Paroxetine is an SSRI antidepressant used in the treatment of major depressive disorders, anxiety disorders and obsessive-compulsive disorders. New data from Denmark, Sweden and the US represent a potential signal of an increased risk of congenital malformations following maternal use of paroxetine in the first trimester. However, other epidemiological studies have not supported such an increased risk. These new studies suggest that in women taking paroxetine in the first trimester the risk of birth defects in the newborn may increase from 3% to around 4% for all congenital malformations and from 1% to around 2% for congenital heart malformations. However, this type of study (a cohort study), which follows a group of people, isn't as reliable/scientifically robust as another type of study used to test drugs (a randomised controlled trial). This means that the study can't show for certain that paroxetine causes birth defects.

Advice to patients:
• Women taking paroxetine who want to become pregnant are advised to discuss the balance of risks and benefits of continued treatment with their doctor.

• Pregnant women who are currently taking paroxetine should not stop their treatment but should discuss their treatment with their doctor or midwife at their next routine appointment

More information can be found on the Medicines and Healthcare products Regulatory Agency website www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2022698&ssTargetNodeId=221