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General information concerning use of SSRI antidepressants in pregnant women

Related information

7 September 2005

New information has recently become available that suggests pregnant women who take SSRI antidepressant medicines in early pregnancy may have an increased risk of giving birth to an infant with a heart problem. This association appears to be strongest for the SSRI medicine, paroxetine.

Paroxetine is registered in Australia under the trade names Aropax, Oxetine, Paxtine, Chem mart, GenRx and Terry White Chemists paroxetine, Paroxetine-RL, Paroxetine-BC, Paroxetine Hexal, Espar, Loxamine, Paroxat CR and Ausrox.

Danish study

A recently released Danish study has suggested that pregnant women who take SSRI antidepressant medicines in early pregnancy may have an increased risk of giving birth to an infant with heart problems. In this study, infants exposed to SSRI antidepressants during the first 3 months of pregnancy had a 60% higher chance of having developing a heart problem compared with infants whose mothers did not take SSRI antidepressants.

No information on which individual SSRI medicines were taken is available.

US Study

Early information from another study in the US suggests that the use of the SSRI antidepressant paroxetine may be associated with an increased risk of birth defects, particularly heart problems. In this study, infants of mothers given paroxetine in early pregnancy were 2.2 times more likely to have a birth defect compared with infants of mothers given other antidepressants. They were also 2.08 times more likely to have a heart problem. About 4 in every 100 infants whose mothers were given paroxetine had birth defects and about 2 in every 100 were heart problems. Most of the heart problems were ventricular septal defects (VSD). VSD occur from time to time in women who have taken no medicines. Sometimes they may require surgery but in some cases they get better without any treatment.

Birth defects occur in about 3 in every 100 infants. Heart problems occur in approximately one in every 100 to 200 infants.

In the US study, too few infants were exposed to some antidepressants to determine whether those medications affected the infant during pregnancy. While only paroxetine was statistically significantly associated with these problems information on some other antidepressants was available that suggest use of these other medications would be safer in early pregnancy than use of paroxetine.

Women who are taking paroxetine and are pregnant or are planning to become pregnant should see their doctor to have their treatment reviewed.

It must be emphasised that, even though the risk of malformation was increased, the vast majority of babies of women taking paroxetine in this study were born healthy.

Content last updated: Wednesday, 7 September 2005

Web page last updated: Thursday, 24 February 2011

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