FDA again reviews antidepressants
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《英国医生杂志》
The US Food and Drug Administration is considering tougher warnings about antidepressant drugs in children. The drugs have been linked to almost double the risk of suicide.
The FDA will hold public meetings on the subject in mid-September. Labelling changes and other regulatory actions are possible. The data are not "black and white," said Dr Thomas Laughren, team leader of psychiatric drug products at the FDA.
In addition, a front page New York Times article headlined "Boy's Murder Case Entangled in Fight Over Antidepressants" noted the FDA's examination of antidepressants in children and adolescents and said the drugs were the subject of a national debate. The article said the drugs might cause aggressive and violent behaviour ( New York Times 23 Aug 2004: A1). Only fluoxetine is approved for treating depression in children in the United Kingdom and the United States.
As the FDA again reviews antidepressants in children, Christopher Pitttman, who took sertraline and paroxetine, faces trail for murder
Credit: JIM STRATAKOS/THE HERALD
The boy in the murder case, Christopher Pittman, came from a troubled family. When his parents broke up, he said he might kill himself, and he was admitted to hospital and began treatment with paroxetine for a few days.
He was then treated with sertraline and sent to live with his grandparents in a small town in South Carolina in 2001. At first, Christopher, then aged 12, managed well. But a few weeks later he got into an argument on a school bus and then with his grandparents. That night he shot dead his grandparents, set their house on fire, and stole money and their car.
According to the New York Times, Christopher will be tried as an adult. If convicted, he could be jailed for life. His lawyers say he committed the murders because of sertraline.
Use of antidepressant drugs in children and teenagers is controversial both in the United Kingdom and in the United States.
The FDA began reviewing studies of antidepressant use in children in 2003, and the US controversy erupted in late 2003 when British authorities warned doctors that the newer antidepressants, particularly selective serotonin reuptake inhibitors, might increase the risk of suicidal thoughts and actions in children and teenagers.
In March 2004 the FDA cautioned doctors to monitor all patients closely for risk of suicide, especially when they began taking antidepressants or changed dosage. Doctors were warned about the high risk in patients with bipolar depression or a family history of bipolar disorder. The FDA also asked companies to add warning statements, which they did.
The FDA asked suicide experts from Columbia University in New York to review the studies of almost 4000 children and teenagers. They came to conclusions similar to those reached by the FDA's experts: the drugs increased suicidal thoughts and behaviours. No children in the review committed suicide.
Earlier this month, the BMJ and others reported that the FDA had suppressed documents showing that Dr Andrew Mosholder, an expert with the FDA's Office of Drug Safety, found that children taking antidepressants were almost twice as likely to become suicidal as children taking placebo (7 August, p 307).(Janice Hopkins Tanne)
The FDA will hold public meetings on the subject in mid-September. Labelling changes and other regulatory actions are possible. The data are not "black and white," said Dr Thomas Laughren, team leader of psychiatric drug products at the FDA.
In addition, a front page New York Times article headlined "Boy's Murder Case Entangled in Fight Over Antidepressants" noted the FDA's examination of antidepressants in children and adolescents and said the drugs were the subject of a national debate. The article said the drugs might cause aggressive and violent behaviour ( New York Times 23 Aug 2004: A1). Only fluoxetine is approved for treating depression in children in the United Kingdom and the United States.
As the FDA again reviews antidepressants in children, Christopher Pitttman, who took sertraline and paroxetine, faces trail for murder
Credit: JIM STRATAKOS/THE HERALD
The boy in the murder case, Christopher Pittman, came from a troubled family. When his parents broke up, he said he might kill himself, and he was admitted to hospital and began treatment with paroxetine for a few days.
He was then treated with sertraline and sent to live with his grandparents in a small town in South Carolina in 2001. At first, Christopher, then aged 12, managed well. But a few weeks later he got into an argument on a school bus and then with his grandparents. That night he shot dead his grandparents, set their house on fire, and stole money and their car.
According to the New York Times, Christopher will be tried as an adult. If convicted, he could be jailed for life. His lawyers say he committed the murders because of sertraline.
Use of antidepressant drugs in children and teenagers is controversial both in the United Kingdom and in the United States.
The FDA began reviewing studies of antidepressant use in children in 2003, and the US controversy erupted in late 2003 when British authorities warned doctors that the newer antidepressants, particularly selective serotonin reuptake inhibitors, might increase the risk of suicidal thoughts and actions in children and teenagers.
In March 2004 the FDA cautioned doctors to monitor all patients closely for risk of suicide, especially when they began taking antidepressants or changed dosage. Doctors were warned about the high risk in patients with bipolar depression or a family history of bipolar disorder. The FDA also asked companies to add warning statements, which they did.
The FDA asked suicide experts from Columbia University in New York to review the studies of almost 4000 children and teenagers. They came to conclusions similar to those reached by the FDA's experts: the drugs increased suicidal thoughts and behaviours. No children in the review committed suicide.
Earlier this month, the BMJ and others reported that the FDA had suppressed documents showing that Dr Andrew Mosholder, an expert with the FDA's Office of Drug Safety, found that children taking antidepressants were almost twice as likely to become suicidal as children taking placebo (7 August, p 307).(Janice Hopkins Tanne)