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Study Finds No Heart Defect Risk from Antidepressants


June 19, 2014 — A study published in the New England Journal of Medicine has found reassuring evidence that heart defects are not more common in infants who are exposed to antidepressants during the first three months of pregnancy.

Conclusions were based on data from nearly one million women who gave birth between 2000-2007. About 64,000 of them (6.8%) used an antidepressant medication during the first trimester. Researchers compared the rate of heart defects among infants born to women who used antidepressants vs. those who were not exposed.

Heart defects occurred in 6,403 infants who were not exposed to an antidepressant (72 out of 10,000) compared to 580 infants who were exposed (90 out of 10,000). These raw numbers suggest a 25% increased risk of heart defects from antidepressants.

However, when researchers restricted the analysis to control for risk-factors, they were left with just 217,343 women. After eliminating women who drank alcohol, smoked, and used other psychotropic medications, the increased rate of heart defects dropped to 12%.

After controlling for risk-factors like diabetes, high blood pressure, severe depression, and more, antidepressants were associated with a 6% increased risk of heart defects — and that number was small enough to be caused by chance.

This led the researchers to conclude that antidepressants do not increase the risk of having a baby with a birth defect. It is reassuring for women who are struggling to decide whether the risk of relapsing into depression is worth the potential risk to their baby.

In 2005, the U.S. Food and Drug Administration (FDA) warned that two epidemiological studies linked the use of Paxil (paroxetine) during the first trimester to an increased risk of heart defects. Numerous other studies have found similar associations from Zoloft (sertraline). Drug-makers are now facing over 500 lawsuits alleging that they did not sufficiently warn pregnant women about the potential risk of birth defects.


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