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Date you started taking this drug:

Date you stopped taking this drug:

Age of patient when antidepressant(s) prescribed:

What condition was this medication prescribed to treat?

What additional medications were you taking at the time?

Did patient hurt themselves during or after taking the drug?

Did patient become violent during or after taking the drug?

Was suicide attempted?

Was hospitalization or institutionalization required after taking antidepressant(s)?

Did loved one commit suicide?

If patient did attempt or commit suicide, did patient ever attempt suicide previously?

If patient did commit suicide, what was the method of suicide?

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FDA Statement Regarding The Anti-Depressant Paxil for Pediatric Population

Aug 1, 2003 | Doctor's Guide, NY

The Food and Drug Administration (FDA) 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.

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