GSK said that unfortunately, birth defects occur in three to five percent of all live births, whether or not the mother was taking medication during pregnancy.
GSK believes it acted properly and responsibly in researching and studying Paxil, including sharing documentation and submitting results from studies on Paxil to regulators.
GSK claimed that they also believe that once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicine’s labeling as new information became available and communicating important safety information to regulatory agencies, the scientific and medical community and the public.