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General News    H4'ed 3/3/10

Cold Case Files - Paxil Birth Defects

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It is general "knowledge that adverse events that the FDA receives are underreported," she said. "The FDA's numbers range from 1 to 10 percent."


So the FDA looks at the adverse event reports they receive as the tip of the iceberg, "maybe 10% of the reports that are actually out there," she pointed out.


If talking about underreporting figures for 79 cases of congenital defects, she said, "that would be 1 percent maybe to 10 percent, which would be 7,900."


"That would be babies that actually lived to getting born," she told the jury. "That's nothing to do with the miscarriages and what is not known."


The reports discussed during her testimony, "were not your classic safety analysis," Parisian explained. They were a "reporting or a tabulation of what information the company had."


They were being prepared for the Japanese because the Japanese government wanted safety information on pregnancy outcomes and they were also concerned about "late pregnancy, what the behavior would be of the baby when the baby was born if the mother was taking Paxil," she told the jury.


But under the rules, Glaxo was required to turn over any internal safety reviews, reports, and analysis to the FDA, Parisian told the jury, "particularly with pregnancy, which the FDA has been asking for information since the product was approved."


None of the analyses were turned over to the FDA, according to the testimony of Glaxo employees, Parisian said.


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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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