Paxil Maker Is Sued By Canadian Mother For Daughter's Birth Defect

GlaxoSmithKline is being sued by a mother for Paxil’s alleged hand in her daughter’s predicament wherein she was born with a hole in her heart which required surgery and about seven months stay in the hospital not to mention the expenses that it entailed. Faith Gibson claimed the drug company failed to provide adequate information regarding the risks of birth defects for women taking Paxil during pregnancy and launched her lawsuit against GSK three years ago. Several studies have suggested that Paxil use during pregnancy can cause cleft lip or palate in newborns.

Paxil is not only associated with the oral clefts birth defects. Paxil or Paroxetine, an antidepressant, has become one of the popular antidepressants since its approval by the U.S. Food and Drug Administration (FDA) in 1993. A study from Sweden found that birth defects were twice as common among Paxil users as among women taking other antidepressants or none at all. Most of the birth defects involved holes and malformations in the chambers of the heart which often heal on their own, but more severe cases must be surgically repaired, the study further stated.

A warning was issued by the FDA three months after Gibson’s daughter Meah was born in 2005, stating that there was an elevated risk of cardiovascular birth defects for children of women taking Paxil during pregnancy. The FDA, along with the warning, also elevated the drug into its second-highest category for risk of birth defects, advising patients that “this drug should usually not be taken during pregnancy.” “Paxil should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future,” said the FDA in a later warning.

The risk of heart defects is about one percent overall and rose to 1.5 to two percent in infants born to women taking Paxil, according to studies cited by the FDA. Gibson, in her lawsuit, alleges that the drug maker knew or ought to have known as early as June 2003 that there was a significant risk of serious adverse cardiovascular complication for newborns whose mothers had taken Paxil during pregnancy. The lawsuit further claims that GSK failed to publicize the problem, failed to apprise Gibson or her physicians of the inherent dangers, and failed to issue a timely recall of the drug.

To be determined by the legal action is whether the drug maker knew and when it knew it before the birth of Gibson’s daughter. One example of how serious Paxil birth defects is Gibson’s case. Persistent pulmonary hypertension of the newborn (PPHN), omphalocele (an abdominal birth defect), hydrocephalus (water on the brain) and craniosynostosis (misshapen head), are the other side effects associated with Paxil as suggested by studies.

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