Drug Injury Watch

Dr. Dennis Mangano Says On 60 Minutes In February 2008 That Trasylol Should Have Been Recalled As Early As January 2006

Delay By Bayer And FDA Until November 2007, When Trasylol Sales Were "Suspended", Caused 22,000 Excess Deaths Per CBS Report

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to interviews broadcast by CBS Television's 60 Minutes program about Trasylol on February 17, 2008, an estimated 22,000 patient lives could have been saved if the FDA had acted quicker to recall Trasylol, Bayer AG's drug used to stem bleeding during open heart surgery.

Trasylol (aprotinin injection) sales in the U.S. and Canada were suspended by Bayer in early November 2007. Trasylol was used to reduce blood loss during coronary artery bypass surgery.

As background, in mid-February 2006 the FDA announced it was evaluating the safety of Trasylol after new studies had linked this heart surgery drug to higher risks of kidney problems, heart attacks, and strokes.  At the end of February 2006 a "Dear Doctor" letter from Bayer regarding Trasylol was posted on Health Canada's MedEffect web site.

Later, the FDA held an advisory committee meeting in September 2006 and, thereafter, convened another such meeting on September 12, 2007 to further discuss Trasylol. 

A February 15, 2008 Reuters article, "22,000 died amid delayed Bayer drug recall: doctor", provided these details based on a review of this 60 Minutes report about Trasylol that had been posted on the CBS News web site in advance of the February 17 broadcast:

Dr. Dennis Mangano, the study's researcher, said during the program that 22,000 lives could have been saved if Trasylol had been taken off the market when he first published his study in January 2006....

He said in the broadcast that Bayer failed to disclose to the FDA during an FDA advisory panel meeting in September 2006 -- at which Mangano's negative findings were discussed -- that the German drugmaker had conducted its own research which confirmed the same dangers established by his study.

The chairman of the FDA advisory panel, Dr. William Hiatt, told 60 Minutes he would have voted to remove Trasylol from the market had he been informed about Bayer's study, according to the CBS report.

As acknowledged by company spokeswoman Meredith Fischer in the February 15 Reuters article, product liability lawsuits have been filed against Bayer on behalf of patients who had died or been seriously injured following the use of Trasylol during their heart surgery.

P.S.  In advance of the September 2006 advisory committee meeting about Trasylol, FDA reviewers asked Dr. Mangano for his group’s data in order to see if Trasylol should be withdrawn based on the new evidence.  Read what happened thereafter in Merrill Goozner's November 27, 2006 article, "CABG from NEJM on Thanksgiving", which he posted at Gooznews.com  (2/19/08)

Trasylol Sales In U.S. And Canada Suspended Temporarily By Bayer In Early November 2007

Market Withdrawal Or Recall Of Trasylol Seems Possible As Bayer Waits For Final Data From Halted BART Study

(Posted by Tom Lamb at DrugInjuryWatch.com)

On November 5, 2007 the FDA announced and Health Canada announced that sales of Bayer AG' s anti-bleeding drug Trasylol (aprotinin) would be suspended temporarily in the U.S. and Canada while investigations continued about whether Trayslol is linked to a higher risk of death than competing heart surgery drugs.

As we had reported previously, the FDA has been reviewing the safety of Trasylol since early 2006:

In mid-February 2006 the FDA issued a Public Health Advisory informing doctors and patients that the agency was evaluating the safety of Bayer AG's heart surgery drug Trasylol (aprotinin injection) after new studies had linked it to higher risks of kidney problems, heart attacks, and strokes.  At the end of February 2006, a "Dear Doctor" letter from Bayer regarding Trasylol was posted on Health Canada's MedEffect web site.

Later, in September 2006, an FDA advisory panel reviewed data from medical journals that suggested that Trasylol might increase the chance of kidney damage, heart attacks, and strokes.

A second Trayslol advisory panel meeting was scheduled for September 2007.  Two days before, FDA staff released 235 pages of briefing documents they had prepared for that Trasylol advisory panel meeting which seemingly foreshadowed this most recent development in the Trasylol saga.

From a September 10, 2007 Reuters article, "Bayer's Trasylol may boost death risk: FDA staff", by reporter Kim Dixon:

FDA staff, in briefing documents ahead of Wednesday's advisory panel, said the totality of three recent studies support the risk of renal failure and dysfunction, and noted a "mortality disadvantage detected" in the Bayer study.

A Bayer spokeswoman said the company looks forward to discussing the drug's merits at the advisory panel meeting....

"There is still no new clinical data, so the question is whether (Bayer's) observational study is enough of an alarm," said Ira Loss, an analyst at the investor research firm Washington Analysis.

"My assumption is this drug is being put into the dead-end of drug land," he added.

