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Natrecor: A Definitive Safety Study Is Long Overdue

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 And unpublished data from a new study of the drug in patients undergoing heart-bypass surgery indicated that Natrecor might protect kidneys from damage related to the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)

3 responses to “Natrecor: A Definitive Safety Study Is Long Overdue”

  1. Wendy Avatar
    Wendy

    My father is a victum of off labeling experiments with Natrecor.
    He has suffered heart attacks, kidney failure, and his lungs are only working 50% since he was given Natrecor which was put directly into his kidneys at Scripps Hospital. This was done without the approval of the FDA and was Sponsored by Scios and a company named Flowmedica, Inc., which the research doctor owns an interest in. My father was lied to, and information about the dangers and warnings were with held from my father and his family.
    Wake up world, the money is what it is about, not human life.

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    Clinical trials of drugs are supposed to be done according to certain standards of conduct. To the extent you believe that there was any violation of those standards, I encourage you to contact the FDA or some other regulatory organization.
    Let me know if you need any assistance.
    Thank you for reading Drug Injury Watch.
    Tom Lamb

    Reply
  3. Wendy Avatar
    Wendy

    I don’t know the best way to answer your question about the FDA and the Natrecor test that my father was in. The answer is “yes” I did call the FDA and they had an inspector on the case. They do not inform the person making the complaint as to what action, if any, takes place.
    Now the test results are being taken to Medical summits and written about in reasearch articles saying that this drug is proving to be safe for the kidneys. The truth of my father, which was just one man of 15, and we do not even know if any of those victims are alive or ill like my father. I was laughed at by the doctor who told me it was my father that was just an old sick man. My father was able to walk into the hospital and left half dead. The consent form was full of lies and all the truth about Natrecor was never disclosed. My father had weak kidneys before the test and that is why he was chosen…as it said in the agreement,” Natrecor is good for you and will protect your kidneys from the dye of an angiogram.”
    The research team never checked my father to see what condition he was in, they only got copies of his medical records from UCLA-Santa Monica Hospital once my father was released. I told them that he had died and was on life support, and they never called back.
    Now there is more test being promised, 100 million dollars to be spent….does that also coverup more lies and test results that are fixed?
    All that SCIOS and J&J seem to get are the ability to legally kill more people and have business grow.

    Reply

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