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ELEANOR HALL: Now to concerns about the prescription of anti-depressants to adolescents, with the American Food and Drug Administration considering whether tighter restrictions should be placed on their use. After examining new evidence suggesting young people taking the anti-depressant Paxil have a higher risk of suicide, the FDA is due to decide next week whether the drug, should be prescribed to people under the age of 18.And the prediction is that the Administration will follow the recent decision by British health authorities to declare that the drug in fact must not be prescribed to young people. And in Australia, the Australian Therapeutic Goods Administration already cautions against the prescription of anti-depressants to children, but it has strengthened its position in the last two months, as Tanya Nolan reports.
TANYA NOLAN: It was the clinical trial conducted by GlaxoSmithKline into its own drug Paxil, or Aropax as it’s known here in Australia, that sparked huge public debate in the UK and recently prompted health authorities there to declare that the drug must not be prescribed to people aged under 18.The company found that a higher risk of self-harm and suicidal thoughts, in at least two per cent of the study group and that there was a similar risk of dependency on the drug. The American Food and Drug Administration has been reviewing that evidence and is considering following Britain’s lead. Professor Jeffrey Lieberman was on the original FDA panel, which formally cleared Paxil of any link to suicide, back in 1991.
JEFFREY LIEBERMAN: Uh, the view now is that this a signal that there may be the potential risk of activating such behaviours in people who are treated with this medication and particularly in young people – adolescents or children.
TANYA NOLAN: So, is that evidence in any way conclusive that there is a link or a causal effect of the prescription of those drugs.
JEFFREY LIEBERMAN: No, no. The evidence at this point is purely associational. Further evaluation needs to be done to determine whether it’s causal.
TANYA NOLAN: Although the evidence is in no way definitive and the FDA, in fact, cautions against young people stopping their medication without professional advice, Professor Lieberman believes there is every likelihood the adverse effects identified in Paxil could be found in other anti-depressants
.JEFFREY LIEBERMAN: It is known that Serotonin is a neurochemical, a neurotransmitter that is involved in regulating emotion and aggression and hostility. And it’s possible since these drugs act on serotonin that they could induce or somehow activate such behaviours. However, if this is the case, it would not be specific to any single SRI (serotonin reuptake inhibitor), but would be the case for all of the drugs that act by the same pharmacologic mechanism of action.
TANYA NOLAN: Up to 80 per cent of teenagers on anti-depressants are prescribed Arapax, here in Australia. The Therapeutic Goods Administration has long warned against the use of anti-depressants by young people, and in recent months, has toughened it stance to state that Arapax should not be prescribed to anyone under 18.GlaxoSmithKline has changed the labelling of its product to include the new warning. However, makers of the other most commonly prescribed anti-depressants say there’s no evidence to suggest any similar risk of suicide amongst young people taking their products. And those prescribing the medicines tend to agree. Doctor Louise Newman is Chair of the Faculty of Adolescent Psychiatry with the Royal College of Psychiatrists, and she says the profession is becoming more adept at diagnosing depression in adolescents and the risks and benefits of medication are carefully weighed up.
LOUISE NEWMAN: There’s evidence that anti-depressants are actually very helpful for that type of depression, so we certainly don’t want to be withholding anti-depressants.
TANYA NOLAN: But Dr Newman says any decision by the FDA will be an important one for Australian psychiatrists.
LOUISE NEWMAN: I think that we obviously need to be guided by the FDA in terms of their monitoring of side effects of all sorts with these sorts of medications. We’re certainly very supportive of that and if there is a ruling that a particular drug shouldn’t be used, then obviously, that would be a very important finding. I think it’s important to recognise that there is a whole range of these drugs. The evidence isn’t clearly there at the moment as to which ones are likely to be more effective. Currently, it’s probably fair to say they all seem to be equally effective in the treatment of depression. But there needs to be an ongoing monitoring of side effect profiles and increasing research looking at the safe use of these drugs, particularly in younger populations.
ELEANOR HALL: Dr Louise Newman from the Royal College of Psychiatrists, with Tanya Nolan.
© 2003 Australian Broadcasting Corporation
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