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Michael Monheit
Michael Monheit
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What Expecting Mothers Must Know – FDA Warnings Issues update on SSRIs

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The FDA has recently issued new safety information about health risks that we posted about back in July: SSRI antidepressant drugs are risky for pregnant women and their unborn children. On December 14, the FDA issued a public safety announcement concerning the link between SSRI drugs and a rare heart and lung condition known as persistent pulmonary hypertension (PPHN)for the newborn.

The first time that the FDA warned about the risks for PPHN in newborns was back in 2006. At the time, there was a study that suggested a risk that taking SSRI medications during pregnancy increased the risk of the child being born with PPHN, a serious and life-threatening lung condition. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream, often necessitate intensive medical care. The study showed that PPHN was six times more common in babies whose mothers took an SSRI medication compared with babies whose mothers took no antidepressant.

Women who seek drug treatment for depression and who are pregnant or are contemplating pregnancy are faced with very difficult treatment choices. And the latest information from the FDA about SSRIs and infant PPHN complicate those choices even more. The FDA now says it has reviewed additional studies and has concluded that “giving the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.”

According to the safety information, two studies suggest an increased risk of PPHN while three other studies find no association between SSRI use and PPHN, concluding that the potential risk remains unknown. Given the low number of studies available and their failure to isolate a causal connection between SSRI use and PPHN, the FDA is saying that the scientific community simply does not know with certainty at this time—one way or the other—what the connection between SSRIs and PPHN is

This is perhaps small comfort to women currently taking SSRIs while pregnant or planning pregnancy. It is even smaller comfort to women who took SSRIs during pregnancy and whose children were born with PPHN. Although the FDA is not advising health care professionals to alter their treatment options, it is advising patients to thoroughly discuss these treatment issues with their doctors. In particular, it is necessary to weigh what the FDA calls the “small potential risk of PPHN” against the “substantial risks associated with under-treatment or no treatment of depression during pregnancy.” Expecting mothers should take this advice to heart; treatment options for depression are highly personal and depend greatly on the specific circumstances of each patient. The best thing a patient can do is educate themselves and discuss and consider all options carefully.