Pregnant women taking selective serotonin reuptake inhibitors for depression may continue to do so, despite a 2006 warning that the drugs may predispose infants to persistent pulmonary hypertension, the Food and Drug Administration announced Dec. 14.
That earlier warning was based on a single study indicating that infants exposed to the drug in utero after the 20th week of pregnancy were six times more likely to develop persistent pulmonary hypertension (PPHN) than nonexposed infants (N. Engl. J. Med. 2006;354:579-87).
"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 persistent pulmonary hypertension," the FDA said in a press statement.
The agency will update the drugs’ warning labels to reflect data from new studies, which have produced conflicting results about the risk SSRIs may pose to an unborn child.
Physicians and their patients should carefully weigh the risks and benefits of any antidepressant use in pregnancy, the FDA added, given that there are "substantial risks associated with undertreatment or no treatment of depression during pregnancy."
Those studies include a large retrospective database study in 2009 that found no association between SSRI use and PPHN (Pharmacoepidemiol. Drug Saf. 2009;18:246-52), and a 2011 case-control study of 11,923 births that showed PPHN was associated with cesarean delivery but not with SSRI use in the second half of pregnancy (Am. J. Perinatol. 2011;28:19-24).
FDA officials concluded that the evidence is not sufficient to withhold SSRI treatment from pregnant women or take them off the antidepressants. "At present, FDA ... recommends that health care providers treat depression during pregnancy as clinically appropriate," according to the agency’s statement.
Physicians and their patients should carefully weigh the risks and benefits of any antidepressant use in pregnancy, the FDA added, given that there are "substantial risks associated with undertreatment or no treatment of depression during pregnancy."
Risks of untreated maternal depression can include low birth weight, preterm delivery, lower Apgar scores, poor prenatal care, failure to recognize or report impending labor, and increased risks of fetal abuse, neonaticide, or maternal suicide, the FDA warned.
Both the American Psychiatric Association and the American College of Obstetricians and Gynecologists recommend monitoring pregnant women for depression and treating them appropriately.
Physicians should continue to report any possible adverse effects to the FDA’s MedWatch program. Reporting forms can also be requested by calling 800-332-1088. The form can be submitted online or by fax to 800-FDA-0178.