FDA Says Link Between SSRIs and Rare Newborn Disease Is Unproven
It's premature to reach any conclusion about a possible link between SSRI use in pregnancy and a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN), according to the Food and Drug Administration (FDA). In a “Safety Communication” released yesterday, FDA said it has reviewed data and concluded that given the conflicting results from different studies, it is premature to reach a conclusion about a link between SSRI use in pregnancy and PPHN. FDA will update SSRI drug labels to reflect the new data and the conflicting results. An initial Public Health Advisory in July 2006 on this possible risk was based on a single published study, and since then, there have been conflicting findings from studies evaluating this potential risk. Based on its data review, FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. The FDA Safety Communication is posted at www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm283696.htm. To read coverage of this issue in Psychiatric News, click here.
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