Increased Risk Of PPHN When Women Use SSRIs Medications Like Celexa, Lexapro, Paxil, Prozac, And Zoloft After Their 20th Week Of Pregnancy
A recent medical journal article, "Prenatal exposure to antidepressants and persistent pulmonary hypertension of the newborn: systematic review and meta-analysis", published by BMJ in January 2014, brought more attention to a serious but often overlooked drug risk presented by some popular antidepressant drugs like Celexa, Lexapro, Paxil, Prozac, and Zoloft. These prescription medications are in the Selective Serotonin Reuptake Inhibitors, or SSRIs, class of drugs.
From the Abstract for that January 2014 BMJ article:
- Objective To examine the risk for persistent pulmonary hypertension of the newborn associated with antenatal exposure to antidepressants.
- Conclusions The risk of persistent pulmonary hypertension of the newborn seems to be increased for infants exposed to SSRIs in late pregnancy, independent of the potential moderator variables examined. A significant relation for exposure to SSRIs in early pregnancy was not evident. Although the statistical association was significant, clinically the absolute risk of persistent pulmonary hypertension of the newborn remained low even in the context of late exposure to SSRIs.
This important finding, however, is not new.
Back in 2006 The New England Journal of Medicine (NEJM) published this article, "Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn", about a study which had results that were similar to those from the 2014 BMJ article, above.
The Abstract for the 2006 NEJM provides this information:
- BACKGROUND: Persistent pulmonary hypertension of the newborn (PPHN) is associated with substantial infant mortality and morbidity. A previous cohort study suggested a possible association between maternal use of the selective serotonin-reuptake inhibitor (SSRI) fluoxetine late in the third trimester of pregnancy and the risk of PPHN in the infant. We performed a case-control study to assess whether PPHN is associated with exposure to SSRIs during late pregnancy.
- RESULTS: Fourteen infants with PPHN had been exposed to an SSRI after the completion of the 20th week of gestation,.... In contrast, neither the use of SSRIs before the 20th week of gestation nor the use of non-SSRI antidepressant drugs at any time during pregnancy was associated with an increased risk of PPHN.
- CONCLUSIONS: These data support an association between the maternal use of SSRIs in late pregnancy and PPHN in the offspring; further study of this association is warranted....
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Soon after the above NEJM article about the SSRIs - persistent pulmonary hypertension (PPHN) birth defect problem was published Health Canada issued a drug safety alert, as we reported in this March 2006 post, "Health Canada Issues Pregnancy Warning For Antidepressants -- Newborns Whose Mothers Took SSRIs At Increased Risk Of Serious Lung Disorder":
On March 10, 2006 Health Canada issued a warning for women taking antidepressant drugs known as Selective Serotonin Re-uptake Inhibitors (SSRIs) -- including Prozac and Paxil -- and who are pregnant or thinking of becoming pregnant.
Health Canada issued this advisory to draw attention to a recent study published in The New England Journal of Medicine which linked Prozac, Paxil, and other drugs in the SSRI class to a rare but potentially fatal condition in newborns called persistent pulmonary hypertension. According to the advisory, cases of persistent pulmonary hypertension have been reported in babies born to women who took SSRI antidepressants during the second half of their pregnancies.
While the FDA has looked at this drug safety problem for some years, now, unfortunately the agency has not reached any definitive conclusions and certainly has not taken the necessary actions to prevent future cases of PPHN caused by antidepressants / SSRIs like Celexa, Lexapro, Paxil, Prozac, and Zoloft, despite the severity of this birth defect condition.
From this December 2011 document, "FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies":
The U.S. Food and Drug Administration (FDA) is updating the public on the use of selective serotonin reuptake inhibitor (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 (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....
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. (See Data Summary).
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....
And, likewise, the drug companies responsible for these widely used antidepressants have apparently not taken the obvious steps to heighten awareness of the SSRI - PPHN drug safety issue by getting Prozac, for example, moved to Pregnancy Category D (Prescription drugs which are known to impose health risks for the fetus) -- as Prozac was still included in Pregnancy Category C when I last looked at its Prescribing Information, or drug label (accessed 1/16/14).
For more on the meanings of those FDA categories, see this background article (albeit we posted it back in 2005): "The Safety of Prescription Drugs During Pregnancy -- FDA Uses Five Pregnancy Risk Categories At Present".
Of course, we will continue to watch for and report any significant developments concerning this serious drug safety issue, whether those are on the medical, pharmaceutical, and/or regulatory fronts.