Notice type: 3rd Party Publications

Date: 31/08/2005


Product name or type:
Paroxetine- MIMS Advisory

Prescription Required:

Problem Or Issue:


Paroxetine belongs to the class of antidepressants collectively known as selective serotonin re-uptake inhibitors (SSRIs). Concerns regarding the safety of SSRIs, including paroxetine, have been continuously reviewed and evaluated by the IMB, together with its expert committees and EU counterparts, with regulatory action taken as necessary and information provided to healthcare professionals on an on-going basis, as new data have become available. 

A formal European-wide re-evaluation of the overall benefit-risk profile of paroxetine-containing medicines was initiated in June 2003 following a Referral to the Committee for Human Medicinal Products (CHMP). This referral was requested on the basis of on-going safety concerns relating to the potential for psychiatric disorders (including self-harm, suicidal thoughts, attempted suicide and hostility) and withdrawal reactions associated with the use of paroxetine. The CHMP issued its Opinion on 8 December 2004, concluding that the benefit-risk balance for paroxetine-containing products remains positive across the approved indications in adults, but recommended a number of changes to the product information. 

The European Commission recently accepted the recommendations from the CHMP and the associated changes to the product information for paroxetine, outlined below, which are currently being implemented. 

Revised Product Information 

Changes to the product information include the following: 
• A warning to remind prescribers that paroxetine should not be used in children and adolescents. Data from controlled clinical trials in paediatric patients have shown paroxetine to be associated with an increased risk of adverse events associated with suicidal behaviour and hostility, and that efficacy has not been adequately demonstrated. 
• Strengthened disease related warnings, recommending close monitoring of patients at high risk of suicidal behaviour. These include patients with a known history of suicidal behaviour or suicidal thoughts prior to starting treatment and young adults. 
• Strengthened warnings regarding withdrawal symptoms, indicating that withdrawal symptoms upon stopping treatment are common, particularly if discontinuation is abrupt, and that patients must not stop their treatment abruptly except on medical advice. Generally, withdrawal symptoms are mild to moderate and self-limiting, however in some patients they may be severe and/or prolonged. 
• Strengthened warnings regarding a risk of serotonin syndrome, akathisia, gastrointestinal bleeding and hyponatraemia. 
• Additional information regarding use during pregnancy and lactation relating to potential neonatal complications. 

In addition, the indications for use of paroxetine in adults were harmonised across all EU Member States and include treatment of depression and anxiety disorders (obsessive-compulsive disorder, generalised anxiety disorder, post traumatic stress disorder, panic disorder and social anxiety disorder).

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