For more information or confidential assistance
Call 800-306-3180

Research Review Shows Paxil Birth Defect Risk

woman holding pregnant bellyThe use of Paxil (paroxetine) by pregnant women during their first trimester has again been linked to birth defects in their children, according to a recent review of previous scholarly studies on the subject.

Although the antidepressant is considered relatively safe, it nevertheless comes with a warning on its label concerning potential heart defect risks to babies born to mothers taking the drug during pregnancy. Getting a clearer look at possible risks of birth defects may help doctors assess which patients to treat with medications such as Paxil (a serotonin reuptake inhibitor or SSRI), and which patients might be safer with alternative treatments.

In order to gain a better understanding of the Paxil birth defect risks, the team (led by Anick Berard of CHU Sainte-Justine and the University of Montreal) took a look at 23 previous studies published between 1966 and 2015. The metaanalysis suggests a 23 percent rise in serious congenital birth defects and a 28 percent rise in heart defects among babies whose mothers took Paxil during their first trimester of pregnancy. The research team posted their findings in the British Journal of Clinical Pharmacology.

Assessing Paxil birth defect risks

Previous studies had suggested a correlation between Paxil use during pregnancy and an increase in birth defect rates and the latest study seems to confirm this correlation. However, researchers and other scholars provide a number of caveats.

First, despite the increased risk apparently associated with Paxil, the overall risk of a child developing birth defects remains low (between 1 to 3 percent).

Second, they note that some of the data was not as comprehensive as they would have liked. In some of the studies considered, the number of birth defects identified was extremely small.

In addition, the study does not demonstrate a clear causal relationship between the use of Paxil (and other SSRI antidepressants) and birth defects. It is possible that depression itself is the factor resulting in the birth defects in that certain behaviors associated with serious depression (such as malnutrition or missing doctor’s visits) can result in low birth weight babies and other problems.

The study also did not include data on the severity of depression or whether women had other depression-related health problems that resulted in more birth defects.

When antidepressants are warranted

Doctors treating pregnant women for depression have to weigh the relative risks of SSRI use vs. leaving the depression untreated or inadequately treated. Because of the potential for increased birth defect risks, some doctors avoid giving the medications to such women unless absolutely necessary, an evaluation tied to the severity of the depression from which the women suffer.

Dr. Berard notes that milder forms of depression can often be treated successfully with therapy or other non-pharmaceutical options.

However, the risks associated with untreated depression in women suffering from severe cases of the condition may be greater to both mother and child than those of potential SSRI side effects.

Malnutrition and lack or medical care may put both mother and child in harms way. In the most extreme cases, the risk of suicide can also rise significantly. Doctors in these cases must make the best informed decisions possible, with a full awareness of the relative risks associated with SSRI use or non-use.

  1. Foxnews, Paroxetine in Early Pregnancy Once Again Linked to Birth Defects

  2. FDA, FDA Advising of Risk of Birth Defects with Paxil, Agency Requiring Updated Product Labeling