Daniel Mines, Patricia Tennis, Suellen M Curkendall, De-Kun Li, Craig Peterson, Elizabeth B Andrews, Brian Calingaert, Hong Chen, Gaurav Deshpande, Daina B Esposito, Nicholas Everage, Crystal N Holick, Nicole M Meyer, Ella T Nkhoma, Sherry Quinn, Kenneth J Rothman, K Arnold Chan
PURPOSE: First marketed in the USA in 1996, topiramate (TPM) is an antiepileptic drug later approved for migraine prophylaxis, and in 2012 for weight loss in combination with phentermine. Some studies indicate an elevated prevalence of oral cleft (OC) in infants exposed to TPM in utero. We evaluated the association between TPM use in early pregnancy and the risk of OC. METHODS: This retrospective cohort study used 1997-2011 automated data from four sources: HealthCore and OptumInsight (commercial insurance claims), Truven Health (Medicaid claims), and Kaiser Permanente Northern California Region (electronic medical records)...
October 2014: Pharmacoepidemiology and Drug Safety