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Volume 448: debated on Thursday 29 June 2006

To ask the Secretary of State for Northern Ireland what assessment he has made of the safety of Seroxat for pregnant women suffering from depression; and if he will make a statement. (80110)

On 7 December 2005 the Chief Medical Officer issued an urgent communication to the Health and Social Services in Northern Ireland attaching a letter from the Commission on Human Medicines (CHM) which highlighted new evidence relating to a possible risk of congenital malformations following maternal use of Paroxetine (Seroxat) in the first trimester. The CHM letter contained advice to prescribers and patients on the use of Paroxetine (Seroxat) in pregnancy. The advice indicated that Paroxetine should only be used in pregnancy when strictly indicated and only if the benefits of treatment for the mother are thought to outweigh the potential risk to the foetus.

There is ongoing discussion at a European level on the safety of all selective serotonin reuptake inhibitors (SSRIs), including Paroxetine (Seroxat) in pregnancy. Any new advice will be issued as necessary.