Health
SSRI warning ordered by FDA
NEWS IN BRIEF — Posted Nov. 1, 2004
All antidepressant drugs will now carry labels that include a boxed warning alerting physicians and others to the increased risk of suicide they pose to children and adolescents, according to an Oct. 15 public health advisory issued by the Food and Drug Administration.
The warnings are to appear on more than 30 antidepressants including the popular selective serotonin reuptake inhibitors, or SSRIs, such as Prozac (fluoxetine), which is approved for treating manic-depressive disorder in children and Zoloft (sertraline), which is approved for obsessive compulsive disorder in children.
The FDA's action puts in force the recommendation made by its advisory panels in September. An analysis of SSRIs showed that the risk of such adverse events as having suicidal thoughts was twice as great for young patients on antidepressants as it was for those on placebo.
The warning is to include the following points: antidepressant drugs increase the risk of suicidal thinking and behavior in children and adolescents with psychiatric disorders; anyone considering using them for young people should weigh the risk versus the benefit; patients should be observed particularly closely when they start therapy; and families and caregivers should be advised to closely monitor children and speak frequently to the physician about any concerns.
Guides with information on the antidepressants will also be distributed by pharmacists with each new prescription or refill, said the FDA.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/11/01/hlbf1101.htm.
