Paxil Makers Face Lawsuits Related to PPHN and Other Birth Defects

Breckenridge, COThe number of lawsuits against Paxil alleging that use of the drug caused PPHN and other birth defects in newborn babies continues to grow.

A Colorado family has also filed suit against the makers of Paxil, after their son was born with Persistent Pulmonary Hypertension of the Newborn (PPHN). The infant was placed on a ventilator immediately following birth and has undergone two cardiac catherizations. He is still on oxygen and taking medication to help him breathe. The suit claims that GlaxoSmithKline should have warned expectant mothers about the risks of taking Paxil.

PPHN is not the only problem that can be caused by taking Paxil during pregnancy. A 2005 study conducted by GlaxoSmithKline, makers of Paxil, found that infants who were exposed to Paxil while in the womb had a risk of heart malformations 1.5 times higher than that of other antidepressants.

One Texas family filed a lawsuit against GlaxoSmithKline after their son was born with a heart malformation. Although he is two-and-a-half years old, he has already had three open heart surgeries because he was born with a double outlet on the right ventricle of his heart. The family claims that GlaxoSmithKline knew about the risks of taking Paxil while pregnant but failed to properly warn the public about those risks.

An Ohio family filed a lawsuit late last year against GlaxoSmithKline after a mother gave birth to twin girls who had heart defects. One of the twins died after four surgeries to repair the heart defects. Meanwhile the other twin has a hole in her heart and will require regular monitoring as she ages.

A South Carolina family has also filed a lawsuit against GlaxoSmithKline after a mother took Paxil while pregnant and delivered a baby with heart defects so severe she required two open-heart surgeries during her first year of life. The heart defect requires the child to take medication throughout her life that will prevent her from becoming pregnant and she will not be able to participate in activities that require physical exertion such as dancing or cheerleading.

In November, 2006, the American College of Obstetrics and Gynecologists Committee on Obstetric Practice recommended that women who are pregnant or plan on becoming pregnant should avoid the use of Paxil if possible.

Last year, the New England Journal of Medicine published a study that highlighted the risks of Persistent Pulmonary Hypertension of the Newborn in babies whose mothers took Paxil and other SSRIs while pregnant. According to the study, "Persistent Pulmonary Hypertension of the Newborn (PPHN) occurs in an estimated 1 or 2 infants per 1000 live births and is associated with substantial morbidity and mortality. Despite treatment, 10 to 20 percent of affected infants will not survive."

The authors of the study found "a significant association between exposure of a mother to an SSRI during late pregnancy and the occurrence of PPHN in her infant. This finding is consistent with an earlier observation in a small cohort study."

Paxil is Category D because it has been shown to have a risk to the health of a fetus.

In addition to PPHN and other birth defects, Paxil has also been linked to an increased risk of suicide in patients under the age of 18.