Brisdelle and Suicide
The FDA black box warning is based on a review of several short-term clinical studies that showed young people under the age of 24 years old who took antidepressants appeared to have more suicidal thoughts and actions than those who did not take antidepressants.
For example, in one study, about 4 percent of children, teens, and young adults who took an antidepressant had suicidal thoughts and actions, compared to 2 percent of those not taking an antidepressant.
This increased risk for suicidal thoughts and actions was not seen in people over the age of 24. The risk was reduced in adults aged 65 and older.
The FDA looked at all suicidal behavior in these studies, including thoughts about suicides, talking about suicide, attempting suicides, and actual completed suicides. It is important to point out that suicidal thoughts and behaviors are not the same as suicide. In fact, 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 actually cause suicidal thoughts and behaviors. Certainly untreated depression and other mental illness are the most significant causes of suicidal thinking and behavior. Therefore, if suicidal thoughts and behaviors occur, it can be difficult to determine whether they are a result of an antidepressant medication, or the depression itself.
In clinical trials involving Brisdelle, three women taking Brisdelle reported suicidal thoughts, while one woman attempted suicide. There were no reports of suicidal thoughts or suicide attempts in women treated with placebo (a "sugar pill" with no active ingredient).
Everyone who is taking a medication used to treat depression, including women taking Brisdelle, should be carefully watched for any signs of suicidal behavior, especially in the first few months of treatment and after any dose changes (when the risk appears to be highest).
Let your healthcare provider know immediately if you experience any of the following symptoms:
- Any unusual changes in mood or behavior
- Thoughts about dying, suicide, or harming yourself
- Attempts to commit suicide
- New or worsening depression
- New or worsening anxiety or panic attacks
- Aggressive, angry, hostile, or violent behavior
- Acting on dangerous impulses
- Agitation, restlessness, or irritability
- Difficulty sleeping
- Unusual increases in activity or talking
- Any other unusual changes in mood or behavior.