ALL antidepressants sold in the US will soon be required to carry a 鈥渂lack box鈥� warning on the packet, as well as a reader-friendly insert alerting people to the increased risk of suicidal tendencies in young patients, the Food and Drug Administration announced last week. A black box label is the most serious warning the FDA can issue.
The move follows advisory meetings in February and September on the evidence that children taking antidepressants are twice as likely to have suicidal tendencies as those on a placebo. The FDA looked only at trial data on five selective serotonin reuptake inhibitors (SSRIs) 鈥� the class of drugs that includes Prozac 鈥� and four other new antidepressants, but the warning applies to all antidepressants, including the older tricyclics.
鈥淭he 鈥榖lack box鈥� label is the most serious warning the FDA can issue鈥�
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For children, antidepressants are barely more effective than a placebo, so officials are reluctant to tolerate any serious risk. Last year the UK banned all antidepressants except Prozac for use in children and teenagers. But some think the FDA鈥檚 move will be more effective. 鈥淲e鈥檇 be much better off to have them clearly labelled,鈥� says David Healy, a psychiatrist at the North Wales Department of Psychological Medicine in Bangor, Wales, who helped uncover company data on the risks (New 杏吧原创, 3 July, p 36).