take.
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- On average, 2 per cent to 3 per cent of children taking
antidepressants have increased suicidal thoughts, independent experts,
working with Columbia University, found.
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- 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 stringent warnings to
the drugs.
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- 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."
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- 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 behaviour. Those worrisome signs could come within the first
months of starting an antidepressant or when the drug's doses changes ñ
whether higher or lower.
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- In 24 trials involving more than 4,400 patients taking
antidepressants, researchers found a greater risk of increased suicidal
thoughts and behaviour during the first few months of treatment.
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- Celexa, Prozac and Zoloft posed lower risks for children,
researchers found, while Luvox, Effexor and Paxil had higher risks of increased
suicidal thoughts and behaviour.
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- Prozac is the only antidepressant approved by the FDA
for use for treating depression in pediatric patients.
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- Anafranil, Prozac, Luvox and Zoloft have been used for
treating obsessive-compulsive disorder in pediatric patients.
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- 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.
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- The agency's action comes at a time when it faces withering
criticism for not acting sooner on antidepressants and for the high-profile
withdrawal of Vioxx over safety concerns.
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- Congressional investigations have focused on allegations
the that agency silenced its own employees who tried to raise safety concerns
on the antidepressants and Vioxx.
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- In June, Health Canada announced that antidepressants
including Wellbutrin, Zyban, Celexa, Prozac, Luvox, Remeron, Paxil, Zoloft
and Effexor would carry stronger warnings about possible emotional and
behavioural changes that could put users at risk of harming themselves
or others.
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