Zoloft (sertraline hydrochloride)

Zoloft has been found to create a much higher risk of birth defects than the manufacturer had been claiming in reports to the FDA.

Sertraline hydrochloride (trade names Zoloft and Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It was introduced to the market by Pfizer in 1991. Sertraline is primarily used to treat major depression in adult outpatients as well as obsessive–compulsive, panic, and social anxiety disorders in both adults and children. In 2007, it was the most prescribed antidepressant on the U.S. retail market, with 29,652,000 prescriptions.

Zoloft linked to numerous birth defects, including heart, abdominal, and cranial defects

The SSRI antidepressant Zoloft has been linked to several types of birth defects in newborns whose mothers were taking Zoloft (sertraline). In many cases, the manufacturer did not fully disclose the actual risk of these injuries to the FDA and doctors and patients, even though the company had such information.

The birth defects associated with Zoloft include: congenital heart defects, particularly atrial ventricular defects (ASD) and ventricular septal defects (VSD).

Other serious conditions linked to Zoloft include: Persistent Pulmonary Hypertension of the Newborn (PPHN); and abdominal congenital defects such as omphalocele (abdominal wall defects); and cranial congenital defects, such as craniosynostosis.

Zoloft (generic name Sertraline) is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. Zoloft/sertraline is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance. (Source: National Institutes of Health)


FDA warns of SSRI (Zoloft, Paxil, etc.) link to persistent pulmonary hypertension in newborns (PPHN)

FDA Public Health Advisory: Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns

… Two new studies provide important information…. The studies included women who had been treated with antidepressant drugs that act as selective serotonin reuptake inhibitors (SSRIs)….

A second study suggests … risks of SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant [such as Zoloft, Paxil, etc.] after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk in one drug compared to another, and this risk has not so far been investigated by other researchers. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.

The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns coming 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. In addition, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiology study suggesting that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects (see FDA Public Health Advisory for Paxil1 dated December 8, 2005).

[The FDA told manufacturers] to change prescribing information to describe the potential risk for PPHN. …

SSRIs and a Combination Drug Containing an SSRI

  • Celexa (citalopram)
  • Fluvoxamine
  • Lexapro (escitalopram)
  • Paxil (paroxetine)
  • Prozac (fluoxetine)
  • Symbyax (olanzapine/fluoxetine)
  • Zoloft (sertraline)

[Source: FDA, 2006]