Off-label Use Of Natrecor Continues To Be A Problem
A year ago two medical journal articles raised serious safety issues about Natrecor; in summary: (1) a 50% increased risk of kidney damage or renal failure; and, (2) a 75% increased risk of Natrecor-associated death within 30 days of use when compared to similar drugs.
At that point in time Scios, the Johnson & Johnson subsidary which makes Natrecor, convened a panel of experts who told the drug company that a study of these safety issues should be done immediately.
What happened? According to a May 30, 2006 article in The Wall Street Journal, Johnson and Johnson (J&J) recently provided this update about their new Natrecor safety study:
"There are just a couple of details that we're putting the finishing touches on," said Roger Mills, vice president of medical affairs at Scios, the J&J unit that makes Natrecor. . . .
[Another] company spokeswoman said the study would be the largest and most comprehensive to date in this group of patients. The study, she said, will demonstrate the "commitment and confidence" the company has in Natrecor.
This one-year delay in launching this Natrecor study, according to the May 30 WSJ article, drew a scathing comment from Milton Packer, a member of the advisory committee convened by J&J a year ago: "I think no one on the panel imagined that the recommendation would be followed by silence for a year. . . . It's an unacceptably long period of time."
On other fronts, the WSJ's Scott Hensley reported:
J&J said in a recent quarterly securities filing that "there is no new data supporting the conclusions" of the safety critics. And unpublished data from a new study of the drug in patients undergoing heart-bypass surgery indicated that Natrecor might protect kidneys from damage related to the operations. . . .
The FDA hasn't asked J&J for a safety study of Natrecor.
In part, it is the so-called "off-label" prescribing of Natrecor (nesiritde) -- an infusion in outpatient clinics to avoid acute congestive heart failure episodes with severe breating problems vs. use in hospitalized patients whose hearts pump so weakly that they have trouble breathing -- which has contributed to the growing controversy about J&J's Natrecor.
Meanwhile, perhaps due to the Natrecor side effects controvery, according to this May 30, 2006 WSJ article the sales of Natrecor has gone from $375 in 2004 to a projected $100 million in 2006.
The fate of Natrecor remains to be seen.
(Posted by: Tom Lamb)