Birth Defects: Antidepressants and Pregnancy

Women taking selective serotonin reuptake inhibitors (SSRIs), such as Zoloft, Celexa, Lexapro, Paxil, or Prozac face a difficult decision if they become pregnant. Over the last twenty years, various reports and medical studies have addressed the reproductive safety of SSRI antidepressants, indicating an increased risk of serious birth defects. SSRIs are the most widely prescribed class of antidepressant, yet emerging research suggests that babies who are exposed to drugs like Zoloft in utero have a heightened chance of developing SSRI birth defects, including heart malformations, spina bifida, and persistent pulmonary hypertension of the newborn (PPHN), among other congenital defects.

Use of antidepressants has increased 400 percent over the past two decades, making drugs like Paxil and Zoloft the most frequently prescribed medications for patients between the ages of 18 and 44. The potential dangers of antidepressants and pregnancy have been cited in several medical journals, and Class D drugs such asPaxil (paroxetine) are no longer recommended for expectant mothers, as the SSRI showed a demonstrated risk of heart defects to the fetus. On the other hand, SSRIs that are labeled Class C, including Zoloft (sertraline), Celexa (citalopram) and Prozac (fluoxetine), are still commonly prescribed to pregnant women despite clinical trials showing SSRI birth defects in animal subjects.

FDA warns of antidpressants and pregnancy

On December 8, 2005, the Food and Drug Administration (FDA) published a safety communication regarding the increased risk of congenital heart defects linked to Paxil. The agency stated that “new studies for Paxil suggest that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.” Research demonstrated that women who ingested Paxil during the first trimester of pregnancy were almost twice as likely to have a baby with a heart defect as women who took other types of antidepressants. The federal agency asked Paxil manufacturer, GlaxoSmithKline, to change their pregnancy warning label from a C to a Class D – signifying that the drug carried a known risk of SSRI birth defects to the human fetus.

Yet another warning regarding the hazards of  antidepressants and pregnancy came in 2006, when the FDA issued a public health advisory concerning neonatal PPHN and use of selective serotonin reuptake inhibitors.

Among the SSRIs included in the 2006 advisory:

• Zoloft
• Celexa
• Fluvoxamine
• Lexapro
• Paxil
• Prozac
• Symbyax

PPHN is a critical condition that affects an infant’s lungs and heart, and has been associated with significant fatality. The warning was based on a New England Journal of Medicine study revealing that women who took SSRIs after the 20th week of pregnancy were six times more likely to have babies born with PPHN. This SSRI birth defect occurs when a newborn does not adapt to breathing outside the womb. Babies with PPHN often require intensive care and may suffer brain and organ damage – or even death – in more dire cases.

The FDA cautioned health care providers and their patients to weigh the risks of SSRI use during pregnancy against those associated with stopping treatment of depression during pregnancy.

SSRI birth defects

Since their launch in the late 1980’s, SSRIs have gained popularity for treating a range of disorders including depression and anxiety, and their more common side effects were well tolerated by most. However, study after study has shown that SSRIs and pregnancy can be a risky combination when it comes to fetal health and development.

SSRI birth defects are not limited to PPHN, as the drugs have also been linked to neural tube defects in recent studies. Researchers discovered incidents of anencephaly, craniosynostosis and omphalocele in a higher number of newborns whose mothers had taken SSRIs during pregnancy or before conception.

The following are some of the birth defects attributed to SSRIs:

• Tetralogy of Fallot (TOF)
• Persistent pulmonary hypertension of the newborn (PPHN)
• Craniosynostosis
• Omphalocele
• Spina bifida
• Club foot
• Cleft palate
• Heart murmur
• Ventricular Septal Defects (VSD)
• Atrial Septal Defects (ASD)
• Hypoplastic Left Heart Syndrome (HLHS)

Treatment options for birth defects

Babies who have suffered Zoloft side effects in utero, or birth defects caused by other SSRIss, may face a lifetime of costly and intensive medical care. Depending on the type of SSRI birth defect, the prescribed course of treatment may vary:

• Treatment for PPHN often includes assisted ventilation to help improve the infant’s oxygen levels. In other cases, a type of procedure called extracorporeal membrane oxygenation (ECMO) may be indicated. ECMO involves major surgery, is frequently complicated to monitor, and has potentially fatal side effects. This treatment is reserved for the sickest babies who are not responding to other therapies.
• Heart defects such as VSD, ASD and Tetralogy of Fallot almost always necessitate surgical intervention shortly after birth. These are some of the most serious side effects in newborns alleged by mothers who take SSRIs during pregnancy. Babies may have to undergo multiple open-heart surgeries or even need a heart transplant as they age to correct these congenital defects.
• Depending on the severity of spina bifida, surgery may also be indicated to repair the meninges and minimize the risk of infection from neural tube defects. In cases of irreparable nerve damage, a child may experience paralysis and bowel problems and require ongoing rehabilitation from a team of physicians and specialists.
• Craniosynostosis, where a baby’s cranial sutures close prematurely, resulting in skull abnormalities, can cause increased intracranial pressure, seizures and developmental delays. Surgery is performed while the child is still young to relieve pressure on the brain and allow sufficient room for future brain growth.
• Another risk of mixing antidepressants and pregnancy, omphalocele is a type of hernia where the abdominal organs protrude out of the naval, covered only by a thin membrane. The outlook is generally good following surgery, but babies are at risk for intestinal infection.
• Club foot is a complex deformity where the foot and part of the leg turns down and inward. Non-surgical treatment options include manipulation and casting, taping, physical therapy and splinting. In more severe cases, surgery may be necessary and is normally performed when the child is between six months and one year old.

Legal options for parents and children

Available research suggests that SSRI use among expectant mothers, especially when it extends beyond the first trimester, can result in increased risks for severe birth defects. Dr. Alice Domar of the Beth Israel Deaconess Medical Center, who led a recent study on antidepressants and pregnancy said, “There is enough evidence to strongly recommend that great caution be exercised before prescribing these drugs to women who are pregnant or who are attempting to get pregnant, whether or not they are undergoing infertility treatment.” The findings were published in the Journal Human Reproduction, on October 31, 2012.

Legal recourse is available to those who took SSRI medications such as Zoloft, Celexa, Paxil, Prozac, or Lexapro during pregnancy, and had a baby with birth defects. Across the country, many have already filed claims against manufacturers of SSRI medications, raising allegations of negligence and failure to warn of known risks of birth defects. A successful SSRI birth defects lawsuit can help recover some measure of damages for the terrible ordeal inflicted on those victims.