If you’re one of the many people who takes an antidepressant to ease your depression, you might be taking a medication whose package insert carries a U.S. Food and Drug Administration (FDA) mandated “black box warning” label. This label cautions users about an increased risk of suicidal thoughts and behavior among children, teens, and young adults that’s been linked to taking the drugs. 

This black box warning label has been carried on antidepressant medications in the classes known as selective serotonin or serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs) since 2004 (for children and teens) and 2006 (for young adults ages 18-25). This class of medications includes such commonly used antidepressants as Prozac, Zoloft, Celexa, and Effexor. The FDA required the warning after several industry-sponsored studies uncovered the increased risk for suicidal behavior as an ironic side effect to taking these meds to treat depression. 

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But now a new study by researchers at the University of Chicago is casting doubt on the studies that triggered the FDA’s warning label, saying that the first studies didn’t take into account how well the drugs were working to reduce users’ depression symptoms.  If the drugs worked to relieve depression, the risk of suicidal thoughts and behaviors actually appears to decrease, they say, not increase. But if the depression is not brought under control – by the medications or other means – the risk of suicidal ideation remains elevated.

What is a “Black Box Warning” Label?

According to the Code of Federal Regulations, 21CFR201.57(e), “Special problems, particularly those that may lead to death or serious injury, may be required by the U.S. Food and Drug Administration to be placed in a prominently displayed box.”  That means that if the FDA is alerted to clinical data – even animal studies – that appear to link a medication with a potentially life-threatening condition, FDA officials will require that people taking the drug be warned about this potential side effect.

A black box warning on a medication doesn’t mean patients shouldn’t take the medication or that a doctor should stop prescribing it. But it does mean that a doctor – and his or her patient, in their discussions about treatment – should consider the risks and benefits of the drug when deciding on a course of treatment.

Prozac’s Black Box Warning Label

What Triggered the Antidepressant Black Box Warning?

The FDA’s move to require a black box warning on antidepressant medications was triggered by a series of inquires that started in 2003 with an investigation into a clinical trial on the use of Paxil in children.  Reports had shown that a small percentage of children in this trial had shown signs of increased suicidal behavior, and FDA officials were so concerned by this finding that they asked drugmakers of this med and eight others to look at all their pediatric drug trial data to see if there was a pattern to this suicidal behavior/antidepressant link.