While the September 2007 Trasylol advisory panel decided this heart surgery drug should remain on the market despite its increased renal and cardiovascular risks, it urged Bayer to conduct a randomly controlled clinical trial on Trayslol.

Bad news for Bayer, however, soon followed when a Canadian study -- the BART study, an independent randomized, controlled trial that was being conducted in high-risk cardiac surgery patients -- was suddenly stopped in mid-October 2007 due to emerging serious safety concerns regarding Trayslol.

On October 25, 2007 the FDA posted on its web site an "Early Communication about an Ongoing Safety Review Aprotinin Injection (marketed as Trasylol)" which said, in part, stated that the 30-day mortality risk in the Trasylol group of the BART trial was nearing statistical significance, compared with other treatments Trasylol was being tested against.

A November 5, 2007 Reuters article about the suspension of Trayslol sales brings us up-to-date with this information:

• On [November 5, 2007] Bayer said it had been informed that BART trial data were now being collected from centers throughout Canada and final data analysis would emerge in around eight weeks.
• "Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol," Bayer said [November 5, 2007].
• "Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling," the company said.

We will wait to see whether or not the final analysis of this BART study data and any other relevant information leads to Bayer withdrawing Trasylol from the market altogether in the months to come.  Of course, it is possible that based on their findings the FDA or Health Canada may make that choice for the drug company.

FDA Updates Exjade Adverse Drug Reaction Numbers In Its First Drug-Safety Newsletter

FDA Post-Marketing Safety Review Adds Liver Problems To Previous Reports Of Kidney Failure Associated With Exjade

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the first edition of FDA Drug Safety Newsletter (Volume 1, Number 1), which was posted on the FDA's web site September 18, 2007, there is an article about the agency's post-marketing safety review of Exjade (deferasirox).  This medication is an orally active chelating agent that removes excess iron in patients undergoing regular blood transfusions. Marketed in the U.S. by Novartis AG (NVS), Exjade was approved by the FDA for sale in 1995.

Adverse drug reaction reports associated with Exjade were the subject of a May 22, 2007 article in The Wall Street Journal, "FDA Warns Novartis's Exjade Could Cause Kidney Failure", which included this information:

In a May 14 letter to health-care professionals posted Tuesday to the FDA's Web site, Novartis said it received reports of kidney failure, some with a fatal outcome, in postmarketing reports of Exjade....

In a statement, Novartis said there were eight deaths associated with acute renal, or kidney, failure. More than 13,000 patients have been treated with Exjade since the drug was approved in November 2005.

In mid-September 2007 the FDA updated us on the Exjade safety situation, stating in the FDA Drug Safety Newsletter that the agency had received 115 reports of suspected adverse drug reactions (ADR) in association with Exjade use, including 17 deaths in adults.

In more detail, the FDA provided this additional information about the Exjade ADR reports it received from November 2005 through June 20, 2006:

• 108 of the reported Exjade cases were considered serious, with 74 events requiring hospitalization;
• 24 of the Exjade reports involved liver problems and included three reports of liver failure; those patients, however, apparently had a history of liver problems;
• 16 reports concerning Exjade use were associated with kidney problems; and,
• 15 reports to the FDA were associated with Exjade causing various blood disorders.

In closing-out its September 2007 Exjade update article, the FDA said that additional studies are being conducted in order for the agency and Novartis to "determine the longer-term benefits and risks of [Exjade (deferasirox)]."

Of course, we will continue to monitor and report on the safety profile of Exjade.

Natrecor Is Associated With Increased Risk Of Acute Renal Failure And Death

Questions About Safety Of Natrecor Continue, With No Apparent Resolution Any Time Soon

(Posted by Tom Lamb at DrugInjuryWatch.com)

As reported previously, in June 2007 Scios, Inc. announced it had started enrolling patients in a 7,000-patient trial designed to "assess the long-term clinical outcomes and benefit/risk profile of Natrecor (nesiritide) in patients with acutely decompensated heart failure (ADHF)".  At the time, Scios did not mention when this Natrecor safety trial would be completed nor when its results would be available.

As background, the safety profile of Natrecor has been a matter of much debate since a prominent heart doctor, Dr. Jonathan Sackner-Bernstein, published two reports in 2005 warning that Natrecor use was possibly linked to significantly increased rates of kidney problems and death.

Over time, we have monitored developments regarding the safety of Natrecor, including these two reports among other:

Natrecor: Is Controversial J&J Heart Failure Drug Harmful Or Harmless?

Natrecor Safety Controversy Considered In Two May 2007 Medical Journal Articles

While we wait to learn the results of the large-scale Natrecor trial which started-up in June 2007 -- and finally find out whether or not Natrecor is associated with an increased risk of serious kidney problems which could be fatal -- we consider a couple more medical journal articles about the safety of Natrecor.

