Fight Dependency

GlaxoSmithKline (GSK) is being sued by the mother of a girl who 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, for Paxil’s alleged hand in her daughter’s predicament. Faith Gibson, who launched the lawsuit against GSK three years ago, claimed the drug company failed to provide adequate information regarding the risks of birth defects for women taking Paxil during pregnancy. Paxil use during pregnancy can cause oral clefts in newborns, according to several studies.

However, the oral clefts are not the only birth defects associated with Paxil. 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. Along with the warning, the FDA 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.” In a later warning, the FDA said that 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.”

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. According to the lawsuit, 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. Gibson’s case is just one example of how serious Paxil birth defects could get. According to studies, other birth defects linked to Paxil are persistent pulmonary hypertension of the newborn (PPHN), omphalocele (an abdominal birth defect), hydrocephalus (water on the brain) and craniosynostosis (misshapen head).

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Tags: birth defects, birth defects lawsuit, health, medicine