Connecticut Dept of Children & Families Bans Paxil
Tue, 26 Aug 2003
The New Haven Register reports that the Connecticut Department of Children and Families (DCF) is the first state agency to ban the use of Paxil in children to protect from harm.
Public disclosure of evidence demonstrating Paxil's suicide risk led the UK government to ban the drug for children in June. It also led the manufacturer, GlaxoSmithKline, to send healthcare professionals in the UK a letter warning them about both the suicide risk for children and withdrawal symptoms--which are a sign of addiction.
The company has issued no such warning letter to US healthcare workers. The Connecticut DCF is to be commended for taking action to protect children from a harmful drug. Since GlaxoSmithKline did not disclose the risks of its drug, its officials should not be allowed to apply pressure to on DCF officials.
Paxil maker to meet with state as Department of Children and Families bans its use
Associated Press 08/26/2003
HARTFORD - The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the state stopped using the drug to treat young people in its care.
GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families.
In July, DCF became the first public child protection agency to ban Paxil after the U.S. Food and Drug Administration recommended the drug not be given to anyone under 18. The FDA said there could be severe negative effects for children, including an increased risk of suicide.
The British government also issued a strong warning against pediatric use of the anti-depressant, sold there under the name Seroxat.
Maribel Vazquez, DCF program supervisor for the Bureau of Child Welfare Services, said last month the department is stopping use of Paxil for six months pending further study.
DCF will recommend children on Paxil switch to safer alternative treatment, if one is available.
Department officials wouldn't reveal how many of the nearly 8,000 children in their care are prescribed Paxil or other selective serotonin reuptake inhibitors, saying that would violate patient privacy rights.
The FDA has never approved use of Paxil in children or teens.
But some doctors prescribe the adult drug for children.
The FDA asked all makers of adult antidepressants to submit research showing how their drugs affect children. Three studies of Paxil found it didn't seem to help pediatric depression - but FDA scientists spotted some safety concerns and ordered manufacturer Glaxo-SmithKline to re-analyze the data.
That re-analysis found the risk of suicidal thoughts and suicide attempts was three times greater among Paxil users, mostly teens, than among children given placebo pills, the FDA said.
©New Haven Register 2003
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