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| ADVISORY: DESPITE THE NEW POSSIBLE SAFETY CONCERNS ABOUT USE OF PAXIL IN CHILDREN, IT IS ESSENTIAL THAT PATIENTS TAKING PAXIL (paroxetine hydrochloride) DO NOT SUDDENLY DISCONTINUE USE OF THE DRUG. ANY CHANGES MUST TAKE PLACE UNDER MEDICAL SUPERVISION. |
The Food and Drug Administration (FDA) said today it is reviewing reports of
a possible increased risk of suicidal thinking and suicide attempts in children
and adolescents under the age of 18 treated with the drug Paxil for major
depressive disorder (MDD). Although the FDA has not completed its evaluation of
the new safety data, FDA is recommending that Paxil not be used in children and
adolescents for the treatment of MDD. There is currently no evidence that Paxil
is effective in children or adolescents with MDD, and Paxil is not currently
approved for use in children and adolescents. Other approved treatment options
are available for depression in children.
Paxil is approved for use in
adults for the treatment of Obsessive Compulsive Disorder (OCD), MDD, Panic
Disorder, Social Anxiety Disorder (SAD), Generalized Anxiety Disorder, and
Post-traumatic Stress Disorder. There is no evidence that Paxil is associated
with an increased risk of suicidal thinking in adults.
Three well-controlled trials in pediatric patients with MDD failed to show
that the drug was more effective than placebo. The new safety information that
is currently under review was derived from trials of Paxil in pediatric
patients.
Following its review of the same data, the UK Department of Health
issued a Press Release on June 10 stating that paroxetine (brand name Seroxat in
the UK) must not be used to treat children and teenagers under the age of 18
years for depressive illness because UK authorities have concluded that there is
an increase in the rate of self harm and potentially suicidal behavior in this
age group, when paroxetine is used for depressive illness.
FDA advises that caretakers of pediatric patients already receiving treatment with Paxil for MDD talk to their doctor before stopping use of the drug. Patients should not discontinue use of Paxil without first consulting their physicians, and it is important that Paxil not be abruptly discontinued.
More information about today's statement is available at http://www.fda.gov/cder/drug/infopage/paxil/default.htm
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