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

Introduction
Today it is well documented that benzodiazepines can cause dependence, but for many years it was
only discussed and not widely accepted. It also took some years before it was recognised that
SSRIS can cause withdrawal reactions but today it is well described. It is well described that
antidepressants and other psychotropic drugs may cause withdrawal reactions (1, 2). In 1961,
Hollister, Motzenbecker & Degan (3) documented dependence with benzodiazepines. However,
when benzodiazepines were first launched, the drug companies claimed that they did not have such
effects (4). It is still being discussed whether SSRIs can also cause dependence.
Drug agencies play a very important role for reliable information about drugs. They are responsible
for informing about efficacy and adverse effects of drugs, which is a prerequisite for informed
consent when doctors prescribe drugs for patients. Society has an expectation that drug agencies
will offer neutral and comprehensive information, also after marketing authorization is granted.
Pharmacovigilance systems update information about adverse reactions, which may lead to
regulatory action or changes in the information to prescribers and the public (5). Two different
models of drug regulation are described. The first is the precautionary principle model and the
second the risk management principle model (6). The precautionary principle has its focus on safety
and effectiveness and accurate information to the public and prescribers. Even in absence of firm
data about adverse events, signals should lead to delayed market authorization or restrictions. The
risk management principle focuses on facilitating the industry’s possibilities to develop new drugs
and market them quickly. The risk management principle holds that drugs should be assumed safe
unless there is information to the contrary (6). These two paradigms are obviously in conflict, and
the risk management principle has often been criticized. Abraham (7) suggested that drug regulation
is permissive, Lader (8) talked about conservative drug regulation, and McGoye (9) described drug
regulators' 'will to ignorance' in relation to safety issues.