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Natrecor FDA Alerts

The FDA Alert(s) below may be specifically about Natrecor or relate to a group or class of drugs which include Natrecor (nesiritide).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for nesiritide

Natrecor (nesiritide) - Jul 18, 2005

Jul 18, 2005

Audience: Cardiologists/cardiovascular healthcare professionals

[Posted 07/18/2005] 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.

[July 13, 2005 -

Natrecor (nesiritide) - May 19, 2005

May 19, 2005

Audience: Cardiologists/cardiovascular healthcare professionals

Scios and FDA notified healthcare professionals of revisions to the ADVERSE REACTIONS/Effect on Mortality section of the prescribing information for Natrecor [nesiritide], indicated for patients with acutely decompensated congestive heart failure. The Dear Healthcare Professional letter also provided information from Scios on several published reports that raise the question of whether the product may have adverse effects on survival and kidney function compared to control agents (generally nitroglycerin and diuretics).

[May 6, 2005 - Dear Healthcare Professional Letter - Scios]
[April, 2005 - Natrecor Label - Scios]

More Natrecor Resources