10 September 2011
Fluoxetine (brand names Prozac and Oxactin) is a selective serotonin reuptake inhibitor (SSRI) medicine commonly used to treat depression.
Depression occurs in many populations, including 7-20% of pregnant women. It is important to treat this condition, as untreated depression in pregnancy can lead to clinical problems for both the mother and the newborn baby. Around 2% of pregnant women use SSRIs.
The SSRI paroxetine has been shown to be associated with a small increased risk of heart defects in the unborn child if used during the first three months of pregnancy (see MHRA safety warning, December 2005).
Evidence from published clinical studies suggests that fluoxetine may also be associated with this risk, therefore all data on this issue was analysed. The results and conclusions of the analysis are summarised in this Public Assessment Report.
The naturally occurring incidence of heart defects in an unborn child is approximately 1 per 100 pregnancies. The analysis suggested that the use of fluoxetine in early pregnancy may slightly increase this risk to around 2 per 100 pregnancies. This is similar to the level of risk with paroxetine.
This report presents the evidence that was available when the regulatory decision was made, showing a ‘snapshot’ of the clinical landscape at the time. However, any advice in this report remains current unless it is superseded by a more recent report (where relevant, this is indicated).