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GSK is sued in US over alleged link of paroxetine to birth defects

BMJ 2009; 339 doi: (Published 12 October 2009) Cite this as: BMJ 2009;339:b3967
  1. Janice Hopkins Tanne
  1. 1New York

    GlaxoSmithKline (GSK) is facing the first of about 600 US lawsuits claiming that its antidepressant paroxetine (marketed as Paxil in the United States and Seroxat in the United Kingdom) caused birth defects in infants born to mothers who took the drug while pregnant. The first case has gone to jury in Philadelphia, Pennsylvania, where the company has locations in the city and its suburbs. The outcome of early trials often sets the trend for later cases.

    In the Philadelphia case Michelle David claims that the drug caused life threatening heart defects in her son Lyam Kilker, who has had heart surgery several times. He is now almost 4 years old.

    Lyam’s lawyer alleged in court that documents disclosed in the proceedings suggested that GSK had been aware in 1980 that information from rat studies indicated that paroxetine “could be” a cause of birth defects but that the company had decided to ignore them, reported Bloomberg, the financial news service (, 15 Sep, “Glaxo executive’s memo suggested burying drug studies”).

    A 1998 internal review by GSK of all reports of side effects tied paroxetine to an “alarmingly high number” of reports of birth defects, but the review report was not forwarded to the US Food and Drug Administration, the lawyer also alleged. It was not until 2003, when the …

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