Brisdelle and Suicide
Does taking Brisdelle (paroxetine mesylate capsules) increase your risk of suicide? The U.S. Food and Drug Administration has issued a "black box warning" for antidepressants, as they may increase the risk for suicidal thoughts and behavior. Although Brisdelle is not approved to treat depression or other mood disorders, it does contain the same active ingredient found in many antidepressants.
Brisdelle™ (paroxetine mesylate capsules) is a prescription medication approved to reduce hot flashes that are caused by menopause. It contains paroxetine, a selective serotonin reuptake inhibitor. Paroxetine is also the active ingredient in medications used to treat depression, including Paxil® (paroxetine), Pexeva® (paroxetine mesylate), and Paxil CR® (paroxetine controlled release).
All medications approved to treat depression carry a special precaution, which warns people that the medicine may increase the risk for suicidal thoughts and behavior. Even though Brisdelle is not approved to treat depression, it contains paroxetine and, therefore, also carries this special warning.
When the U.S. Food and Drug Administration (FDA) determines that a medication is associated with a potentially serious or life-threatening risk, it issues a special warning known as a "boxed warning" (also sometimes referred to as 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 medication. A black box warning is the strongest of all the FDA warnings.
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. It should be noted that Brisdelle is not approved for use in children younger than 18 years of age.