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SSRI Link To PPHN Unclear, FDA Says | cialis online

SSRI Link To PPHN Unclear, FDA Says

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The SSRI link to PPHN remains unclear, according to the U.S. Food & Drug Administration (FDA), which just issued an update to the public concerning the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by expectant mothers. At issue is the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN).

The FDA’s initial Public Health Advisory issued in July 2006 on this potential risk was based on one published study; however, since, there have been conflicting findings from new studies evaluating the risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN. At this time, the agency is advising health care professionals not to alter their current clinical practice of treating depression during pregnancy. Healthcare professionals and patients should report any adverse events involving SSRIs to the FDA MedWatch Program, the agency said.

The FDA reviewed the additional new study results and said that, given the conflicting results from different studies, a conclusion about a potential link between SSRI use in pregnancy and PPHN would be premature. The FDA plans to update SSRI drug labels to reflect the new data and the conflicting results. SSRIs include Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, and Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); and Viibryd (vilazodone).

SSRIs operate by raising levels of serotonin, which plays a role in the development of the fetus, explained NewsInferno.

PPHN affects between 1 and 2 infants per 1000 live births in the general population; PPHN, although rare, is associated with significant infant morbidity and mortality as well as long term health issues. A 2006 study found a six-fold increase in PPHN among newborns whose mothers were exposed to an SSRI after 20 weeks of pregnancy and a more recent study found a statistically significant association between SSRI use and PPHN, although most SSRI exposure took place during the first trimester of pregnancy.

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

Women who are pregnant or planning to become pregnant are advised to speak with their physicians, if they are depressed or being treated for depression, about appropriate treatment options and the benefits and risks of taking an SSRI during pregnancy. Patients should never stop taking an SSRI without first speaking with their physician as suddenly stopping SSRI treatment can cause a depression relapse and other adverse side effects.

The FDA notes that 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; an increased risk of fetal abuse; and neonaticide or maternal suicide.

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