FDA Considers Fresh Warning on Antidepressants The Food and Drug Administration already requires warning labels on a class of antidepressant drugs known as SSRIs. The labels warn that the drugs could increase the risk of suicidal thoughts in pediatric patients. Now the agency is considering a similar warning for adults.
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FDA Considers Fresh Warning on Antidepressants

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FDA Considers Fresh Warning on Antidepressants

FDA Considers Fresh Warning on Antidepressants

FDA Considers Fresh Warning on Antidepressants

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The Food and Drug Administration already requires warning labels on a class of antidepressant drugs known as SSRIs. The labels warn that the drugs could increase the risk of suicidal thoughts in pediatric patients. Now the agency is considering a similar warning for adults.

RENEE MONTAGNE, host:

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

We know depression can cause suicide, but can antidepressants do the same thing? Today the Food and Drug Administration is taking up one of the toughest questions facing the agency, whether certain types of anti-depressants known as SSRIs are dangerous.

NPR's Joanne Silberner reports that a panel convened by the FDA may have a hard time making a recommendation on what to do about this class of popular drugs, which includes Zoloft, Prozac and Paxil.

JOANNE SILBERNER: At previous hearings, distraught parents told of the suicides of their children who had taken these drugs. Other parents said the drugs saved their children. In response to all the evidence collected, in 2004 the FDA required warning labels saying that adolescents and children taking the pills might be more likely to consider suicide. But the evidence for adults is less consistent, so the FDA has convened an advisory committee to consider it all.

FDA staffers have supplied panelists with an analysis of 372 studies involving more than 100,000 patients. The analysis didn't turn up conclusive evidence that the drugs made suicide more likely, but it does show some people taking the pills may be more likely to think about suicide.

David Fassler is a clinical professor of psychiatry at the University of Vermont. He studied the report.

Professor DAVID FASSLER (Psychiatry, University of Vermont): When you break down the age ranges it looks like the young adults are more similar to the children and adolescents, and you may actually have an increase in spontaneous reports. And older people in the geriatric population, it's actually the opposite.

SILBERNER: Fewer thoughts about suicide. So the association seems to be uneven and difficult to explain and only some of the conclusions are statistically significant. But there are critics outside the FDA who look at other data and see a definite trend.

Psychiatrist David Healy of the University of Cardiff in Wales is one of them. He points to an analysis by the British version of the FDA that showed suicide incidents more than doubled. He doesn't trust the FDA analysis.

Dr. DAVID HEALY (Psychiatrist, University of Cardiff, Wales): We can be reasonably confident that they didn't even then have all of the trials that have been done by all of the different firms that actually make drugs in this area.

SILBERNER: An FDA spokesperson says the agency did look at every relevant study. The question today isn't even about suicide itself; it's about whether the drugs make people think about suicide.

Healy says he'd be happy if the FDA decides to tell people the drugs could prompt suicidal thoughts and they should be watched carefully by their doctors and loved ones for signs of distress.

Prof. HEALY: We can actually make the use of the drugs much more safer if we just put reasonable warnings on them; if we give both the physicians who hand out the drugs and the people who may actually have to have the drugs warnings that the drugs may not suit them.

SILBERNER: But others say people who desperately need the drugs could be scared off. The FDA warning about suicidal thinking in young people sent prescriptions down 25 percent, says David Fassler, and he says that could increase the suicide rate.

Prof. FASSLER: I'm very worried that there are kids and potentially adults who have serious mental illness, who have depression, who aren't getting the effective and appropriate treatment that they need and deserve.

SILBERNER: But David Healy disagrees. He says doctors know that all drugs have some risks and they'll just prescribe the drugs to people who really need them.

Prof. HEALY: There are grounds to think that it would be a good idea if people thought just a bit more about do we need to use to use these drugs so that they don't hand them out quite as freely as they have done.

SILBERNER: One thing both men agree on - none of the studies so far question patients the way you'd really need to to measure suicidal thinking. The National Institute of Mental Health recently announced the start of five studies that will do it right, but results from those studies could be years in coming.

Joanne Silberner, NPR News, Washington.

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