FDA Debates Warning Labels for Anti-Depressants
ALEX CHADWICK, host:
From the studios of NPR West, this is DAY TO DAY. I'm Alex Chadwick.
MADELEINE BRAND, host:
And I'm Madeleine Brand.
Coming up on the program one more Democrat is headed to Capitol Hill defeating an incumbent Republican in the last undecided race of the midterm elections.
CHADWICK: First, a debate over anti-depressants prescribed to tens of millions of Americans. These drugs are the subject of a meeting today in a hotel ballroom in the suburbs of Washington, D.C.
This is a meeting that's becoming contentious and emotional.
BRAND: Two years ago the Food and Drug Administration decided to make manufacturers of these drugs - and we're talking about drugs like Paxil, Zoloft, and Prozac, the manufacturers had to include a label warning that these drugs can make children and adolescents think about suicide.
CHADWICK: And the question today before a panel of experts now assembled by the FDA should these labels also apply to adults.
NPR's Joanne Silberner has been in that hotel ballroom today. She joins us now. Joanne, welcome back to the program. And this panel of experts, what sort of recommendations are they considering here?
JOANNE SILBERNER: Well, the FDA wants to know what they think about extending that warning not just for children and adolescents but to young adults up to age 25. They want to know whether the panel thinks it's a good idea to also add that it actually looks good for people over 65. It does - these drugs seem to have a protective effect against suicidal thinking and maybe even for people 30 to 65, but over 65 is very clear.
And they want to add to the label that you really need to watch people, especially in the beginning, when you put them on one of these drugs.
CHADWICK: What strikes me is what they are saying here is that different ages apparently have quite different reactions or at least somewhat different reactions to the same drug by a different age group.
SILBERNER: Yeah, and no one's really been able to explain that. I mean sometimes different drugs have different effects in younger people versus older people because their metabolisms are different. But this one doesn't seem to explain itself away that way.
One of the theories about how these drugs can make people think about suicide or at least admit to it is that when you're severely depressed you may not admit to it or you may not be thinking about much.
But as - if the drugs are working as they're working it could be that they energize people a little bit. And then they may think about suicide a little more where they weren't thinking about anything before.
CHADWICK: So there have been a lot of studies on this. I know just from reading a little bit of news reporting on it, I mean, a lot of data for these panelists to consider.
SILBERNER: Right. And none of the data are good. I mean that's the problem. They look at the synopses of these 372 studies. None of the studies did what you would really want a study about suicide to do which is ask people very specific questions and a series of questions to make sure that their answers are consistent.
These studies were all about other things, you know, were they back to their activities of daily living, for example. So a lot of these suicides or suicidal thoughts were just, you know, what people admitted to on their own and what the doctors happened to write down. It's not a concerted effort.
CHADWICK: Joanne, you've been in many of these FDA hearings over the years. But I gather this one's a little different because members of the public are testifying as well, not just experts.
SILBERNER: Well that happens sometimes but never as emotional as this. I mean there is nothing like the grievance of a parent who's lost a child from a drug that the parent encouraged the child to take. Or, you know, a woman who lost her husband after they had triplets and he was depressed about that. He took the drug and killed himself.
I mean the level of emotion is enormous. And other people are in there are coming back and saying that no, they had depression, they took the drugs, and that's why they're here today. But I can tell you it's less compelling than hearing about a parent who lost a child.
CHADWICK: NPR's Joanne Silberner listening to the FDA hearings in Silver Spring, Maryland. Joanne, thanks.
SILBERNER: Thank you.
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