DCF, Pharmaceutical Company To Discuss Paxil Ban
State Agency Was First Public Agency To Stop Using DrugAug 26, 2003 | www.nbc30.com 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 GlaxoSmithKline to reanalyze the data. That reanalysis 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.