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Hamish RobertsonHamish Robertson hosts Correspondents Report's weekly look at world issues. Sunday, 8am, ABC Radio National.




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Antidepressants associated with suicide risks

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Correspondents Report - Sunday, 19 September , 2004 

Reporter: Leigh Sales

HAMISH ROBERTSON: Just how safe are anti-depressants?

Well, it's a highly controversial issue, and there's been a good deal of sometimes acrimonious debate among psychiatrists and other mental health professionals.

While most medical specialists seem to agree that anti-depressants, including the widely used Selective Seretonin Reuptake Inhibitors ? or SSRIs ? can be highly effective in the treatment of some forms of depression, recent research has also suggested that their use is not without risk.

Well, in the United States last week, the Food and Drug Administration ordered drug companies to label anti-depressants with a strong warning that they can cause suicidal tendencies in children and teenagers.

The FDA's decision is the strongest stand it could take, other than banning the medication outright for use in children. And it could influence authorities in Australia to impose greater safeguards on the prescription of these drugs here.

Professor David Healy of the University of Wales, is one of Europe's most renowned experts on depression, and he was in Washington last week for the FDA's hearings into anti-depressants.

Our North America Correspondent Leigh Sales asked him to explain the significance of the decision.

DAVID HEALY: What it will mean is that over here in the US, any physician, giving these drugs to children, will actually have to take the issue about the hazards actually into account and parents and children will have to be told about this and they will have to have the opportunity to talk through the issues and be warned as to what things to look out for.

And if that happens, then these drugs can be used much more safely than they have been used hitherto.

LEIGH SALES: Why has the FDA done a back flip on this, because previously it disputed that these drugs were actually dangerous?

DAVID HEALY: It's very hard to know just why the FDA did a back flip, in that in one sense actually the data for this group of drugs? the clinical trials that were done actually for adults years and years ago, gives you just the same figures that we have for kids now.

So really the FDA had just as good a signal that there is an issue here for the last fifteen years as they have now.

LEIGH SALES: Does that mean that could be opening itself up to some sort of legal action?

DAVID HEALY: It's very, very hard to know how these things work. When people begin to look at the issues more closely, when they begin to look at the data that has been there for years and years and years, and when they begin to extrapolate from that as to how many people may have actually lost their lives who wouldn't perhaps have done so if the drugs had had the warning that they could have had years and years ago, I think questions will be asked.

LEIGH SALES: How do you think the drug companies are likely to react to this?

DAVID HEALY: I don't know. They'll have a huge problem in one sense, in that this is a group of drugs that have really come to the end of their patent life and the pharmaceutical companies are at a point soon where they're not going to make that much off them.

So I don't think? they would have reacted much more vigorously if it was a group of drugs early on in their patent life and this is where the companies were going to make their next billions from.

LEIGH SALES: Is this decision likely to influence other countries to impose similar restrictions on the sale and prescription of these drugs?

DAVID HEALY: It's not that they're actually trying to block the use of the drugs, they're just trying to make sure that the drugs get used more safely and they are trying to discourage what one or two have referred to as the cavalier use of these drugs, the use of these drugs for a range of things that they weren't made for.

So from that point of view, the signal that does come from here will have an influence elsewhere. Also, I think it will be heard over with you in Australia and it will also be heard in Europe.

HAMISH ROBERTSON: Professor David Healy, a world renowned authority on depression and the drugs used to treat it. He was talking to our Correspondent in Washington Leigh Sales.
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