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Paxil: Children
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The FDA issued a Public Health Advisory in October 2003 about increased reports of suicidal thinking, suicide attempts, hostility and self-harm in children using Paxil. The FDA urges that Paxil be used with caution in children. Parents of children using Paxil should consult the prescribing physician immediately to discuss the suicide risks involved in taking Paxil.
A: Over the last few years, the FDA has worked closely with manufacturers of all marketed antidepressants (including Paxil) to fully evaluate the risk of suicidality in children, adolescents, and adults treated with these medications. Paxil maker GlaxoSmithKline added a black box warning to Paxil prescribing information describing the increased risk of suicidal thoughts and behavior in children and adolescents taking antidepressants. Click here for more information.
Senator Schumer noted in a letter to the FDA about Paxil that the British government's health agency already had banned sales of Paxil to children and adolescents. He questioned why the British company should be allowed to sell the drug in the United States to children when it already was banned by the British government.
In September 2004, the FDA issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. This follows a report issued by Britain's Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil. British health regulators recently issued a warning and stated: "It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks." Following their British counterparts, Irish health officials issued a warning for Paxil in Ireland, and the FDA continues to investigate the suicide risk associated with Paxil and other antidepressants.
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