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Antidepressants in pregnancy: absolute rates of harm would have improved risk message

BOSTON — In 2006, the FDA warned the public that the use of common antidepressants, like Prozac and Paxil, late in pregnancy could put a baby at risk for respiratory failure. Many women with depression faced a difficult decision: continue their medication during pregnancy, potentially putting their child at risk, or jeopardize their own mental health by going off the drugs.

The FDA advisory pointed to a single study showing a six-fold increased risk of a condition called persistent pulmonary hypertension in newborns whose mothers were taking antidepressants.

But now a new, large-scale study finds that the risk is negligible — much lower than previously believed, reports CBS Boston’s Dr. Mallika Marshall.

Researchers at Brigham and Women’s Hospital in Boston looked at 3.8 million pregnant women nationwide and found that those taking popular antidepressants, called SSRIs, did not appear to be at significantly increased risk of having a baby with pulmonary hypertension.

“The risk increase of taking antidepressants late in pregnancy, if present, is much more modest than previous studies have found,” says Krista Huybrechts, Ph.D., an epidemiologist at Brigham and Women’s Hospital. “So for women with severe debilitating depression that is not responsive to other non-pharmacological treatments, this should be reassuring information.”

It’s certainly reassuring news for Dr. Katherine Economy, a maternal fetal medicine specialist at the Brigham who cares for many pregnant women on antidepressants.

“They take them because they have a disease that impacts their daily life,” Economy says. “And for many women, they cannot get through their daily activities, getting out of bed, taking a shower, and preparing food for themselves. So for many of these women, these medications are life-saving and life-altering.”

Dr. Economy warns patients about the potential risks like withdrawal in the newborn and a small risk of heart defects, but says for many women, the worst time to stop their medications is at the end of pregnancy when postpartum depression becomes a concern.

“My basic message is that, overall, there may be some slight risks associated with the medication, but in balancing risks and benefits for most women, I would suggest they stay on their medication,” she said.

Antidepressants in pregnancy pose little risk to babies, study finds

Our Review Summary

This story covers a new study that partially uproots a concern that doctors and pregnant women alike have faced since before 2006: taking certain antidepressants during pregnancy. Called selective serotonin reuptake inhibitors, or SSRIs, these drugs can alleviate common symptoms of depression that some pregnant women may grapple with. The text story and accompanying video touch on the quality of evidence (i.e. a huge sample size of millions of women), and the story appropriately highlights the slight risks to newborns in pregnant women who take SSRIs. Commentary from an expert not involved with the study adds important context to the coverage. The story could have done a better job of explaining the FDA’s concerns about a “six-fold increase” in risk to newborns and showing the actual rates observed in the new study. More information on the harms of not taking SSRIs, as well as potential alternatives to SSRIs, would also have been welcome. A HealthDay story on the same study provided more of the information that we were looking for.


Why This Matters

It’s widely known that many women grapple with depression following the birth of a child. According to the American Psychological Association, between 9 and 16 percent of women experience postpartum depression (PPD). What’s more, women who’ve experienced PPD and have a second pregnancy might have a 2-in-5 chance of having PPD again. But what’s less widely known or accepted, says the CDC, is that depression among pregnant women is about 8 percent.

Antidepressant drugs like Prozac and Paxil offer a potential treatment option for depression in pregnancy, but in 2006 the FDA warned such drugs could increase the likelihood of two major problems with newborns: a life-threatening lung condition called persistent pulmonary hypertension of the newborn, or PPHN. If this is incorrect, as the recent Journal of the American Medical Association study indicates – and by a wide margin of risk – it could be a boon to women who struggle with depression during pregnancy. It’s potentially also good news for the babies, because there are risks to the baby of untreated depression in the mother.


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Costs aren’t mentioned. These costs for these medications vary widely depending on the SSRI, the manufacturer (i.e. brand-name vs. generic), and dosage – between $20 and $1,000 a month, according to Consumer Reports.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The benefits are described in broad strokes but never really quantified. We’re told the FDA, back in 2006, said taking SSRI antidepressants late in pregnancy might increase the rate of PPHN six-fold – but we’re never told what the absolute rates are. Mentioning a few numbers from the study would have made this story’s look at the benefits more informative.

For example, of the 3.8 million women looked at in the study, about 102,000 took SSRI antidepressants. The rate of PPHN for that group was about 31 cases per 10,000 births, compared to 20.8 cases per 10,000 births in women who didn’t take SSRIs. The HealthDay story again did this nicely — it helps to have the overall rate of PPHN, the rate in depressed women not taking anti-depressants, and the rate on non-SSRI anti-depressants for comparison. These figures reinforce the finding that PPHN is uncommon overall, and that the risk in women who take SSRIs is not much higher than in those who don’t.

Does the story adequately explain/quantify the harms of the intervention?


The harms mentioned by this story include PPHN, newborn withdrawal from antidepressants, and “a small risk of heart defects.” This is responsible – and enough for a Satisfactory rating. The story could have gone further by quantifying these harms and mentioning the potential harms of untreated depression, which aren’t noted in the story. As noted by the study author in the competing HealthDay story: “Untreated depression or anxiety during pregnancies has been linked to different adverse health outcomes, such as miscarriage, preterm birth, pre-eclampsia and smaller newborns,” Huybrechts said.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story recognizes the value of a large population, i.e. 3.8 million women, but doesn’t otherwise comment on the quality of the evidence. This was a very strong study, but not without limitations. For example, while the study accounted for a variety of potential confounding factors, the researchers noted that “information on some potential confounding factors is incomplete (eg, smoking) or absent (eg, maternal body mass index, diabetes severity), which may have resulted in residual confounding …” The story could have provided a blanket caution about the limits of observational studies to cover this concern, or used this concern as a jumping-off point for a brief discussion of the study’s many strengths.

Does the story commit disease-mongering?


We didn’t see any distracting statements or portrayals in this story that exaggerate PPHN, its nature, or its prevalence. And that could have been easy to do, since stories about dying children can be particularly harrowing. If anything, this is an anti-scaremongering story, and quotes from experts go a long way in tempering worries.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

We didn’t find one of the sources quoted in the story — Dr. Katherine Economy — on the list of study authors, nor in the acknowledgements, which suggests she wasn’t involved in the study. But as the story points out, she works at the same institution as several of the authors and could therefore be less objective than some other independent observers. Her comments are certainly valuable and add important perspective to the piece. But to be consistent with our standard, we are obligated to rule this Not Satisfactory. We feel that it’s always a good idea to reach an outside source for comment.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Two choices are presented in this story for pregnant women who suffer from depression: take SSRIs or don’t. But that leaves out a third possible choice, mentioned in the study, which is to take a non-SSRI antidepressant. The story could have earned a Satisfactory by mentioning that alternative, or at least providing more information about the complications pregnant women might face if they’re depressed and not taking an antidepressant.

Does the story establish the availability of the treatment/test/product/procedure?


We’re told this study applies to “common” antidepressants, and a few widely known prescription name brands are mentioned. The availability (through diagnosis and a medical professional’s prescription) isn’t overtly established, but it’s implied.

Does the story establish the true novelty of the approach?


The story establishes what is novel here: a large new study shows that the risk associated with antidepressants is much lower than previously believed based on a 2006 study.

Does the story appear to rely solely or largely on a news release?


It’s clear some original reporting was done and that the story did not rely excessively on a JAMA news release. That release did have some useful information (e.g. roughly how many pregnant women take SSRIs, the mortality rate of PPHN, confounding factors, etc.).

Total Score: 5 of 10 Satisfactory


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