Shots - Health News
2:34 pm
Wed June 18, 2014

Warnings Against Antidepressants For Teens May Have Backfired

Originally published on Fri June 20, 2014 5:24 am

Government warnings that antidepressants may be risky for adolescents, and the ensuing media coverage, appear to have caused an increase in suicide attempts among young people, researchers reported Wednesday.

A study involving the health records of more than 7 million people between 2000 and 2010 found a sharp drop in antidepressant use among adolescents and young people and a significant increase in suicide attempts after the Food and Drug Administration issued its warnings.

"This was a huge worldwide event in terms of the mass media," says Stephen Soumerai of the Harvard Medical School, a co-author of the study, which was published in the journal BMJ. "Many of the media reports actually emphasized an exaggeration of the warnings."

Starting in 2003, the FDA warned that popular antidepressants, such as Prozac, Zoloft and Paxil, might increase the risk that kids would think about killing themselves — or even actively attempt it.

In fact, no one knew for sure if the drugs were really dangerous. The idea was to get doctors and parents to keep a closer eye on kids taking them just in case it was true.

"The warnings were well-intentioned but people were concerned that the ferocity of the messages might affect clinicians, parents and young people in a way that would reduce needed medications," Soumerai says.

Antidepressant use nationally fell 31 percent among adolescents and 24 percent among young adults, the researchers reported. Suicide attempts increased by almost 22 percent among adolescents and 33 percent among young adults, they said.

But some other researchers questioned the report's conclusions.

"I don't think one can interpret the findings the way the authors interpret the findings," says Michael Schoenbaum of the National Institute of Mental Health.

For one thing, there could be other explanations for why antidepressant use fell. And Soumerai's team based its conclusion that suicide attempts increased on the fact that drug overdoses rose.

"I think it's questionable [that] the data they are using to measure suicide attempts are actually reflecting suicide attempts at all," Schoenbaum says, noting that the drug overdoses may actually have been accidental rather than intentional.

But Soumerai and his colleagues dispute those criticisms. And other scientists say the findings are consistent with what earlier research had suggested.

"I think there were a lot of mistakes made in terms of how this risk was communicated to the public, which led a lot of parents to be terrified to have their children on these medications — and they took them off and there was a lot of untreated, serious depression," says Robert Gibbons, a University of Chicago biostatistician who advised the FDA on the issue.

Soumerai and his colleagues say their findings show the FDA needs to do a better job of explaining warnings about drugs.

"Given the hazards of undertreatment of depression that we believe occurred here, we feel that there is a need for communications by the FDA to be coordinated better to avoid exaggerated messages to the public," Soumerai says.

In an emailed statement, the FDA defended its warnings. "The FDA saw an important risk signal with antidepressants and we put that information in the drug labels," the agency said, noting that it never intended to discourage giving kids antidepressants and making it clear that depression is a serious illness that needs to be treated.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.

Transcript

RENEE MONTAGNE, HOST:

This is MORNING EDITION from NPR News. Good morning. I'm Renee Montagne.

LINDA WERTHEIMER, HOST:

And I'm Linda Wertheimer. New research has reignited a debate about how best to treat depressed teenagers. A major Harvard study concludes government warnings that antidepressants might be risky for teens are backfiring. It finds the warnings could actually be causing more young people to try to kill themselves. But as NPR's Rob Stein reports, that remains the center of intense controversy.

ROB STEIN, BYLINE: This is the story of good intentions possibly gone bad. In 2003, the FDA started issuing warnings about antidepressants like Prozac, Zoloft, Paxil, saying that they might actually increase the risk kids might think about or even try to commit suicide.

STEPHEN SOUMERAI: This was a huge, worldwide event in terms of the mass media.

STEIN: Stephen Soumerai at Harvard Medical School's been studying what happened as a result.

SOUMERAI: Many of the media reports actually emphasized an exaggeration of the warnings.

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED ANNOUNCER 1: What if your child suddenly became suicidal or violent?

UNIDENTIFIED ANNOUNCER 2: All antidepressants carry black box warnings that they increase the risk of...

UNIDENTIFIED ANNOUNCER 3: ...Suicidal thoughts and behavior among children.

UNIDENTIFIED ANNOUNCER 4: ...Medicine would increase the likelihood of homicide or suicide.

STEIN: In fact, no one knew for sure if the drugs were really dangerous. The idea was to get doctors and parents to keep a closer eye on kids taking them, just in case it was true.

SOUMERAI: The warnings were well-intentioned, but people were concerned that the ferocity of the messages might affect clinicians, parents and young people in a way that would reduce needed medications.

STEIN: And in new research being published in the British medical journal BMJ, Soumerai and his colleagues conclude that's exactly what happened.

SOUMERAI: This incredible attention caused an overreaction by everybody involved.

STEIN: Soumerai and his colleagues studied medical records from more than 7 million people and concluded that antidepressant use among teenagers, and even young adults, plummeted after the warnings came out. And, they say, lots more kids and even young adults tried to kill themselves.

SOUMERAI: Among adolescents, suicide attempts increased by almost 22 percent. Young adults, suicide attempts increased by about 33 percent.

STEIN: Big numbers. But others say Soumerai's team hasn't made its case. Michael Schoenbaum is with the National Institute of Mental Health.

MICHAEL SCHOENBAUM: I don't think one can interpret the findings the way the authors interpret the findings.

STEIN: For one thing, there could be different explanations for why antidepressant use fell. For another, there's big questions about whether suicide attempts really went up. Soumerai's team based its conclusion on the fact that drug overdoses rose.

SCHOENBAUM: I think it's questionable whether the data they are using to measure suicide attempts are actually reflecting suicide attempts at all.

STEIN: They may actually be accidental overdoses, not attempted suicides, he says. But Soumerai and his colleagues dispute those criticisms. And other researchers, like Robert Gibbons at the University of Chicago, say the new study is consistent with what earlier research has suggested.

ROBERT GIBBONS: I think that there were a lot of mistakes made in terms of how this risk was communicated to the public, which led a lot of parents to be terrified to have their children on these medications. And they took them off, and there was a lot of untreated, serious depression.

STEIN: Soumerai and his colleagues say their findings show the FDA needs to do a better job explaining warnings about drugs.

SOUMERAI: We feel that there is a need for communications by the FDA to be coordinated better to avoid exaggerated messages to the public.

STEIN: The FDA sent NPR a statement defending its warnings, saying the agency never intended to discourage giving kids antidepressants and made it clear that depression is a serious illness that needs to be treated. Rob Stein, NPR News. Transcript provided by NPR, Copyright NPR.