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FDA Statement Regarding Paxil for Pediatrics

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T03-43

June 19, 2003

Media Inquiries: 301-827-6242

Consumer Inquiries: 888-INFO-FDA

FDA Statement Regarding the Anti-Depressant Paxil for Pediatric Population

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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