Confidential

Not for external distribution

FINAL and APPROVED

 

Seroxat

Reactive Key Messages and Issues Document

 

6 September 2001

 

For further information please contact:

Tim Brown

External Affairs

T: 020 8990 2144

F: 020 8990 4310

 

Addiction

• Seroxat, unlike for example, smoking or alcohol, is not addictive. There are well-defined international criteria for drug dependency and addiction and Seroxat is clearly shown as being neither addictive nor causing dependence.

• Abrupt stopping of any antidepressant can result in a small number of patients experiencing discontinuation symptoms.

• These symptoms - such as dizziness - are generally mild, short-lasting and self-limiting.

• As recommended by the BNF and the EMEA, the likelihood of these symptoms is minimised by gradually tapering the daily dose.

• Seroxat’s high volume of usage compared to other SSRIs means that clinicians may perceive these symptoms occur more frequently with Seroxat. It is important to remember that this is a class effect and can occur with all SSRIs.

The Seroxat SmPC states: In common with other SSRIs, withdrawal symptoms have been reported on stopping treatment. The available evidence does not suggest these are due to dependence. Dizziness, sensory disturbance (eg paraesthesia), anxiety, sleep disturbances (including intense dreams), agitation, tremor, nausea, sweating and confusion have been reported following abrupt discontinuation of ‘Seroxat’. They are usually mild, self-limiting and symptomatic treatment is seldom warranted. No particular patient group appears to be at higher risk of these symptoms; it is therefore advised that when antidepressive treatment is no longer required, gradual discontinuation by dose tapering be carried out.

CLICK HERE TO READ ON