Comments on: Glaxo Must Pay $2.5M Over Paxil & Birth Defects http://www.pharmalot.com/2009/10/glaxo-must-pay-25m-over-paxil-birth-defects/ News, Comment and Conversation Sun, 21 Mar 2010 21:50:24 +0000 http://wordpress.org/?v=2.6.2 By: Joshua http://www.pharmalot.com/2009/10/glaxo-must-pay-25m-over-paxil-birth-defects/#comment-437713 Joshua Fri, 16 Oct 2009 07:12:00 +0000 http://www.pharmalot.com/?p=19041#comment-437713 GSK lost its first case involving Paxil birth defects: http://www.newsinferno.com/archives/13348 GSK lost its first case involving Paxil birth defects: http://www.newsinferno.com/archives/13348

]]> By: Lisa Van Syckel http://www.pharmalot.com/2009/10/glaxo-must-pay-25m-over-paxil-birth-defects/#comment-437090 Lisa Van Syckel Wed, 14 Oct 2009 13:27:00 +0000 http://www.pharmalot.com/?p=19041#comment-437090 WOW,.. GSK speaks! I have but one question for the individuals who have penned their names to this press release,... How do you sleep at night knowing that this drug mames and kills children around the world? WOW,.. GSK speaks! I have but one question for the individuals who have penned their names to this press release,… How do you sleep at night knowing that this drug mames and kills children around the world?

]]> By: J Lyons http://www.pharmalot.com/2009/10/glaxo-must-pay-25m-over-paxil-birth-defects/#comment-436991 J Lyons Wed, 14 Oct 2009 06:53:41 +0000 http://www.pharmalot.com/?p=19041#comment-436991 GSK Statement on Jury Verdict in Paxil Product Liability Trial in Philadelphia Court of Common Pleas On October 13, 2009, a jury in the Philadelphia Court of Common Pleas returned a verdict against GlaxoSmithKline in a case alleging that Lyam Kilker was born with a rare heart defect as a result of his mothers use of Paxil during pregnancy. GlaxoSmithKline disagrees with the verdict and will appeal. While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy. GlaxoSmithKline acted properly and responsibly in conducting its clinical trial program for Paxil, including sharing documentation and submitting results from studies on Paxil to regulators. Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicines labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public. US Media enquiries: Nancy Pekarek (919) 483 2839 Mary Anne Rhyne (919) 483 2839 Kevin Colgan (919) 483 2839 Sarah Alspach (919) 483 2839 GSK Statement on Jury Verdict in Paxil Product Liability Trial in Philadelphia Court of Common Pleas

On October 13, 2009, a jury in the Philadelphia Court of Common Pleas returned a verdict against GlaxoSmithKline in a case alleging that Lyam Kilker was born with a rare heart defect as a result of his mothers use of Paxil during pregnancy.

GlaxoSmithKline disagrees with the verdict and will appeal. While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy.

GlaxoSmithKline acted properly and responsibly in conducting its clinical trial program for Paxil, including sharing documentation and submitting results from studies on Paxil to regulators. Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicines labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public.

US Media enquiries:
Nancy Pekarek
(919) 483 2839
Mary Anne Rhyne
(919) 483 2839
Kevin Colgan
(919) 483 2839
Sarah Alspach
(919) 483 2839

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