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April 16, 2002

Death of a Dream

The spectre of addiction could burst the Prozac bubble

THE world's love affair with the antidepressant drug Prozac could end in

tears, according to a report written independently by a member of the WHO's

Advisory Panel on Drug Policies and Management. Medawar says that

the side effects of Prozac and its relatives have been underestimated, the

drugs may be addictive and they are not as effective as was first hoped.

Prozac is the best known of several drugs called selective serotonin

re-uptake inhibitors, which treat depression by boosting levels of the

neurotransmitter serotonin in nerve synapses. SSRIs have been on sale in

Britain for 10 years. In that time they have racked up 17 845 official

reports of adverse effects from GPs.

Ralph , director of the WHO's Collaborative Centre for International

Drug Monitoring in Uppsala, Sweden, says: " I don't always agree with

Medawar's interpretations, but there's something strange going on with a

drug when you have a huge number of side effects reported but little done

about it. "

Medawar says that, like benzodiazepine drugs such as Valium and Mogadon,

SSRI antidepressants can cause dependence. He says doctors mistake symptoms

caused by the drugs' withdrawal for signs of relapse.

The extent of benzodiazepine addiction was only discovered when doctors

realised that the drugs' withdrawal symptoms-insomnia, tension and

depression-were identical to those they were supposed to treat. Yet a review

of safety data by Medawar reveals that since 1963, 230 million prescriptions

of the two main benzodiazepine drugs temazepam and diazepam in Britain have

generated just 25 official notifications of withdrawal reactions. In under

10 years, 5 million prescriptions of an SSRI called paroxetine generated 802

notifications.

Malcolm Lader, professor of psychopharmacology at the Institute of

Psychiatry in London, is cautious about Medawar's conclusions: " I think he

takes the comparison between benzodiazepines and SSRIs too far. Withdrawal

symptoms and dependence are not necessarily the same thing. "

Lader says that patients have not been shown to crave SSRIs when they are

withdrawn. " But I agree with him that the efficacy of SSRIs has been

disappointing, " he says. Medawar cites two studies, each of which looked at

more than 60 trials. " These showed that SSRIs do have the edge on

alternatives, but not by much. "

Both studies used the number of patients who gave up taking the drugs as an

indicator of efficacy. The first study found that 5 per cent fewer patients

on SSRIs dropped out of the trials compared with those taking alternatives,

while the second study showed a difference of only 3 per cent.

Medawar's report is published in The International Journal of Risk and

Safety in Medicine(vol 10, p 75).

Day

The Avenging Angel

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Please report all adverse drug reactions to:

http://www.fda.gov/medwatch/index.html

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April 16, 2002