Antidepressants, Pregnancy & Birth Defects

Antidepressants and pregnancy may be a hazardous combination, warns the Oxford Journal on Human Reproduction.  The 2012 report examined the risks of selective serotonin reuptake inhibitor (SSRI) use in infertile women, and how the drugs impact fertility, pregnancy and neonatal health. The abstract states that SSRIs have been associated with increased risks of birth defects, miscarriage, preterm delivery, newborn behavioral syndrome, persistent pulmonary hypertension of the newborn (also known as PPHN) , as well as long-term neurobehavioral effects.

For millions of women who are currently taking anti-depressive medications such as Zoloft, Prozac and Paxil and who are planning to start a family, the medical community cautions that there is little concrete evidence of improved pregnancy outcomes with antidepressant use. Unless depression is severe, many health care professionals advise patients to consider cognitive-behavioral therapy and regular physical exercise to help lessen depressive symptoms and avoid the slight risk of having a baby with SSRI birth defects.

Over the past decade, clinical studies on SSRI and pregnancy outcomes have not yielded consistent results. Some research has reported incidents of low birth weight, but the same rates of neonatal complications, while others have indicated a higher risk for life-threatening heart defects.

Pregnant women who expose their babies to SSRIs in the third trimester have reported a greater rate of low Apgar scores, symptoms of respiratory distress, hypoglycemia and lower gestational age. While the jury is still out on the safety of antidepressants during pregnancy, the risk of birth defects – while comparatively low – still exists.

SSRIs during late pregnancy may increase PPHN risk

One of the most life-threatening birth defects linked to SSRI exposure in utero, persistent pulmonary hypertension of the newborn is a serious condition in which the normal circulatory transition fails after birth, resulting in immediate and long-term health problems. Under normal circumstances, PPHN affects roughly one in every 500-1500 births. However, research conducted in five Nordic countries determined that “the risk of persistent pulmonary hypertension of the newborn is low, but use of SSRIs in late pregnancy increases that risk more than two-fold.”

These findings were published in the British Medical Journal in January of 2012. Scientists found that PPHN rates were greater in newborns that were exposed to SSRIs including Zoloft, Paxil, Celexa and Prozac in the womb, and that this doubled risk was evident when exposure began after gestational week twenty.

In 2006, the U.S. Food and Drug Administration published a Public Health Advisory on the treatment challenges of depression during pregnancy and PPHN risks. Federal regulators reference a 2006 study issued in the New England Journal of Medicine, stating:

“In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant 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…. 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.”

Prior research on Paxil during pregnancy revealed that patients who took the antidepressant in the first trimester had twice the likelihood of having a child with heart defects compared to those who took alternative antidepressants. The FDA ordered GlaxoSmithKline to revise Paxil warning labels to a Class D – indicating the antidepressant had been shown to cause serious birth defects in utero.

Antidepressants and pregnancy risks still uncertain

SSRIs sold under the brand names Zoloft, Lexapro, Paxil, Celexa, Symbyax, Prozac and Fluvoxamine are commonly prescribed in the U.S., and antidepressant use has risen more than 400% over the past twenty years according to recent statistics.

While these selective serotonin reuptake inhibitors may be effective in reducing anxiety and negative mood disorders, mounting evidence suggests that antidepressants during pregnancy may put the fetus at greater risk for a range of severe neonatal problems.

In addition to heart defects like PPHN, SSRIs have been associated with the following birth defects:

• Neural tube defects like spina bifida – an incomplete closure of the embryonic neural tube
• Craniosynostosis – a malformation of the infant’s skull
• Omphalocele – an abdominal wall defect where internal organs remain outside the abdomen
• Deformities such as cleft palate and club feet
• Cardiac defects including Hypoplastic Left Heart Syndrome (HLHS) – undeveloped parts of the left side of the heart
• Septal defects (both ASD and VSD)
• Tetralogy of Fallot (TOF) – a cyanotic cardiac defect characterized by four anatomical abnormalities

Long-term prognosis for children with SSRI birth defects

Children who are born with neural tube defects, cranial and heart malformations, and other birth defects will likely face a lifetime of extensive medical treatment. Surgical intervention may be necessary shortly after birth, though the exact course of action will vary depending on the type and severity of neonatal complications. Infants who suffer cardiac defects like Hypoplastic Left Heart Syndrome and septal defects often have to endure several operations and open-heart procedures throughout their lives.

Those who were diagnosed with PPHN may be put on a ventilator for oxygen therapy, given blood pressure medications and antibiotics and need surgery to repair the normal pathway of blood circulation.

For dozens of families who claim they weren’t adequately warned about the dangers of antidepressants and pregnancy, legal action may be their only hope for paying hospital bills and ensuring their child receives the best care possible.

Pending litigation against Zoloft manufacturer Pfizer has already been consolidated on the federal level , with more than 500 Zoloft lawsuits coordinated as multidistrict litigation in Pennsylvania district court.

Plaintiffs who file SSRI lawsuits argue that antidepressant use while pregnant caused their babies to suffer birth defects. Causes of action listed in the complaints include failure to warn of SSRI birth defect risks, negligence and breach of warranties.

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