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Worries about safe use of Seroxat by pregnant women

Scientific studies indicate that taking Seroxat when pregnant may increase the chances of birth defects

Photo of pregnant woman by istock

9 August 2009

Legal action is about to commence in the US against GlaxoSmithKline, the manufacturer of Seroxat (paroxetine). Seroxat is one of a class of drugs known as SSRIs (selective serotonin reuptake inhibitors) which are widely used to treat depression.

Several scientific studies have indicated that SSRIs could double the rate of birth defects such as malformed hearts in children whose mothers took the drugs during the early weeks of their pregnancy.

The US Food and Drug Administration, which regulates medicines, issued a warning to doctors in 2005 not to prescribe the drug, known in the US as Paxil, to women who are in the first three months of pregnancy or planning pregnancy, unless other treatment options are not appropriate. However, the US lawyers will argue that GlaxoSmithKline knew or should have known about the link with birth defects more than 10 years ago.

A similar warning was also issued in the UK in 2005 by the Medicines and Healthcare Regulatory Authority (MHRA).

However, experts such as Dr Tim Kendall, the joint director of the National Collaborating Centre for Mental Health which wrote the Nice guidelines on depression, consider that this information may not have filtered through to primary care providers and that SSRIs are most likely still widely prescribed to pregnant women by GPs who may be unaware of the problem.

If you would like to talk to one of our specialist product liability lawyers about this story please contact Jill Paterson on 020 7650 1214 for a free initial consultation.

Information was correct at time of publishing. See terms and conditions for further details.

Information was correct at time of publishing. See terms and conditions for further details.

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