Zoloft 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 – including Zoloft (sertraline) – and serious birth defects. Sertraline (marketed as Zoloft) is included in the class of drugs called selective serotonin reuptake inhibitors (SSRIs). This class of drugs is used to treat depression, anxiety, and other mood disorders.

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.

Source: FDA Med Watch Alert