Written question asked by Eric Ollerenshaw (Conservative) on Wednesday, 25 January 2012, in the House of Commons. It was due for an answer on Monday, 30 January 2012. It was answered by Simon Burns (Conservative) on Wednesday, 1 February 2012 on behalf of the Department of Health.

Seroxat

Question: To ask the Secretary of State for Health pursuant to the answer of 23 January 2012, Official Report, column 73W, on paroxetine, if he will quantify the magnitude of the small increased risks identified in the circumstances described in the Answer.

Answer: Observational studies suggest about two in 100 babies whose mothers take paroxetine in early pregnancy are born with a birth defect, in particular a heart-related defect. This compares with about one in 100 babies born to women who have not taken paroxetine. For an individual woman, the magnitude of the risk following exposure to paroxetine in the first trimester of pregnancy is difficult to estimate because several risk factors exist for birth defects, including smoking and other dietary and lifestyle factors.For persistent pulmonary hypertension of the newborn (PPHN), observational studies suggest that about five in 1,000 babies born to mothers who have taken an antidepressant of the same type as paroxetine (selective serotonin reuptake inhibitors or SSRIs), particularly in late pregnancy, develop this condition. This compares to about one to two cases of PPHN in 1,000 babies born to women not exposed to SSRIs during pregnancy.Any increase in risk to the foetus due to paroxetine is small and needs to be considered in the context of the potentially greater risk that may result from the mother's untreated depression. The product information for paroxetine, including the patient information leaflet, outlines these small risks to support discussion between health care professionals and patients.

Secondary information

Type: Written question
Reference: 92574; 539 c681W
Session: 2010-12
Related items: Paroxetine
Monday, 23 January 2012
Written questions
House of Commons
Subjects: Paroxetine
Link: View this Written question on www.publications.parliament.uk