Letter Includes New Natrecor Label Revised in April 2005

Natrecor is a treatment, administered by injection, for patients with acutely decompensated congestive heart failure (ADHF) with dyspnea.  Recent reports in medical journals have raised drug-safety concerns about Natrecor, in particular whether Natrecor might have serious side effects involving kidney function which could result in patient death.

On May 19, 2005 the FDA posted on its web site for MedWatch — The FDA Safety Information and Adverse Event Reporting Program — this announcement about Natrecor:

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).

The Dear Healthcare Professional letter — also known informally in the medical community as a "Dear Doctor" letter — is seemingly intended to accomplish the following objectives:

1. Point out the new information  which Scios has added to the Prescribing Information, or package insert label, for Natrecor;
2. Address the meta-analyses published in the April 20, 2005 issue of The Journal of the American Medical Association (JAMA) and in the March 29, 2005 issue of Circulation; and,
3. Announce that Scios has requested that an independent panel of experts, led by a distinguished cardiologist, Eugene Braunwald (affiliated with Harvard Medical School as well as the Brigham and Women’s Hospital in Boston), review all available studies for Natrecor, with a focus of the drug’s safety profile.

One can read the complete MedWatch 2005 Natrecor safety summary, which includes links to Scios’ Dear Healthcare Professional letter and their revised Natrecor label.  In addition, one can read more about events leading up to this Natrecor Dear Doctor letter.

(Posted by: Tom Lamb)