June 20 -- The FDA yesterday warned that children younger than 18 should not take the antidepressant Paxil because of a possible increased risk of "suicidal thinking and suicide attempts" associated with the drug. This statement from the FDA came on the heels of a similar warning on June 10 by British regulators. The drug is known as Seroxat in the UK.
Quote: "There is currently no evidence that Paxil is effective in children or adolescents with MDD (major depressive disorder), and Paxil is not currently approved for use in children and adolescents." (FDA Statement)
Our Comment: In the US, the FDA permits physicians to prescribe approved medications for other than their intended indications. This practice is known as off-label use. Although there is practical merit in off-label use, the current situation surrounding Paxil illustrates one of the dangers of off-label drug usage.
For additional information please visit the following MedicineNet.com areas:
- paroxetine (Paxil)
- Depression in Young and Teenage Boys
- 9 Symptoms of Depression
- Depression Myths
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- Depression Center
- Focus Topics on Depression
- Focus Topic on Healthy Kids, edited by Frederick Hecht, MD, FAAP, FACMG, Pediatrician, Medical Geneticist, and up-to-date on children's health issues.
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.
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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.
Source: FDA Talkpaper # T03-43, June 19, 2003
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Last Editorial Review: 6/20/2003