Why the Black Box Warning on Antidepressants Backfired

In October 2004, the FDA issued a black box warning — to appear at the top of the package insert given out with antidepressant prescriptions — advising patients of a small risk that the drugs could increase the risk of suicidal thoughts and behaviors in teenagers. In 2007, the FDA extended that warning to young adults. But according to a new study recently published in the British Medical Journal, that black box warning may have backfired — leading to a drastic increase in suicide attempts among both teens and young adults. Why? Pediatric psychiatrists say that news reports of the risks of antidepressant drugs for teens and young adults may have made prescribing physicians and their families overly wary of the medications. Though the FDA did revise the black box warning to remind physicians and patients that the risks of untreated depression outweigh the risks associated with antidepressants, the study authors believe that the publicity surrounding the black box warning may serve as an obstacle to appropriate depression treatment for many young people. When it comes to antidepressants for young people, the benefits far outweigh the risks; if your doctor has recommended antidepressants for you or a young person in your life choose a trusted online pharmacy to fill your prescription.

Suicide Attempts Increase Following Black Box Warning

For the recent study, researchers at Harvard Medical School examined data on suicide attempts across the country between the year 2000 and 2010. They examined insurance data on 7.5 million people, including 1.1 million teens, 1.4 million young adults and 5 million adults. To measure rates of attempted suicide, the researchers looked at nonfatal, psychotropic drug overdoses, not including narcotic drug overdoses, since drug overdoses are the most consistently reliable, measurable type of suicide attempt. The researchers found that the implementation of the black box warning precipitated a 21.7 percent increase in suicide attempts among teens and a 33.7 percent increase in suicide attempts among young adults. That’s an additional two to four attempts per 100,000 people. Antidepressant use among teens and young adults fell by 20 percent during the six years following the institution of the black box warning. The rate of actual suicides, which are much rarer than suicide attempts, remained about the same, the researchers found.

The Antidepressant-Suicide Risk Has Been Overblown

The FDA based its decision to institute a black box warning for antidepressants on a thorough review of the data available at the time, which showed about of teens and young adults taking the medication for depression experience an increase in suicidal thoughts and behaviors. While this is certainly a cause for concern, it’s also worth pointing out that a young person’s risk of experiencing increased suicidal thoughts on antidepressants is small. It’s certainly much smaller than the risk of suicidal thoughts and behaviors in young people suffering from untreated or undertreated depression. Pediatric psychiatrists believe that the extensive media coverage of the slightly increased risk of suicidal thoughts among young people taking antidepressants directly contributed to the decline in antidepressant use among young people and the increase in suicide attempts among that same age group. Christine Y. Lu, the study’s lead author and a researcher at Harvard Medical School’s Department of Population Medicine and the Harvard Pilgrim Health Care Institute, , “It was so intensely and widely publicized, the warning had more impact than it really should have.” Senior author Stephen Soumerai, professor of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, believes the publicity may have had a profound and lasting effect on the way doctors prescribe antidepressant medications. He points out that the increase in suicide attempts during the first years after the implementation of the warning can be blamed on the media coverage. But, , “The increase in suicide attempts continued, and it doesn’t look like the decrease in antidepressant use has lessened much over the years, suggesting the warning and media coverage caused a large change in prescribing habits.” Child psychiatrist Dr. Louis Kraus, who was not involved with the study, believes the warning itself scares parents. “There are families that see the black box warning and don’t want their children on drugs, and that has impacted treatment,” he told NBC News.

Untreated Depression Riskier Than Antidepressants

Untreated depression is the leading cause of suicide, which is the cause of death in young people between the ages of 15 and 24. The study’s authors, as well as the black box warning itself, point out that the risks of leaving depression untreated or inadequately treated far outweigh the risks of using antidepressant drugs. Not all young people struggling with depression need antidepressants, but most do. While the best course of treatment is a combination of drugs and therapy, many young people who have access to antidepressants through a primary care provider may not have access to psychotherapy. A young person who is denied antidepressants may therefore get no treatment at all. While suicide attempts are rarely successful, they can still require weeks of hospitalization that both disrupts a young person’s life and threatens the family’s financial stability.