New Warning for Young Adults Taking Antidepressants
It's been known for some time that children and teenagers taking antidepressants are at higher-than-average risk of feeling suicidal impulses during the early weeks of treatment. Now, young adults should be on guard, too. That's the conclusion of a panel of experts convened Wednesday by the Food and Drug Administration to evaluate new data on suicide risks and antidepressants. The committee recommended that the "black box" warning on the medications concerning the risks to youngsters be expanded to include people up to age 25. The FDA will have to officially implement the change, but it usually follows the recommendations of its advisory committee.
To perform the analysis, the agency called on manufacturers of the 12 most popular antidepressants (including Prozac, Paxil, and Zoloft) to submit data on suicide-related events such as thoughts, attempts, and self-injury among participants in their clinical trials. FDA scientists then reviewed data collected from more than 77,000 adults and found no significant increase in overall suicide risk among those who took antidepressants compared with those who took placebos. The data did show, however, an increase in suicidal behavior and thoughts among users ages 18 to 24. For every 1,000 young adults who took the medications, an extra four experienced these tendencies compared with those who took placebos. The increased risk disappeared between ages 25 and 30 and fell below that of the placebo group after age 30. The biggest benefits from antidepressants compared with the control group were found in those over 65.
"The observed relationship between antidepressants and suicidality is strongly related to age," says Marc Stone, a senior medical reviewer for the FDA who presented the findings at the meeting. "A preventative effect tends to predominate in older subjects whereas in younger subjects the opposite is true." Although the analysis couldn't explain why age would make a difference, it's consistent with earlier data showing a twofold increase in suicidal thinking and behavior among children and teenagers during the first few months of treatment, which prompted the FDA to add the black-box warning in 2004.
Mental health organizations strongly object to the label warnings, citing statistics that show that more than half of all people with depression don't get the help they need and that untreated depression carries a 15 percent lifetime risk of suicide–far greater than any risk associated with antidepressants. "The black box carries so much weight in terms of indicating a level of danger associated with using a pharmacologic agent," says psychologist David Sherm, president of Mental Health America, a nonprofit patient advocacy group. "We don't want to scare people away from effective treatment."
Prescriptions written for antidepressants in children have declined by 20 percent since the warning was added, and the American Psychiatric Association (which also opposes the black-box warning) has pointed out that this may be having an unwanted effect. A study published in the November issue of the American Journal of Psychiatry found that those U.S. counties that have the highest antidepressant prescription rates in youngsters have the lowest rates of child and adolescent suicides.
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