Recently, the UK Committee on Safety of Medicines (CSM) has contraindicated the use of paroxetine to treat depressive illness in children and adolescent under 18 years of age. This recommendation was based on new data from 3 well-controlled clinical trials in children and adolescents. The data did not demonstrate efficacy of paroxetine in depressive illness in this age group and showed an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behaviour in the Seroxat® group compared to placebo. Various analyses suggest that the risk of these outcomes is between 1.5 and 3.2 times greater than Seroxat® compared to placebo. The CSM also advised that paediatric patients who are currently on paroxetine should not have their medication discontinued abruptly because of the risk of withdrawal reactions. The doctors should be consulted to discuss the best course of action.

HSA is currently reviewing the data submitted by the company. Relevant updates reflecting the new data on safety and efficacy in children and adolescents will be reflected in the local package insert.

Paroxetine is approved for use in adults for the treatment of depressive and anxiety disorders. It has been demonstrated to be effective in adults with depressive illnesses. Current evidence does not reveal an increase in the rate of suicidal ideation in adults treated with paroxetine compared to placebo.