Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants Drug Safety Communication

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Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication – Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn

 

Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone) 

AUDIENCE: Psychiatry, OB/GYN, Family Practice

ISSUE: FDA notified healthcare professionals and 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  P ersistent 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.

BACKGROUND: SSRIs are marketed under various brand and generic drug names, and are used to treat depression and other psychiatric disorders. There are no adequate and well-controlled studies of SSRIs in pregnant women.

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.

RECOMMENDATION: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. See the Data Summary in the FDA Drug Safety Communication for additional information.
 
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm283696.htm

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