Epidemiological studies have shown a small increased risk of malformations in the cardiovascular system in newborns of mothers who have taken antidepressants containing fluoxetine or paroxetine in the beginning of pregnancy. In addition, the Danish Medicines Agency has received a few reports of the same type of malformations from treatment with citalopram and sertraline.
Physicians are advised to follow the applicable restrictive recommendations and carefully weigh the risks and benefits of using antidepressants during pregnancy and to consider prescribing the medicines in consultation with specialists within the field (psychiatrist and/or obstetrician).
Studies indicate an increased risk of malformations from treatment with fluoxetine and paroxetine
Epidemiological studies indicate that approx. 2 in 100 newborns of mothers who have been treated with fluoxetine or paroxetine have malformations in the cardiovascular system. In general, heart malformations in the cardiovascular system of newborns are relatively common and occur spontaneously in approx. 1 in 100 newborns.
As regards the other medicines of the SSRI type, there are no corresponding, unambiguous and valid results from epidemiological studies of the risk of malformations. However, it cannot be ruled out that the other SSRIs (sertraline, citalopram, escitalopram and fluvoxamine) can also cause heart malformations.
Reports of heart malformations from treatment with citalopram and sertraline
The Danish Medicines Agency has, especially lately, received reports of heart malformations in newborns of mothers who had received treatment with the antidepressants citalopram and sertraline.
However, based on the reported incidents, it is not possible to determine if there is a causal relationship between the mother's treatment with SSRI and the observed malformations, or if the malformations occurred randomly.
Further investigations of the link between the use of SSRI and risk of congenital malformation
The Danish Medicines Agency will investigate further whether there is a possible link between SSRI treatment and the risk of congenital malformation and will submit the case to the European Pharmacovigilance Working Party to obtain experience from the other EU member states.