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New Warnings for Young Adults on Antidepressant Medications

Ijeoma Eleazu, PharmD

Today the FDA made a propsoal to all manufacturers of antidepressant medications to update the black box warnings on their products to include warnings about the increased risks of suicidal thinking and behavior (aka suicidality) in young adults between the ages of 18 and 24 during initial treatment.

First of all, what is Black box warning? Well, it literally is a black box on the package insert of a drug. According to the FDA, it is used to highlight special problems, and in particular, those that are serious and is meant to give healthcare professionals a clear understanding of any potential medical complications associated with a drug. The whole point is to enable practitioners to prescribe the medication in a way that maximizes the benefits and minimizes the risks of the drug. Secondly, what time period is considered the "initial treatment" phase? Again according to the FDA it is generally the first one to two months of treatment.

The scientific data which this new warning is based on did not show this increased risk in those over age 24 and that adults 65 years of age and older who were taking antidepressants have a decreased risk of suicidality. What does all this mean to people taking these medications. Well first off, don't stop taking them without first consulting your healthcare provider and if you have any concerns you should definitely notify him or her.

For a list of products involved in today's action click here.

Photo courtesy of Emuishere Peliculas

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