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Paroxetine

Answer

Paroxetine belongs to a class of antidepressant medicines known as the Selective Serotonin Reuptake Inhibitors (SSRIs). At the initial time of licensing, in the absence of human pregnancy data, paroxetine was tested in animal studies in line with regulatory requirements and these did not suggest that paroxetine was teratogenic.In the post marketing period, there have been several epidemiological studies designed to evaluate any possible potential adverse effects in human neonates exposed to paroxetine during pregnancy. The results of the early studies were conflicting and numbers of exposed pregnancies small.More recent studies have suggested that there is the potential for an association between exposure to paroxetine in early pregnancy (the first trimester) and a small increase in the risk of birth defects, in particular heart-related defects. Other studies have shown that exposure to SSRIs, including paroxetine, in the later stages of pregnancy is associated with a small increased risk of a condition affecting the neonatal lung and circulation called Persistent Pulmonary Hypertension of the newborn (PPHN).The product information for-prescribers (the Summary of Product Characteristics) and the patient information leaflet for paroxetine and all SSRIs have been updated to include warnings about the small increased risks of birth defects and PPHN. Information on these risks have also been communicated on the Medicines and Healthcare products regulatory Agency website and through its drug safety bulletin, Drug Safety Update.Current advice is that paroxetine should only be used in pregnancy when strictly indicated and only if the expected benefit to the mother is thought to be greater than any potential risk to the foetus.

Secondary information

Type

Written question

Reference

90540; 539 c73W

Session

2010-12

Related items

Seroxat
Wednesday, 1 February 2012
Written questions
House of Commons

Subjects

Paroxetine

Link

View this Written question on www.publications.parliament.uk