The first article, "Benefit-risk assessment of nesiritide in the treatment of acute decompensated heart failure", was published by Drug Safety in January 2007 but only recently came to our attention.  Based on research done by the Baylor Heart and Vascular Institute, Baylor University Medical Center, in Dallas, Texas, we get the following information from the Medline Abstract for this January 2007 Natrecor article:

The effect of nesiritide on all-cause mortality is currently unresolved. Recent meta-analyses of existing databases have raised concerns regarding adverse effects of the drug on 30-day mortality. However, reviews of large, observational, registry databases do not suggest an adverse inpatient mortality effect compared with other vasodilator therapies. Further resolution of the mortality question awaits completion of pending randomised controlled clinical trials.When used for approved indications and according to recommended dosage and administration regimens, nesiritide represents a reasonable treatment adjunct for ADHF.

A more recent article, published online on September 5, 2007, from Nephrology Dialysis Transplantation, is "Predictors of mortality in adult patients with congestive heart failure receiving nesiritide—Retrospective analysis showing a potential adverse interaction between neseritide [sic] and acute renal dysfunction".  Drawing from the Abstract for this the Abstract for this September 2007 Natrecor article:

• Univariate analysis revealed that Natrecor usage was associated with increased mortality
• However, Natrecor usage was not an independent predictor of mortality.
• When patients were stratified according to Natrecor usage, acute renal failure emerged as an independent risk factor for mortality only among patients who received Natrecor.
• Among congestive heart failure patients who developed acute renal failure, Natrecor usage emerged as the only independent predictor of mortality.

In turn, these findings led the authors to this Conclusion:

We conclude that, while [Natrecor] per se is not independently associated with an increased risk for mortality, the development of [acute renal failure] in association with [Natrecor] use may confer an increased risk of mortality.

We will continue to report on developments regarding this Natrecor drug-safety issue.

Safety Of Trasylol Will Be Reviewed By FDA Advisory Panel In September 2007

Will Consider Data Suggesting Trasylol Can Cause Kidney Damage, Heart Failure, and Death

(Posted by Tom Lamb at DrugInjuryWatch.com)

An August 22, 2007 article, "FDA panel will review Trasylol safety", published in the The Boston Globe informed that the FDA will convene an advisory committee of drug safety experts on September 12, 2007 to discuss Bayer AG's blood-clotting drug Trasylol. 

The safety profile of Trasylol has been under FDA scrutiny for more than a year due to case reports which indicate that Trasylol may be associated with kidney damage and heart failure, including some patient deaths. Trasylol is used to reduce blood loss during coronary artery bypass surgery.

In fact, the FDA held a similar advisory committee meeting in September 2006.  Thereafter, the FDA required Bayer to add safety warnings to the Trasylol package insert, or label, in late 2006 stating that doctors should only use Trasylol in patients who have an elevated risk of blood loss during surgery.

The FDA advisory committee that is scheduled to meet in September 2007 could recommend more restrictions on when and how Trasylol should be used.

A side story regarding the September 2006 Trasylol advisory committee meeting developed when, following that meeting, Bayer said two employees had withheld some additional information about Trasylol side effects from that the evidence which was presented by the drug company at that meeting. Coincidentally, or ironically, Bayer announced just last week that an outside investigation had concluded these two employees did not intend to mislead the FDA's earlier advisory committee members by withholding that Trasylol side effect information.

Long-Awaited Natrecor Trial Starts To Enroll Patients In June 2007

Scios Inc. Finally Going To Assess Benefit / Risk Profile Of Natrecor In Large Trial Of Patients With Acutely Decompensated Heart Failure

On June 8, 2007 Scios, Inc. let the public know that it has started enrolling patients in a 7,000-patient trial designed to "assess the long-term clinical outcomes and benefit/risk profile of Natrecor (nesiritide) in patients with acutely decompensated heart failure (ADHF)".

According to this June 8 announcement by Scios on the Johnson & Johnson (J&J) web site, Natrecor has previously only been studied in "16 prospective clinical trials involving 2,012 patients", while it has been used to treat "more than 800,000" patients with ADHF since it was approved in 2001.

As background, in June 2005 asked a prominent cardiologist, Eugene Braunwald of Harvard, to convene an advisory panel of heart doctors in order to assess analyses published by two leading medical journals that raised new safety questions regarding Natrecor. Those analyses pooled data from selected tests of Natrecor and estimated the drug may increase the risk of compromised kidney failure by 50%, and of death within 30 days by 74% or more, compared with other therapies.  Soon thereafter, Dr. Braunwald's panel urged J&J and Scios to proceed with a follow-up study to investigate the safety profile of Natrecor.

About a year later, in May 2006 one of the members of that Braunwald panel, Dr. Milton Packer, criticized J&J and Scios for their delay in doing the definitive study that the panel recommended in the summer of 2005.

