The U.S. Food and Drug Administration has issued a black box warning for those who take Fetzima (levomilnacipran), as this drug may increase suicidal thoughts or behavior in certain people. This risk appears to be highest for children, adolescents, and young adults under age 24. Suicidal thoughts and actions seem to be highest when first starting the antidepressant or when the dosage is adjusted.
Like all antidepressants, Fetzima may increase suicidal thoughts or behavior in certain people. This is sometimes called "suicidality."
The FDA Warning About Fetzima and Suicidality
When the U.S. Food and Drug Administration (FDA) determines that a medication is associated with a potentially serious or life-threatening risk, they issue a boxed warning, also called a black box warning. This warning, which has a black border around it, appears on the medication's prescribing information to draw attention to the potential safety concerns of using the drug. A black box warning is the strongest FDA warning.
The FDA requires a black box warning to be included in all antidepressant prescribing information, highlighting the increased risk for suicidal thoughts and behaviors in children, adolescents, and young adults who take these medications. Even though Fetzima is not approved for use in children younger than 18 years of age, it could be used "off-label" in this age group.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Fetzima [package insert]. St. Louis, MO: Forest Pharmaceuticals, Inc.;2013 July.
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/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM173233.pdf. Accessed August 9, 2013.
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