Link Between SSRIs and Rare Newborn Condition Still Unclear

Yael Waknine

Disclosures

December 14, 2011

December 14, 2011 — The link between the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and persistent pulmonary hypertension of the newborn (PPHN) remains unclear, says the US Food and Drug Administration (FDA).

In a drug and safety communication released December 14, the agency says it is uncertain whether SSRIs cause PPHN because the data are conflicting.

"Two studies suggest an increased risk for PPHN with SSRI use in pregnancy. Three other studies do not support this association and the potential risk with SSRI use during pregnancy remains unknown," the FDA release notes.

As a result, the agency recommends that pregnant women who are taking antidepressants do not stop treatment.

The update follows an FDA advisory released in July 2006 and reported by Medscape Medical News at that time regarding the potential risk for PPHN associated with gestational exposure to SSRIs.

On the basis of a single study, those data suggested that the continued use of antidepressants past the 20th week of pregnancy was linked to a 6-fold increase in the risk for PPHN, and that discontinuance of antidepressants was associated with a 5-fold increased risk for depression relapse.

At that time, the FDA noted that the potential risk added to growing concerns regarding SSRI safety in pregnancy but that the risk had not been confirmed by other studies.

"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," FDA officials noted in the news release, adding that any conclusions regarding the potential connection are premature.

Clinicians are advised to weigh the small potential risk for PPHN against the substantial risks associated with untreated pregnancy during depression, which may lead to poor outcomes, such as low birth weight, preterm delivery, lower Apgar scores, poor prenatal care, failure to recognize and report signs of labor, and an increased risk for fetal abuse, neonaticide, or maternal suicide.

PPHN, which typically occurs in 1 or 2 per 1,000 births, often involves severe respiratory failure that requires intensive ventilator support to increase oxygen levels. Severe cases can result in multiple organ damage, including brain damage, and even death.

Healthcare professionals are encouraged to report SSRI-related adverse events to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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