GSK Statement on Jury Verdict in Paxil Product Liability Trial in Philadelphia Court of Common Pleas
http://www.network54.com/Forum/281849/message/1255502569/GSK+statement+on+Jury+verdict+in+Paxil+product+liability+trial+-+Kilker+case
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
No comments:
Post a Comment
Note: only a member of this blog may post a comment.