A so-called “black box” warning on antidepressants that the medications increase the risk of suicidal thinking and behavior in kids may have had a horrible side-effect. New research finds the warning backfired, causing an increase in suicide attempts by teens and young adults.
After the FDA advisories and final black box warning that was issued in October 2004 and the media coverage surrounding this issue, the use of antidepressants in young people dropped by up to 31 percent, according to the study published Wednesday in the British Medical Journal.
That drop in use resulted in a 22 percent increase in suicide attempts among adolescents and a 34 percent increase among young adults shortly after the warning, explains study senior author Stephen Soumerai, professor of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute.
Shortly before the warning was added, child psychiatrist Dr. Louis Kraus was in Washington, D.C., attending a congressional hearing on the issue. Kraus, who is associate professor and chief of child and adolescent psychiatry at Rush University Medical Center, remembers thinking that with the black box warning, “their well-meaning intentions” could have a devastating effect on the youngest, most vulnerable Americans.
“In regards to the Harvard study, this supports what we’ve been talking about for years,” says Kraus, who was not involved with the study. “There are families that see the black box warning and don’t want their children on drugs, and that has impacted treatment. Not all patients require drugs. Some do. The FDA made this recommendation to protect people. But some children have died as a result.”
The new study found a rise in suicide attempts, but not completed suicides — which are far more rare. Previous research suggested that suicides rose after the warning was issued.
The increase continued until 2010, the last year studied by the researchers. The researchers analyzed data from 1.1 million adolescents, 1.4 million young adults and 5 million adults and used overdose with psychotropic drugs as a conservative measure of suicide attempts.
The effect on suicide attempts is hugely significant for patients, explains Soumerai. “Many people stay in a hospital or treatment facility weeks to months after an attempt, often against their will. … If they had been taking antidepressant drugs, if they’d had their depression controlled, they might have avoided that.”
"The FDA made this recommendation to protect people. But some children have died as a result."
The FDA warning was based on an analysis of all the existing clinical trials at the time and noted that approximately one percent of adolescents and young adults taking antidepressants experienced an increase in thinking about suicide, according to the researchers. The warning mentioned only the potential risk of suicide without noting the potential risk of under-treatment of depression. Later, the FDA did revise the warning to recommend that physicians consider both the risk of prescribing the medication and the risk of not prescribing the medication, monitoring patients for thoughts of suicide and treating them as needed.
In their study, the Harvard researchers found the decline in antidepressant use continued to 2009, then climbed slightly in 2010, but “did not ever go back to where they started,” says Soumerai.
“That’s disconcerting, but when we attribute the effect to the FDA warning and subsequent media coverage, it’s the early years that we are more certain can be attributed to the effect. 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.”
FDA officials said the agency has consistently tried to balance the warning about suicide risk with the reminder that depression itself is a serious illness that raises the risk of suicidal thoughts and actions. There are no plans to remove the warning, FDA spokeswoman Sandy Walsh wrote in an email to NBC News.
"At this time nothing indicates a need for change in the Boxed Warning on these drugs, which urges attention to patients starting treatment, which the FDA feels is still good advice," she said. "The warnings do not suggest avoiding the drugs. The FDA has not tried to discourage the use of antidepressant drugs in people who may benefit from them."
The majority of antidepressant prescriptions for the younger patient population actually don’t come from child psychiatrists, but rather from pediatricians and family practice doctors, for example, says Kraus, citing that there are only about 8,000 child psychiatrists practicing in the United States.
“Until that black box warning there was a progressive decrease of suicides among young people,” he says. “Now, I do think some kids are suffering because they just aren’t getting the right treatments. And for many that’s medication combined with some type of therapy.”