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New data on antidepressants of the SSRI type and prevalence of malformations in newborns

15 March 2012, Updated 16 March 2012

Data from a large Danish registry study launched by the Danish National Board of Health suggest that the risk of malformations in children is slightly increased in women who were treated in early pregnancy with an antidepressant of the type selective serotonin reuptake inhibitors (SSRIs).

The Danish National Board of Health maintains its recommendation that the decision to medically treat depression in pregnant women should be made only in consultation with a specialist in psychiatry and after other non-medical options have been considered.

Review of the safety of SSRIs in pregnant women

The consumption of SSRIs has been on the sharp rise in the past years, which is also the case for the consumption by pregnant women.

Last year, the former Danish Medicines Agency (now the Danish National Board of Health) reviewed the safety of SSRI products when used during pregnancy. The review covered the scientific literature in the area, Danish consumption and adverse reaction data as well as the products' applicable summaries of product characteristics and package leaflets.

The review of earlier studies showed a small increase in the prevalence of malformations in the cardiovascular system in newborns whose mothers had been treated with SSRI products containing paroxetine and fluoxetine in the first trimester. As regards the other medicines in the group of SSRI products (containing sertraline, citalopram, escitalopram and fluvoxamine), the results were not as unambiguous and valid.

Based on the present knowledge, the conclusion was that we could not rule out that the other products also could be associated with an increased prevalence of heart malformations.

Registry study in cooperation with the Danish State Serum Institute

Last year, the former Danish Medicines Agency (now the Danish National Board of Health) initiated yet another registry study to investigate if pregnant women's use of other SSRIs has an impact on the frequency of malformations.

The study was prepared in cooperation with the Danish State Serum Institute and covered approx. 950,000 children, of which approx. 11,000 are children whose mothers had redeemed prescriptions for a medicine of the SSRI type, either at the start of pregnancy or in early pregnancy.

Conclusion of the registry study

The registry study concluded that:

  • There is a slight increase in the prevalence of any type of malformation in children whose mothers redeem prescriptions for a medicine of the SSRI type around the start of pregnancy or in early pregnancy; 3.1 % compared to 2.4 % in other women.
  • It seems that the specific type of SSRI has no impact on this slight increase in prevalence of malformations.
  • There is a slight increase in prevalence for most categories of malformations. Despite the fact that the study comprises nearly 1 million children, it cannot be determined with sufficient certainty if the prevalence of specific malformations is particularly increased.

As the increased prevalence of malformations cannot be uniquely ascribed to a biological effect of SSRI medicines, it is a theoretic possibility that the women who redeem prescriptions for SSRI medicines in some way or other distinguish themselves from other women in areas that may explain the increased prevalence.

The results will be presented to the European Pharmacovigilance Working Party and discussed together with the other knowledge in the area. The new data will also be communicated to physicians and patients in Denmark. Furthermore, it is expected that the study will be published with peer-review in a respected medical journal in mid-2012.

In compliance with the guidelines in the area, the Danish National Board of Health maintains its recommendation that the decision to medically treat depression in pregnant women should be made only in consultation with a specialist in psychiatry and after other non-medical options have been considered.

In the individual case, the potential beneficial and harmful effects of treatment should be weighed against the risks involved for the pregnant woman and unborn child if a depression is not treated adequately.