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

for documents that were available on the internet. There are probably documents that are
unpublished and inaccessible, but these are not relevant for our study of information provided to the
public. The study is based on two therapeutic groups, which makes it difficult to generalise to other
drugs, but the problems we identified are also known for other drug groups, as described by
Abraham (7, 27). Another potential limitation of our study is that it is based on documents available
on the internet. Web-pages are changed over time and information is deleted or moved to other
places. However, the identified documents are all dated. Many of the documents about
benzodiazepines might never have been available on the internet, as the internet didn't exist at the
time. This might have contributed to the restricted number of documents that we were able to
identify for the benzodiazepines.
Conclusion
In the light of the precautionary principle and the risk management principle, the results of our
study can be understood in two ways. Seen from a precautionary principle, the drug agencies have
failed to acknowledge that SSRIs can cause dependence, with reference to the diagnostic disease
manuals ICD-10 and DSM-IV, and have prepared conservative estimates with regard to the severity
and the number of people affected. In this perspective, changes in the communication from drug
regulators to the public about adverse effects happened slowly.
Seen from a risk management principle, the drug agencies have reacted in concordance with the
slowly growing knowledge of adverse drug reactions and have sharpened the information to the
public over time. However, relying on spontaneous reporting of adverse effects leads to
underrecognition and delayed information about the problems. In light of the history of other
psychoactive drugs, e.g. benzodiazepines and barbiturates, it is nonetheless surprising that the
regulatory bodies have not required studies from the manufacturers that could elucidate the
dependence potential of the SSRIs before marketing authorization.
Conflicts of interest: None.