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General News    H4'ed 3/3/10

Cold Case Files - Paxil Birth Defects

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The document stated in part: "There have been 17 reports of congenital abnormality reports to the MHW."


It also stated: "The company should consider it important that this many cases have appeared."


The document contained a table with a list of adverse event reports collected on birth defects and birth outcomes, based on an internal review of information received about pregnancies, that showed 32 reports of abnormal outcomes with congenital anomalies.


The company had information on a total of 635 pregnancies in general but only knew the outcomes for 315 infants. "So about half they don't know what happened," Parisian explained.


You don't "know what has happened to those babies at all," she stated.


Parisian testified that Glaxo internally had reports that looked at all birth defects known to the company, which she had reviewed prior to the trial.


One of the reports was titled, "Paroxetine in Pregnancy," on adverse events and pregnancy outcomes.


This analysis had a cutoff date of May 1996, and would include the knowledge of the company on pregnancies from the date Paxil was approved in 1992, through May of 1996, Parisian said. The table in this report showed 36 cases of abnormal or congenital outcomes.


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Evelyn Pringle is an investigative journalist and researcher focused on exposing corruption in government and corporate America.
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