Pregnancy Antidepressants: Baby Risk
Deadly Newborn Lung Ailment Linked to Late-Pregnancy Depression Drugs
Feb. 8, 2006 -- Babies whose mothers took antidepressant drugs in the second half of pregnancy are six times more likely to have a rare but dangerous lung ailment, a new study suggests.
One study isn't proof. But it's strong evidence that taking SSRI antidepressants -- such as Prozac, Zoloft, and Paxil -- carries an extra risk during pregnancy.
The risk is that the babies will have PPHN: persistent pulmonary hypertension of the newborn. Only one or two in a thousand babies get this, but it's very serious. It kills about one in 10 babies who get it. In moderately severe cases, half the survivors suffer hearing loss or brain damage.
"We find these results very concerning," Sandra L. Kweder, MD, deputy director of the FDA's office of new drugs, said in an unusual, hastily called news conference. "We find the reported association of SSRI antidepressants with this very serious condition to be very worrisome."
This does not mean that pregnant women with clinical depression should forgo treatment, says researcher Christina Chambers, PhD, MPH, of the University of California, San Diego. Chambers is program director of the California Teratogen Information Service. CTIS conducts pregnancy outcomes research and offers women information about the pregnancy risks of drugs and chemicals.
"This is a fairly low risk for women taking SSRI antidepressants," Chambers tells WebMD. "So if in fact SSRIs cause PPHN, the risk appears to be low. For 100 women taking one of these medications late in pregnancy, only one may have a child with PPHN."
"This isn't a cause for panic among pregnant women taking these medicines," the FDA's Kweder says. "This is the kind of information a woman should discuss with her doctors -- not just her obstetricians but also the doctor providing her mental health care. Stopping these medicines on your own can create more problems than it solves. The small risk that is being reported here may well be outweighed by your need for a medicine to treat your depression."
The study appears in the Feb. 9 issue of The New England Journal of Medicine.
Kweder says the FDA is taking a hard look at Chambers' findings. She says the FDA will issue a public-health advisory in the next few days.
"We are in the process of evaluating the Chambers article further," Kweder explains. "We will look at our Adverse Event Reporting System and other databases to see if we have any data to add to this."
Kweder says the FDA may ask antidepressant makers to add a warning to their labels. The agency may also ask the companies to conduct new surveys of pregnant women who use or have used their products, she notes.
The Risk of SSRIs to the Newborn
In an earlier study of pregnancy outcomes, Chambers saw two cases of PPHN. Since there were relatively few women in the study, it was an unexpected finding. Both mothers, it turned out, had taken Prozac late in their pregnancies.