Sarafem and Suicide

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. As with all antidepressants, there may be an increased risk of suicidal 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 with antidepressant use in children and teenagers. The warning was issued due to concerns that antidepressants seemed to increase the risk of suicidal behavior in children and teenagers in clinical studies.
 
While Sarafem is not approved for children or adolescents, it may be used "off-label" in these age groups.
 

Does Sarafem Cause Suicides?

In clinical studies, it did appear that there was a slightly increased risk of suicidal behavior in children and teenagers who took antidepressants, including Sarafem.
 In one study, about 4 percent of children and teens taking an antidepressant had suicidal thoughts or behavior, compared to 2 percent in children and teens who were not taking an antidepressant. This study looked at all suicidal behavior, including suicides, attempted suicides, and thoughts about committing suicide. It is important to note that no one in the study actually committed suicide.
 
It is difficult to know for sure if antidepressants cause suicidal behavior. To make matters more confusing, depression itself can cause suicidal behavior. The bottom line: you should report any signs of suicidal behavior to your healthcare professional, whether you are taking an antidepressant or not.
 
Certain people seem to be at a higher risk for suicidal behavior while taking antidepressants. This includes people with bipolar disorder (or a family history of bipolar disorder) and people who have attempted suicide (or have a family history of suicide attempts).
 
(Sarafem and Suicide Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;