Q1 What is paroxetine?

A1 Paroxetine is a selective Serotonin Re-uptake Inhibitor (an SSRI) medicine. It affects the transmission of chemical messages in the brain and nervous system. It is used to treat conditions such as depression, obsessive compulsive disorder, panic disorder with or without agoraphobia, social anxiety disorder (social phobia), generalised anxiety disorder and post-traumatic stress disorder.

Q2 What is the safety concern?

A2 The marketing authorisation holder for Seroxat (paroxetine) has provided regulatory authorities with further information from an epidemiological study (non-experimental studies based on analysis of situations when they have occurred). Additionally data from the Swedish Birth Registry became available. Both studies have suggested a small increased risk of cardiovascular birth defects (e.g. ventricular septum defects VSD (majority) and atrial septum defects ASD, a condition where the partition of the heart chambers is damaged) associated with use of paroxetine by the mother in the first 3 months of pregnancy.

Q3 Is this information relevant for other SSRIs?

A3 The main information is derived from studies with paroxetine and there is only limited information available for the other individual SSRIs.

Q4 What are the consequences of this new information?

A4 In October 2005, the product information for paroxetine was changed to include a warning of a possible small increase in the risk of congenital (i.e. present from birth) defects (e.g. VSD) related to the use of paroxetine during the first trimester of pregnancy. The results of the above mentioned studies suggest that the risk of having an infant with a cardiovascular defect (e.g. ventricular septum defects VSD (majority) and atrial septum defects ASD) following maternal paroxetine exposure is less than 2/100 compared with an expected rate for such defects of approximately 1/100 in the general population.

However, data from these studies did not show a clear signal of an increased risk for overall congenital malformations .

Consequently, the product information SPC and package leaflet for paroxetine has again been updated to reflect this new information.

Q5 Should paroxetine no longer be prescribed to women who want to become pregnant or are already pregnant?

A5 As was always the case, paroxetine should only be used by women who are pregnant when strictly indicated. The prescribing physician will consider the option of alternative treatments for women who are pregnant, or are planning to become pregnant. It is also advised to carefully observe the newborn child immediately after birth (during the first 24 hours) due to possible withdrawal symptoms, especially when paroxetine has been used by the mother in the last 3 months of the pregnancy.

Q6I am currently taking paroxetine and would like to become pregnant. What should I do?

A6 If you would like or are planning to become pregnant, do no stop using the medicine but contact your doctor. Your doctor will evaluate with you if it is important for you to continue to take paroxetine.

Q7 I am currently taking paroxetine and am pregnant. What should I do?

A7 If you are concerned you should see your doctor and together you should decide whether it is important for you to continue to take paroxetine. If it is agreed that you should stop treatment with paroxetine, it is important not to cease treatment abruptly but to reduce the dose gradually over a period of weeks. Abrupt cessation can cause withdrawal symptoms, which can be severe in some patients (for example dizziness, changes in feelings, sleeping disorders).

However, it must also be emphasised that, even though the research signals there may be a low level increase in the risk of congenital malformations, these were of a common type that may spontaneously occur and even reverse after birth. In addition, the majority of babies of women taking paroxetine in the study were born healthy.