Natrecor damages kidney, no recall yet

According to an article published in the medical journal Circulation, Natrecor (nesiritide), made by Johnson & Johnson (Scios Inc.), caused a 40 percent to 50 percent greater risk of reduced kidney function when compared with more conventional therapies for heart patients. Natrecor is used to treat patients with congestive heart failure who have shortness of breath at rest or with a small amount of activity.

Over 5 million people in the United States have congestive heart failure. Each year, there are an estimated 400,000 new cases, and half of those diagnosed with the condition will be dead within five years. Natrecor (nesiritide) Injection, a synthetic version of a human hormone, works by dilating the veins and arteries so more blood can flow through them. Decompensated heart failure results in nearly one million hospitalizations annually, the most common reason for hospitalization among people over age 65.

The FDA approved the drug in 2001 and had a rather simple warning that patients need to tell their doctor about their kidney problems. The most common side effect with Natrecor is low blood pressure, the FDA says. FDA based its approval on scientific data from a number of controlled clinical trials in people with acute CHF, including the Vasodilatation in the Management of Acute Congestive Heart Failure Trial (the VMAC study). The VMAC study involved a total of 489 patients who required hospitalization for the management of shortness of breath at rest due to CHF. VMAC participants were randomized and treated with Natrecor, intravenous nitroglycerin or placebo (for 3 hours). In the VMAC study, patients receiving Natrecor reported greater improvement in shortness of breath than patients receiving placebo.
The company says that Natrecor may affect renal function in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with the drug may be associated with azotemia.
European Medicines Agency (EMEA) has not yet approved Natrecor.

"Nesiritide was associated with a 40 to 50 percent higher risk of worsening kidney function when used for the treatment of acutely decompensated heart failure," reported Jonathan Sackner-Bernstein, MD, the study's principal investigator and director of clinical research at the Heart Failure and Cardiomyopathy Center at North Shore University Hospital in Manhasset, NY. "This data is based on analysis of the randomized, controlled trials conducted by Scios, which studied the effects of Nesiritide in over 1,200 patients. Whether using low or high doses, Nesiritide was associated with significant risk of kidney dysfunction."

"We're all looking for ways to get our heart failure patients feeling better and discharged from the hospital as quickly as possible," said Keith Aaronson, MD, associate professor in the Division of Cardiovascular Medicine at the University of Michigan, and a co-investigator of the Circulation study. "Nearly all of these hospitalizations occur because patients are short of breath from retaining too much fluid. Many physicians have embraced nesiritide in the belief that fluid can be removed and symptoms improved more quickly without risk. According to the data, that just isn't so."

"As of yet, we do not understand how Nesiritide leads to worsening kidney function in patients with decompensated heart failure. But we do know that worsening kidney function is troubling, in that it generally is associated with a higher risk of death. Together, these observations suggest the need for appropriately sized clinical trials to establish the safety of nesiritide relative to its benefits on symptoms," said Dr. Sackner-Bernstein.