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Advice for women taking paroxetine intending to become pregnant or in early pregnancy

Related information

9 July 2005

There is some information to suggest that use of the medicine paroxetine in early pregnancy (first 13 weeks) may be associated with an increased risk of some congenital malformations in babies. It is not proven that this does occur.

The malformations seen mainly related to the heart and were seen in around 2% of babies born. Heart problems occur in about 1% of all pregnancies.

The vast majority of babies born to mothers who had used paroxetine were healthy babies.

There was a small increase in the incidence of a heart condition called ventricular septal defect, or VSD. VSD is known to occur in babies from time to time, including when mothers have taken no medicines. The condition is often mild and may resolve by itself. In other cases surgery may be required. Your doctor can discuss this condition further with you.

Paroxetine is a medicine that can have withdrawal side effects if stopped suddenly. These could harm you. It is important that you do not stop taking paroxetine suddenly. You should make an appointment to see your doctor and have your treatment reviewed.

Paroxetine is sold under the following brand names in Australia.

Aropax, Oxetine, Paxtine, Chem mart, GenRx and Terry White Chemists paroxetine, Paroxetine-RL, Paroxetine-BC, Paroxetine Hexal, Espar, Loxamine, Paroxat CR and Ausrox.

Content last updated: Saturday, 9 July 2005

Web page last updated: Wednesday, 23 February 2011

URL: http://www.tga.gov.au/safety/alerts-medicine-paroxetine-050907.htm