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No Conclusion From FDA on Possible SSRI Antidepressant, PPHN Link

Dec 14, 2011 | Parker Waichman LLP
Pregnant Women

FDA can't Answer the Question Taking SSRI during Pregnancy

The U.S. Food & Drug Administration (FDA) still can't answer the question of whether taking selective serotonin reuptake inhibitor (SSRI) antidepressants  during pregnancy may increase the risk that a baby will be born with pulmonary hypertension of the newborn (PPHN).  In a Drug Safety Communication issued yesterday, the agency said studies on the possible connection between SSRIs and PPHN are conflicting, making it too soon to any conclusions about the risk.

The FDA reviewed a total of five studies as part of its SSRI - PPHN safety review.  Two indicated an increased risk.   The first, published in 2006 in the New England Journal of Medicine, reported a six-fold increase in PPHN among newborn babies whose mothers were exposed to an SSRI after 20 weeks of gestation.   The 2008 study in the journal Pharmacoepidemiol Drug Safety found a statistically significant association between SSRI use and PPHN, though the majority of exposures occurring during the first trimester of pregnancy. However, three additional studies reviewed by the FDA did not report a higher risk of PPHN among children born to mothers who used SSRI antidepressants.

FDA does not Find Sufficient Evidence to Conclude SSRI

"At present, FDA does not find sufficient evidence to conclude that SSRI use in pregnancy causes PPHN, and therefore recommends that health care providers treat depression during pregnancy as clinically appropriate. FDA will update the SSRI labels as any new data regarding SSRI use and PPHN become available," the FDA statement said.

For now, the FDA said it is updating the SSRI drug labels to reflect the new data and the conflicting results.  The agency advised doctors and patients to weigh the possible risk of PPHN against risks associated with under-treatment or no treatment of depression during pregnancy when deciding whether or not use of an SSRI is warranted during pregnancy.

SSRI antidepressants are the most commonly prescribed drug to treat depression in pregnant women.  But as the FDA points out, there are no adequate and well-controlled studies of SSRIs in pregnant women.

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Need Legal Help Regarding FDA's No Conclusion on SSRI and PPHN Link

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