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Danish report on treatment with SSRI antidepressants

27 September 2011

Based on a debate about the safety of treatment with SSRI antidepressants, the Danish Medicines Agency has drawn up an overview report.

The report aims to provide healthcare professionals and others involved in SSRI treatment with an overview of our current knowledge about the consumption of SSRIs and the safety of this type of medicine.

The main focus of the report is on the safety of SSRIs and the risk of adverse reactions in foetuses and newborns of mothers who have used SSRI antidepressants.

The report's main conclusions about SSRI use during pregnancy

The report's main conclusions are:

  • that SSRIs should only be used during pregnancy after careful considerations by a doctor of benefits and risks for mother and baby.
  • that psychotherapeutic treatment should always be considered as a treatment option for depression in pregnancy, cf. the Danish National Board of Health's guidelines for this area.
  • that medical treatment of depression during pregnancy, including treatment with SSRIs, may be necessary in some cases. For instance, it may be relevant for severe depression or if there is a great risk of recurrence of depression if medical treatment is discontinued. According to the National Board of Health's guidelines, a specialist in psychiatry should be consulted concerning the treatment.

The prescribing doctor faces a difficult deliberation in consultation with the patient. On the one hand, an untreated depression entails some well-known risks. On the other hand, there is a risk of adverse reactions, some of which are documented.

Currently, we know that use of SSRI antidepressants during pregnancy can lead to serious adverse reactions in foetuses and newborns. There is a risk of malformations, including especially malformation of the cardiovascular system, increased pressure in the pulmonary circulation and withdrawal symptoms in the baby. But we also know from extensive scientific studies that the risk is low.

The Danish Medicines Agency will make new knowledge available about the safety of SSRIs on an ongoing basis.