Reactions 1071 - 1 Oct 2005

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Congenital malformation warning added to US Paxil/Paxil CR labels The Precautions sections of the US labelling for Paxil [paroxetine] and Paxil CR (Controlled-release) tablets have been updated to highlight preliminary results from a recent retrospective epidemiological study that suggested that paroxetine use during the first trimester of pregnancy may increase the risk of overall major congenital malformations compared with other antidepressants, according to a ‘Dear Healthcare Professional’ letter issued by GlaxoSmithKline (GSK). GSK says that the congenital malformations observed in the study were mainly cardiovascular, and were reflective of congenital malformations seen in the general population. The company says that healthcare providers should weigh the potential risks and benefits of paroxetine use in pregnant women, and discuss treatment alternatives and the findings of the recent study with their patients. GlaxoSmithKline. GlaxoSmithKline would like to advise you that it is changing the Pregnancy subsection of the PRECAUTIONS section in the labels for PAXIL (Rm) (paroxetine HCl) and PAXIL CR (Rm). Prescribing Information : [5 pages], 801013166 Sep 2005. Available from: URL: http://www.fda.gov

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Reactions 1 Oct 2005 No. 1071