David Baxter PhD
Late Founder
Antidepressant black box suicide warnings to be extended to young adults
In suicidal ideation
The U.S. Food and Drug Administration (FDA) has proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."
People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.
The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.
The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.
Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.
In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.
Comment from Anxiety Insights:
As Anxiety Insights reported recently, new research using a much larger data set than the FDA cited studies found the incidence of suicidal behavior in antidepressant treated children and adolescents was about the same as in those given placebos. Furthermore, when compared to the findings of an earlier study by the same authors which looked into suicidality in adolescents treated with psychotherapy alone, antidepressants appear to be slightly less risky.
Recent research has also found that there are large variations in suicidal behavior - up to 10 fold - in studies for both the antidepressant and placebo treated patients. Such large variability must put a huge question mark over the conclusions reached by the meta analysis research that has fueled the antidepressant-suicide debate. The authors concluded that it would need data from some two million patients to determine if antidepressants do increase suicidal behavior, considerably more than the tens of thousands in the FDA cited studies.
After black box warnings were first mandated in 2004 the U.S. Center for Disease Control noted a 12% rise in youth suicides, the first in more than a decade. The equates to an additional 248 deaths annually in the United States, and possibly several thousand worldwide. While the FDA has sought to balance the message in the current proposal by emphasizing that untreated mental illness is far and away the leading cause of suicide, this is, sadly, likely to lost as the proposal propagates through the media.
In suicidal ideation
The U.S. Food and Drug Administration (FDA) has proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."
People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.
The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.
The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.
Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.
In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.
Comment from Anxiety Insights:
As Anxiety Insights reported recently, new research using a much larger data set than the FDA cited studies found the incidence of suicidal behavior in antidepressant treated children and adolescents was about the same as in those given placebos. Furthermore, when compared to the findings of an earlier study by the same authors which looked into suicidality in adolescents treated with psychotherapy alone, antidepressants appear to be slightly less risky.
Recent research has also found that there are large variations in suicidal behavior - up to 10 fold - in studies for both the antidepressant and placebo treated patients. Such large variability must put a huge question mark over the conclusions reached by the meta analysis research that has fueled the antidepressant-suicide debate. The authors concluded that it would need data from some two million patients to determine if antidepressants do increase suicidal behavior, considerably more than the tens of thousands in the FDA cited studies.
After black box warnings were first mandated in 2004 the U.S. Center for Disease Control noted a 12% rise in youth suicides, the first in more than a decade. The equates to an additional 248 deaths annually in the United States, and possibly several thousand worldwide. While the FDA has sought to balance the message in the current proposal by emphasizing that untreated mental illness is far and away the leading cause of suicide, this is, sadly, likely to lost as the proposal propagates through the media.
