Potential risks of in utero exposure

USA. The FDA has received reports of adverse events (AEs) in neonates exposed in utero to SSRIs and serotonin and noradrenaline reuptake inhibitors (SNRIs), including agitation, irritability and feeding difficulties, possibly symptoms of a withdrawal syndrome. A US FDA advisory committee has recommended that the potential risks of in utero SSRI-exposure should be described in patient labelling. The proposed precaution states that "neonates exposed to SSRI/SNRI late in 3rd trimester have developed AE requiring prolonged hospitalization, respiratory support, tube feeding. AE may arise immediately upon delivery". The FDA is also proposing class labelling of SSRIs and SNRIs on in utero exposure to be added to the pregnancy section.

Reference:

Reactions Weekly (Adis International), No. 1007, 26 June 2004.