Paroxetine Safety in Pregnancy

December 29, 2005 at 9:46 am | In Prescribing Extra - Drugs |

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:

paroxetine should only be used in pregnancy where strictly indicated and where the benefits outweigh the risks
until further investigations are conducted, paroxetine may not be the most suitable selective serotonin reuptake inhibitor (SSRI) in women who are or plan on becoming pregnant
if the decision is made to stop paroxetine, this should be done gradually over a period of several weeks

The MHRA also have the following advice for patients:

women taking paroxetine who are planning a pregnancy should consult their doctor to discuss treatment options
pregnant women currently taking paroxetine should not stop treatment abruptly but should discuss their treatment at their next routine appointment with their doctor or midwife

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.