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FDA Drug Safety Podcast for Healthcare Professionals: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies

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Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today's topic: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies.

LCDR Jennifer Shepherd, a U.S. Public Health Service pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On December 14, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public on the use of SSRI antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn, or 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.

At this time, FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. Healthcare professionals should report any adverse events involving SSRIs to the FDA MedWatch Program.

FDA has reviewed the additional new study results and has 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. FDA will update the SSRI drug labels to reflect the new data and the conflicting results.

PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death.

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. It is unclear whether SSRI use during pregnancy can cause PPHN, because the available data are conflicting.
  2. Healthcare professionals and their patients must weigh the small potential risk of PPHN that may be associated with SSRI use in pregnancy against the substantial risks associated with under-treatment or no treatment of depression during pregnancy.
  3. Untreated depression during pregnancy may lead to poor birth outcomes, including low birth weight, preterm delivery, lower Apgar Scores, poor prenatal care, failure to recognize or report signs of labor; and an increased risk of fetal abuse, neonaticide or maternal suicide.
  4. The published joint 2009 American Psychiatric Association and American College of Obstetrics and Gynecology guidelines for the management of depression during pregnancy includes treatment paradigms for the appropriate management of depression in pregnancy. This article is available through the PubMed Central website at www.ncbi.nlm.nih.gov/pmc.
  5. Adverse events involving SSRIs should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete data summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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