Heart attack victims face increased risk of death with Natrecor

Apr 20 2005

In a recent study Jonathan Sackner-Bernstein, a doctor at North Shore University Hospital in New York says that Natrecor, heart failure treatment produced by drug company Johnson & Johnson may be linked to a greater risk of death when compared with standard therapy.

In studies of nearly 900 heart failure patients, 7.2 percent of patients died within 30 days of treatment with Natrecor compared with a 4 percent death rate among a control group.

The authors came to the conclusion, that Natrecor, generic name Nesiritide, may be associated with an increased risk of death within the first month after its use and that the possible increased risk of death should be investigated in a large controlled trial.

Heart failure is a chronic condition in which the heart loses its ability to pump blood effectively. The drug Natrecor is usually given when a heart failure patient winds up in the hospital after an acute attack.

Mark Wolfe, Johnson and Johnson's spokesman, says their data shows no statistical difference in mortality, and the company is conducting its own safety review.

In defence Wolfe says these studies were not designed to look at mortality and the patients involved had other fatal medical conditions which could affect results.

Sackner-Bernstein says that the data is the best available and condemns Johnson and Johnson for being irresponsible in not acting on signals of safety problems.

He says the drug has a modest clinical benefit in a high risk situation, where the best data that exists strongly suggests that doctors should be concerned. Based on a review of 1,200 patients the same investigators have also found that the drug worsened kidney function by as much as 50 percent. Reduced kidney function is a well-known side effect of Natrecor and it is listed on the label.

In the current article, investigators pooled data from three studies and analysed the mortality effect, not the gold standard of a prospectively controlled trial, and say the findings should be viewed as "hypothesis generating rather than as conclusive evidence of harm".

Still, safety of currently marketed prescription drugs is under the spotlight as two drugs, Merck & Co Inc.'s Vioxx and Pfizer Inc.'s Bextra were recently withdrawn from the market because of safety concerns.

Signals about safety of these drugs were seen in the literature before more serious concerns came to light.