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1 Selective serotonin reuptake inhibitors (SSRI) – sales, withdrawal ...

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2. Abstract<br />

Psychotropic drug use has increased in all European countries, also in Denmark, due to the<br />

introduction of the so-called selective <strong>serotonin</strong> <strong>reuptake</strong> <strong>inhibitors</strong> (<strong>SSRI</strong>s) in the late 1980s and<br />

changed prescription habits. Further, patients have raised the suspicion that the <strong>SSRI</strong>s could cause<br />

dependence. This suspicion has, however been rejected by marketing authorisation holders and by<br />

regulatory agencies, the latter being responsible for guarding public safety in relation to medicines<br />

The overall aim of this PhD thesis was to explore the life-cycle of the <strong>SSRI</strong>s and compare it with<br />

benzodiazepines with respect to use and dependence. This was investigated in 3 studies. In the first<br />

study, we explored the possible causes for the <strong>sales</strong> of psychotropic medicines in Denmark. In the<br />

second study we explored the rationale for claiming that benzodiazepines cause dependence while<br />

selective <strong>serotonin</strong> <strong>reuptake</strong> <strong>inhibitors</strong> (<strong>SSRI</strong>s) do not. The third study was a documentary study<br />

describing actions and statements of the regulatory agencies in UK, USA, England and Denmark.<br />

We explored the communications from drug agencies to the public saying that benzodiazepines<br />

cause dependence whereas selective <strong>serotonin</strong> <strong>reuptake</strong> <strong>inhibitors</strong> (<strong>SSRI</strong>s) cause a <strong>withdrawal</strong><br />

syndrome because the phraseology of the communications might explain why benzodiazepines are<br />

viewed as being addictive in contrast to <strong>SSRI</strong>s.<br />

The first study showed that the <strong>sales</strong> of psychotropic drugs has fluctuated widely over a 37-year<br />

period. We believe that the decline in <strong>sales</strong> of benzodiazepines was primarily due to the recognition<br />

that they cause serious dependency and by initiatives at a national level to curb their use, and that<br />

the recent steep increase in <strong>sales</strong> of <strong>SSRI</strong>s is a direct consequence of marketing pressures, as the<br />

effect of the <strong>SSRI</strong>s is overestimated.<br />

The second study showed the <strong>withdrawal</strong> reactions to <strong>SSRI</strong>s were very similar to those for<br />

benzodiazepines. It therefore makes no sense to describe only the latter as dependence symptoms.<br />

denied that the reactions indicated <strong>SSRI</strong> dependence. Drug regulators underestimated in both cases<br />

the frequency and severity of the symptoms. The third study showed that in the perspective of the<br />

precautionary principle it could be understood as if the drug agencies have refused to acknowledge<br />

that <strong>SSRI</strong>s can cause dependence, with reference to the diagnostic disease manuals ICD-10 and<br />

DSM-IV, and minimised the problem with regard to the severity and the number of people affected.<br />

5

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