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Published on 20 December 2011

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FDA warns pregnant women against antidepressant

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The U.S. Food and Drug Administration (FDA) has delivered a fresh warning that the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy may lead to persistent pulmonary hypertension of the newborn (PPHN).

The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study.

Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.

The FDA reviewed the additional new study results and concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.

The organisation will update the SSRI drug labels to reflect the new data and the conflicting results.

The FDA has advised healthcare professionals not to alter their current clinical practice of treating depression during pregnancy.

FDA



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