Antidepressants and Birth Defects

In July 2006, the U.S. Food and Drug Administration (FDA) notified healthcare professionals and consumers of a possible link between antidepressant medications and serious birth defects. The study, published in February 2006 in The New England Journal of Medicine, included pregnant women who were treated with SSRIs, or in a few cases, other antidepressant medications. SSRI medications are the most commonly used drugs to treat depression in the U.S.

The study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream.

In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.

Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects. Most of the cardiac defects observed in the Paxil studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart does not completely developed.

Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN.

To learn more about antidepressants and birth defects watch “SSRI Antidepressants Increase Risk of Birth Defects”.

Source: FDA Med Watch Alert