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You are here: Home / Product Recalls / Baby Products / SSRI Antidepressants and Birth Defects: Lawsuits Increase but Evidence Remains Unclear

SSRI Antidepressants and Birth Defects: Lawsuits Increase but Evidence Remains Unclear

December 3, 2012 By Candelaria Leave a Comment

Some studies suggest that when women take SSRI antidepressants, their baby may be at an increased risk for certain types of birth defects. These birth defects are mostly heart defects that may require additional surgery and may have a lifelong impact on the child. Although more and more parents are seeking compensation for these defects, further studies have failed to clarify the connection between this class of drugs and birth defects.

What Are SSRIs?

SSRIs, short for selective serotonin reuptake inhibitors, are a class of antidepressants that are intended to elevate levels of the hormone serotonin. Higher serotonin levels are associated with a generally more positive mood. SSRIs work by reducing the rate at which your body removes serotonin from your system to help the hormone build up.

SSRIs include:

  • Celexa (citalopram)
  • Lexapro (escitalopram)
  • Paxil (paroxetine)
  • Prozac (fluoxetine)
  • Zoloft (sertraline)

Although they are called antidepressants, they are often prescribed for anything from obsessive-compulsive disorder to anxiety in addition to depression.

Birth Defects Associated with SSRIs

The first evidence that SSRIs were associated with birth defects came in 2005 when GlaxoSmithKline called attention to safety data suggesting that exposure to SSRIs during the first trimester might double the risk of birth defects. The majority of birth defects seemed to be cardiovascular, related to the heart. Since then, research has suggested that many types of birth defects may be associated with SSRI use during the first trimester, including:

  • Ventricular septal defect (heart defect)
  • Atrial septal defect (heart defect)
  • Hypoplastic Left Heart Syndrome (HLHS, heart defect)
  • Tetralogy of Fallot (heart defect)
  • Omphalcele (abdominal wall defect)
  • Craniosynostosis (head and face malformation)
  • Clubfoot and other limb malformation
  • Persistent Pulmonary Hypertension of the Newborn (PPHN)

Some of these defects may be detected at birth or during pregnancy. Others may take time to be detected.

How High Is the Risk of Birth Defects?

Many studies have been done on the risk of birth defects associated with SSRIs. When used during the first trimester, it seems that the absolute risk of birth defects is low, but the type of defects can be more serious malformations: heart, head, abdomen and limb defects. Most studies suggest that the risk is 1.5-2 times that of women who use other types of antidepressants.

When used late in pregnancy, the risk of some effects seems very high. One study suggested that this risk may be as high as 20-30%. This includes agitation, abnormal muscle tone, and seizures. PPHN, a serious condition affecting an infant’s circulation and ability to get oxygen normally, occurs in about 3 in 1000 births when the mother is taking SSRIs. Normally PPHN only occurs in about 1.2 in 1000 births.

Other studies show that SSRI use is not associated with these risks. Some studies suggest that Paxil (paroxetine) is associated with a higher risk than other SSRIs, but most suggest that the risk is the same for all SSRIs.

The bulk of evidence, including a recent large Danish study of SSRI birth defects, suggests that there is some increased risk for the class.

Lawsuits Associated with SSRIs and Birth Defects

Although the science is conflicting, many women who took SSRIs during pregnancy are seeking compensation if their children are born with birth defects. Hundreds of lawsuits have been filed related to Paxil, Zoloft, and other SSRIs. One went to a jury trial, resulting in a $2.5 million verdict. Others have been settled out of court. Many are being consolidated in federal court.

Women who are being prescribed SSRIs during pregnancy should talk to their doctors about these risks. Women prescribed SSRIs during pregnancy whose children have been diagnosed with a birth defect should consider contacting a lawyer.

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Filed Under: Baby Products, Medical Devices, SSRI

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