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

There are different views whether SSRIs can cause dependence or not (10,11), and such controversy
was also seen with the benzodiazepines (12). According to Peter Haddad (13), most medical
authorities in the early 2000s do not think antidepressants could cause dependence, even though the
European Medicines Agency (EMA) in 2000 (14) concluded that there was a lack of adequate
studies and even though three SSRIs in 2002 were among the 30 highest-ranking drugs for which
dependence has ever been reported to the Uppsala Monitoring Centre database (15). In 2012, we
showed that the discontinuation symptoms of benzodiazepines and SSRIs are very similar (16).
This suggests that both drug groups can cause dependence.
A few years after the introduction of SSRIs, concern was raised that they could cause dependence.
This was confused, however, with a discussion about relapse of the disease, as withdrawal reactions
are difficult to recognise and may be misinterpreted as incipient relapse (17). In the USA,
paroxetine was marketed directly to consumers as “non-habit forming” (18).
It is therefore interesting to examine how drug agencies act when there is controversy. We studied
how drug agencies communicated information about withdrawal reactions for benzodiazepines and
SSRIs.
Aims
Our aim was to explore how changes in the adverse reaction profiles of benzodiazepines and SSRIs
with respect to dependence and withdrawal reactions were reflected in the communications from
drug agencies and other relevant health authorities to the prescribers and the public over time.
Further, we evaluated the communications in light of the two models of drug regulation, based on a
precautionary principle and a risk management principle (6).
Methods
Our study was based on documentary sources produced mainly by drug agencies as part of their
regulatory tasks, including minutes from meetings, published articles, reports and other documents.
We searched the web-sites of the drug agencies in USA (Food and Drug Agency, FDA), UK
(Medicines Control Agency/Medicines and Healthcare Products Regulatory Agency, MCA/MHPR),
Europe (European Medicines Agency, EMA) and Denmark (Danish Medicines Agency, DKMA)
for documents mentioning benzodiazepines or SSRIs in order to study any trends in statements