A Danish study shows that the risk is greatest when moms-to-be take more than one selective serotonin reuptake inhibitor (SSRI) antidepressant or switch SSRIs early in pregnancy. Babies born to women who had filled prescriptions for more than one SSRI had a fourfold increase in septal heart defects — a malformation of the wall that divides the left and right sides of the heart.
A judge has mandated Glaxo provide emails between it and researchers who were looking into the Paxil-birth defect connection. U.S. District Judge Nancy Gertner in Boston ruled “the plaintiffs are entitled to correspondence and documents between anyone at Slone and GSK about the study, its scope” and methodology.
The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son. Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.