Published on April 15th, 2012, an important letter to the editor of American Family Physician was sent by Dr. Brian Budenholzer that cautioned against Paxil use during pregnancy. (Accordingly, his piece was titled “Paroxetine Use Should Be Avoided During Pregnancy”.) As it is relatively short, I have chosen to include it in its entirety below.
“To The Editor: In the FPIN’s Clinical Inquiries on which antidepressants are safe to use during pregnancy, Dr. Patel and colleagues suggest that paroxetine (Paxil) is safe. Although they note that the American College of Obstetricians and Gynecologists recommends avoiding paroxetine use during pregnancy, they do not provide the evidence supporting the recommendation. Paroxetine actually carries a category D rating from the U.S. Food and Drug Administration (FDA) for safety in pregnancy.
Two studies have found an association between first trimester paroxetine use and congenital malformations, notably cardiac malformations. The first study, completed in 2005, showed “a trend towards a 1.5-fold increased risk for cardiovascular malformations for paroxetine compared to other antidepressants. This study also showed a statistically significant increased overall risk of major congenital malformations (inclusive of the cardiovascular defects) in infants exposed to paroxetine compared to other antidepressants.”1
In the second study, an analysis of data from the Swedish Medical Birth Register revealed an association between use of paroxetine and cardiovascular congenital defects, most notably ventricular and atrial septal defects.2 On the basis of these two studies and at the FDA’s request, GlaxoSmithKline downgraded their rating of paroxetine safety in pregnancy to category D.3
When this information is added to the data presented by the authors, I believe the evidence supports avoiding paroxetine use during pregnancy, especially in the first trimester. Physicians should also consider this evidence when counseling women of childbearing age about medication choices for depression.
BRIAN BUDENHOLZER, MD
Due to the fact that the manufacturers of Paxil have time and again failed to warn users of the risk for congenital anomalies, a number of Paxil® birth defect lawsuits have been filed.
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