- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Paroxetine Safety in Pregnancy

The Summary of Product Characteristics for Paroxetine (Seroxat) has been updated to include an additional warning against using this drug in the first trimester of pregnancy.

This new information has been reported to clinicians in a letter from the manufacturers and is also the subject of a Medicines and Healthcare products Regulatory Agency (MHRA) Safety Warning.

This new information has come to light following a retrospective epidemiological study of birth defects in infants born to mothers who took antidepressants during the first trimester of pregnancy. The results of the study are available online in the GSK Clinical Trial Register.

The MHRA advise clinicians that:

The MHRA also have the following advice for patients:

Action: Clinicians will need to be aware of this latest advice. It may also be beneficial to ensure that midwives working with your surgery are aware of this advice and the implications.