FDA Unable to Clarify Link Between SSRI Antidepressants, PPHN

The U.S. Food & Drug Administration (FDA) has been unable to conclude whether or not the use of selective serotonin reuptake inhibitor (SSRI) antidepressants during pregnancy increases the risk that a baby will be born with persistent pulmonary hypertension of the newborn (PPHN). In a Drug Safety Communication issued yesterday, the FDA advised doctors and patients to weigh the possible risk of PPHN against risks associated with untreated depression during pregnancy when deciding whether or not use of an SSRI is warranted for an expectant mother.

According to the FDA, SSRI antidepressants, which include Celexa (citalopram); Lexapro (escitalopram); Luvox and Luvox CR (fluvoxamine); Paxil, Paxil CR, and Pexeva (paroxetine); Prozac, Sarafem, and Symbyax (fluoxetine); Viibryd (vilazodone) and Zoloft (sertraline), are among the most commonly prescribed drugs to treat depression during pregnancy. However, there are no adequate and well-controlled studies of SSRIs in pregnant women.

In 2006, the “Usage in Pregnancy” section on the labels for SRRI antidepressants was updated with the following warning: “Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN).” The labels were modified after a study published 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.

According to the Drug Safety Communication issued yesterday, a 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. The results of the 2008 and 2006 studies have been interpreted by some to show a strong association between SSRI use in pregnancy and the development of PPHN, according to the FDA. However, the agency’s review of medical literature also revealed three studies that did not find an increased risk of PPHN.

Because of these conflicting results, the FDA said it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. However, the agency said it will update the SSRI drug labels to reflect the new data and the conflicting results.

PPHN, which occurs in roughly 1 or 2 newborns per 1,000 births, is a disorder which affects the lungs in which the arteries are severely restricted. This causes blood pressure in the pulmonary artery of the heart to rise to excessive levels, leaving the baby unable to 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.

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