ARTICLE | Clinical News
Antara fenofibrate regulatory update
May 9, 2011 7:00 AM UTC
FDA issued a new quarterly report on safety information emerging from its Adverse Events Reporting System (AERS) during 4Q10 in which the agency identified a "paradoxical" reduction in HDL cholesterol in patients receiving fenofibrate products. FDA is evaluating the reports to determine if regulatory action is needed. ...