In previous studies involving antidepressants (including Sarafem) and suicide, there appeared to be an increased risk of suicidal behavior in children and teenagers who took the medicine. Therefore, you should watch for any possible signs of suicidal behavior in yourself (or your child) while taking Sarafem. Some of the possible signs of suicidal behavior include depression or anxiety that is new or worse; agitation, restlessness, or panic attacks; and acting on dangerous impulses.
An Overview of Sarafem and Suicide
Sarafem® (fluoxetine hydrochloride) is a prescription medication that is used for the treatment of premenstrual dysphoric disorder (PMDD). It is part of a group of medications called selective serotonin reuptake inhibitors (SSRIs). Although Sarafem is not used to treat depression, it is classified as an antidepressant because of its actions. As with all antidepressants, there may be an increased risk of suicidal thinking and behavior when taking Sarafem.
Sarafem and Suicide: FDA Warning
The U.S. Food and Drug Administration (FDA) has issued a special warning about the risk of suicidal thoughts and behavior, known as "suicidality," with antidepressant use in children, adolescents, and young adults up to the age of 25. The warning was issued due to concerns that antidepressants seemed to increase the risk of suicidality in children, adolescents, and young adults in clinical studies.
While Sarafem is not approved for children or adolescents, it may be used "off-label" in these age groups.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Sarafem [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC;2013 July.
Prozac [package insert]. Indianapolis, IN: Lilly USA, LLC;2013 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. Medication Guide for Antidepressant Drugs. Available at http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/ucm100211.pdf. Accessed October 11, 2010.
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