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FDA Unwilling to Declare Link Between Antidepressants and Birth Defect

A study from 2006 suggested that there could be a link between antidepressants and a severe birth defect. But subsequent studies have had mixed results, and this has caused the FDA to avoid telling pregnant women to stop using these antidepressants, despite the fact that some of the later studies have shown an increased risk.

The class of drugs known as SSRIs (selective serotonin reuptake inhibitors) includes such popular antidepressants as Celexa, Luvox, Lexapro, Paxil, Prozac, and Zoloft. In the 2006 study, use of these antidepressants beyond the fifth month of pregnancy was shown to increase the risk by six times of the child having a respiratory problem known as PPHN.

PPHN, (persistent pulmonary hypertension) in newborns causes breathing problems which often require the baby to be on a ventilator to ensure proper oxygen levels. Without immediate care, organ damage can occur-including brain damage and death.

Since the 2006 study, five other studies have looked at the same issue, with differing results. The FDA pointed out that each of the five studies was designed differently, and had different methods for collecting information about exposure to the drugs. Two of the subsequent studies did find a link between PPHN and use of the antidepressants, and one in particular showed that the exposure came during the first trimester of pregnancy-a somewhat different finding than the original 2006 study, but still troubling.

Although the FDA has not definitively said there is a link, these drugs do carry a warning reading "Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN)." The FDA suggests that any decisions regarding the use of antidepressants by pregnant women should be made carefully.

The FDA must weigh the benefits of antidepressants with the risks of the birth defect on a national scale involving tens of thousands of women. But for individual patients, their decision whether or not to take drugs of this kind is not so general-and the wrong choice could have very specific consequences. If you or someone you know is pregnant and taking antidepressants, consult with a doctor regarding the risks. And if a child has been born with PPHN to a mother taking SSRIs, talk to an experienced medical malpractice lawyer.

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