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General News    H4'ed 3/3/10

Cold Case Files - Paxil Birth Defects

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A 13.3 percent rate "would be a type of signal that a manufacturer should address," she testified.


Another exhibit reviewed for the jury showed the Japanese had received 27 reports of congenital abnormalities since December 1998 and they were requesting more information about safety, and included emails written by Glaxo employees, Ann Bell and Narita San.


An email written by Narita San stated in part: "This is unexpected number of reports, because only 50 cases were reported in the previous position paper. I think we have to take this abrupt increase of reports into consideration to the reply."


Parisian explained that "the Japanese are saying that they have received 27 reports of congenital anomalies and they want an update on the prior information."


In 2000, another internal report of the adverse events for pregnancy outcomes was completed by Doctor Stephen Hughes, Ms Easterbrook and Ms Caley, the worldwide clinical safety group, updating the report made in 1998, Parisian said.


The analysis, with a cutoff date of March 2000, showed Glaxo knew the outcome of 656 pregnancies, out of a total of 1,189 known Paxil pregnancy exposures. By then, there were 79 reports of congenital abnormalities, meaning 12 percent of pregnancies with known outcomes resulted in birth defects.


It was possible that some of the babies in the pregnancies with unknown outcomes also had birth defects, Parisian said. "They are unknown what they had."


While testifying, Parisian was asked to explain the general rule of "underreporting."


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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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