Natrecor (nesiritide): Recommendations of expert panel with respect to recent questions raised about worsened renal funct ion and mortality
July 18, 2005 07:08

Date: Mon, 18 Jul 2005 14:22:28 -0400
From: CDER MEDWATCH LISTSERV
Subject: FDA MedWatch - Natrecor (nesiritide): Recommendations of expert panel with respect to recent questions raised about worsened renal funct ion and mortality

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Scios and FDA notified healthcare professionals about the recommendations of an expert panel of cardiology and heart failure clinicians with regard to NATRECOR (nesiritide). With respect to recent questions raised about worsened renal function and mortality, the panel provided a consensus statement on each issue, provided advice on the ongoing and planned clinical development program, made recommendations about the appropriate use of the drug and recommeded an educational campaign to ensure that clinicians understand when the use of NATRECOR is appropriate and when it is not appropriate.