In studies, there was a slightly increased risk of suicidal thoughts or behavior in children and teenagers who took antidepressants. As an antidepressant, Viibryd (vilazodone) contains a warning in the package insert about this increased risk of suicidality. Be sure to contact your healthcare provider immediately if you notice any signs of suicidal behavior, such as acting on dangerous impulses or depression that gets worse.
The U.S. Food and Drug Administration (FDA) requires that all antidepressants have a black box warning (a special warning that appears on the package insert of the medication) highlighting the risk for suicidal thoughts and behaviors in children, adolescents, and young adults who take these medications. Because Viibryd is an antidepressant, it also carries this warning. Although this medication is not approved for use in children, it may be used "off-label" in this age group.
More Information on Suicide and Viibryd
The FDA reviewed short-term clinical studies of antidepressant use and found that young people under the age of 24 who took antidepressants appeared to have more suicidal thoughts and actions (called "suicidality") than those who did not take antidepressants. For example, in one study, about 4 percent of young people taking an antidepressant had suicidality, compared to 2 percent of those not taking an antidepressant.
This increased risk for suicidality was not seen in adults over the age of 24. In addition, adults aged 65 and older appeared to have a lower risk for suicidality when treated with an antidepressant.
It is important to keep in mind that "suicidality" is not necessarily the same as suicide. Suicidality describes thoughts and actions related to suicide, such as thinking about suicide, talking about suicide, or attempting suicide. None of the children or adolescents actually committed suicide in the clinical studies reviewed by the FDA.
It is difficult to know for sure if antidepressants cause suicidality. Depression and other mental health problems can contribute to suicidal thoughts and behaviors, and it can be difficult to tease out the effects of the illness from the effects of the medication. Certainly depression and serious mental illness are the most important causes of suicidal thinking and behavior.
The risk for suicidality with antidepressant use may be highest at the beginning of treatment or with dose changes. Also, certain people may be at a higher risk for suicidality while taking antidepressants. This includes people with bipolar disorder or a family history of bipolar disorder and people who have attempted suicide in the past or have a family history of suicide attempts.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Viibryd [package insert]. St. Louis, MO: Forest Laboratories, Inc.;2012 December.
Viibryd Medication Guide. New Haven, CT: Trovis Pharmaceuticals LLC.;2010 January.
Friedman RA, Leon AC. Expanding the Black Box -- Depression, Antidepressants, and the Risk of Suicide. NEJM 2007; 356: 2343-46.
U.S. Food and Drug Administration. Revisions to Product Labeling. Suicidality and Antidepressants. Available at http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm096273.htm. Accessed January 26, 2011.
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