The safety of paroxetine (brand name Seroxat) has been under review by the Medicines and Healthcare products Regulatory Agency (MHRA) since first marketing and remains under close review. Paroxetine is licensed in the dose range 10 to 60mg, depending on the indication. The recommended daily dose is 20 mg, with the exception of obsessive compulsive disorder and panic disorder for which the recommended daily dose is 40mg. Clinical experience is that some patients not responding to the recommended dose may benefit from having their dose increased. Prescribers have been advised that in the absence of evidence of a benefit from increasing the dose, good practice would be to maintain patients on the lowest efficacious dose.
Guidance on how to use paroxetine safely and effectively along with information on potential adverse effects is provided in the product information for prescribers, the “Summary of Product Characteristics”, and in the patient information leaflet which accompanies the medicine. These documents are authorised by the MHRA at the time of licensing and updated through the life of the product as new information on potential adverse effects and benefits emerges.
Paroxetine belongs to a class of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs). The safety profile of the SSRIs is a topic which has been the subject of considerable public interest and scientific debate over recent years. In May 2003, in response to continued public concern, the Government established an expert working group to further investigate the safety of SSRIs, with a particular focus on suicidal behaviour and withdrawal reactions. The conclusions and key findings of the expert group were communicated to health professionals on 6 December 2004 and the supporting evidence base was detailed in the Group's comprehensive report entitled “Report of the CSM Expert Working Group on the safety of Selective Serotonin Reuptake Inhibitor Antidepressants” published on the MHRA website at:
www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON1004259
The publication of the Report was timed to coincide with the publication of guidelines on the treatment of depression by the National Institute of Health and Clinical Excellence. Overall it was concluded that SSRIs are effective medicines in the treatment of depression and anxiety conditions, and that the balance of risks and benefits of all SSRIs in adults remains positive in their licensed indications.