A potential link between Paxil and birth defects has been reported in published studies including one in the New England Journal of Medicine.

Paxil (paroxetine) is in a class of drugs known as Selective Serotonin Reuptake Inhibitors (SSRIs). SSRIs work by increasing or restoring serotonin levels in the patient’s brain, which can help relieve depression. Paxil is used to treat patients with major depressive disorder and obsessive-compulsive disorder.

The FDA released a public health advisory in December 2005 warning that women taking Paxil during the first trimester of pregnancy may have an increased risk of delivering a child with heart birth defects. The agency also announced that, due to the potential risk of Paxil birth defects, the drug would be moved to pregnancy category D, indicating that human research suggests the drug poses a risk to a fetus.

While the FDA has associated Paxil use during pregnancy with holes in the heart, studies have linked the use of SSRI drugs during pregnancy to other birth defects. The most common birth defects linked to the use of SSRIs like Paxil include:

• Heart defects
• Craniosyntosis
• Cleft palate
• Cleft lip
• Club foot

In February, 2006, the New England Journal of Medicine published a study suggesting that babies exposed to antidepressants such as Paxil in the last trimester were six times more likely to be born with Persistent Pulmonary Hypertension of the Newborn or PPHN than babies who were not exposed to SSRIs.

According to the report, up to 12 newborns in 1,000 developed persistent pulmonary hypertension after exposure to SSRIs during pregnancy, versus one to two newborns on average.

Babies born with PPHN have abnormal blood flow through their heart and lungs, and their bodies are deprived of oxygen. This lack of oxygen can cause organ failure in the infant’s brain and kidneys. Approximately 20 percent of babies born with PPHN do not survive, and those that do may have long-term breathing problems.

However, in December 2011, the FDA said any link between the use of SSRI medications while pregnant and the development of PPHN is premature.

Paxil Birth Defects Lawsuits

Because the manufacturer failed to warn patients of birth defect risks, women who took the SSRI Paxil during pregnancy and delivered a child with birth defects may have legal recourse.

If your child was born with birth defects following use of Paxil during your pregnancy, you may be able to seek financial compensation for your child’s injuries through a birth defects lawsuit.