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

Results
We identified 6 documents related to the benzodiazepines and 23 documents for the SSRIs (table 2).
All documents are official ones and convey drug regulators’ and other health authorities' positions,
i.e. they express one-way communication and are authoritative. A public and media focus on the
SSRI withdrawal syndrome initiated a review process, during which working groups were
established in drug agencies that referred to each other in the documents. References are shown in
table 2.
Time to recognise adverse effects
Two papers from the Committee on Safety of Medicines (UK) from 1980 and 1988, an article from
the Committee in 1993, and minutes from the Committee in 2004 (see table 2) showed that it took
more than eight years for the UK regulators to accept the frequency and seriousness of the
dependence potential of benzodiazepines, and ten years to accept withdrawal reactions as a class
effect of SSRIs and that the symptoms can be serious.
In both cases, the source of the assessments was the spontaneous reporting system for adverse drug
reactions, as shown in a systematic review by the Committee on the Review of Medicines (1980)
and an article by Price et al. (1996).
Increasing frequency and seriousness of dependence and withdrawal reactions
The frequency and seriousness of the reactions related to benzodiazepines increased in the
assessments over time. In 1980, the estimate of people suffering from benzodiazepine dependence
was low, only 28 persons in the UK (Committee on the Review of Medicines, 1980), but in 1988,
the risk of dependence was becoming “increasingly worrying” (Medicines Control Agency). From
1980, restricted use of benzodiazepines was recommended from 1980 (Committee on the Review of
Medicines, 1980), i.e. short-term use, doses within the therapeutic range and gradual withdrawal.
From the meeting minutes in the UK Medical Research Council, an estimate of the frequency of
dependence appears low, but because many people used benzodiazepines, the number of dependent
people was assessed to be around 10,000 – 100,000 people in UK (Medical Research Council
Headquarters file 1980-82).