Now, in the summer of 2007, we learn from J&J and Scios that they are starting to enroll the first patients in this long-awaited Natrecor safety trial.

The June 2007 announcement by J&J and Scios provides these details about this new trial, called Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure, or ASCEND-HF:

In this randomized, double-blind, placebo-controlled, parallel-group, multi-center outcomes trial, approximately 7,000 patients with ADHF will be randomized to receive placebo or NATRECOR® for a minimum of 24 hours up to a maximum of seven days, in addition to standard care.

The primary objective of the trial is to assess whether treatment with NATRECOR® in addition to standard care, compared with placebo plus standard care, improves patient outcomes, as measured by reduction in the composite of heart failure rehospitalization and all-cause mortality through 30 days; or improves heart failure symptoms, as measured by a patient self-assessed dyspnea, or shortness of breath, scale at six and 24 hours after NATRECOR® initiation.

The ASCEND-HF Natrecor trial is being conducted by the Duke Clinical Research Institute (DCRI), which is working in collaboration with the Cleveland Clinic Cardiovascular Coordinating Center (C5).

There was no mention in the June 2007 announcement about when this Natrecor safety trial would be completed nor when its results can be expected.

Natrecor Safety Controversy Considered In Two May 2007 Medical Journal Articles

Is Natrecor An Example Of Why Dr. Steven Nissen Thinks That The FDA Is Dysfunctional And In Need Of Reform?

(Posted by Tom Lamb at DrugInjuryWatch.com)

Natrecor (nesiritide) is approved for the treatment of patients with acutely decompensated heart failure who suffer from symptoms at rest or with minimal exertion. 

In the past couple of years there have been serious concerns, however, about whether Natrecor causes excess mortality and worsening renal insufficiency.  In short, the issue is whether the benefits of Natrecor outweigh the associated risks.

The May 2007 edition of Current Radiology Reports includes two articles of interest to those of us who are following this issue of drug safety for Natrecor.

The first article, "Nesiritide for acute decompensated heart failure: does the benefit justify the risk?", is co-authored by Jonathan Sackner-Bernstein, M.D., of Clinilabs, Inc. in New York.  Dr. Sackner-Bernstein is a long-standing critic of Natrecor, and has consistently argued that more testing of Natrecor is necessary.  In this article Dr. Sackner-Bernstein reiterates that position, as seen in the free Abstract available online:

[Natrecor's] approval was based on a clinical development program that focused on surrogates and short-term effects on symptoms rather than clinical outcomes. The association between its use and subsequent risk of death raises the question of whether the endpoints assessed in the clinical development program were adequate, and provides the opportunity to evaluate the process of weighing risks with benefits. We conclude that with nesiritide, the risks of therapy outweigh the benefits demonstrated to date.

The second article, "Safety and efficacy of nesiritide for acute decompensated heart failure: recent literature and upcoming trials", examines the background of the ongoing controversy about the safety of Natrecor and looks forward to the future clinical trials that are intended to resolve the risk-benefit issue for this heart-failure drug.  From the free online Abstract for this article:

We review the recent evidence regarding the efficacy and safety profile of nesiritide, and discuss upcoming trials designed to address concerns regarding safety and the comparative efficacy of nesiritide. 

Finally, the same May 2007 edition of Current Cardiology Reports has a commentary by this medical journal's editor-in-chief, Steven E. Nissen, M.D.  His piece is entitled "The US Food and Drug Administration: A Dysfunctional Agency in Need of Major Reforms". Unfortunately for us there is no free Abstract available for this item.

Heart Failure Drug Natrecor Fails Efficacy Part Of "Off-label" Use Study

Safety Profile Of Natrecor Continues To Be Subject Of Controversy And Debate

(Posted by Tom Lamb at DrugInjuryWatch.com)

The results of a large study for Johnson & Johnson's heart failure drug Natrecor failed to prove that its out-patient use in people with severe disease in addition to the current standard treatment regimen was any more beneficial than the standard treatment alone.

According to a March 25, 2007 Reuters article about this Natrecor study:

The company-sponsored, 920-patient trial fell short of its primary goal of showing the drug, Natrecor, could reduce the risk of death or heart and kidney-related hospitalizations. Results were presented on Sunday at an American College of Cardiology meeting in New Orleans.

The trial failed to find a difference between a group of patients getting standard treatment and those getting standard treatment plus Natrecor, known generically as nesiritide and given by infusion....

"The take-home message is, giving (Natrecor) intermittently did not reduce patients' risk of death or hospitalization. The strategy didn't work," said Steven Nissen, chief of cardiology at the Cleveland Clinic and president of the American College of Cardiology.

Natrecor is sold by the Johnson & Johnson subsidiary Scios.  Natrecor is approved to treat patients with heart failure serious enough to have them admitted to a hospital.  In recent years there has been growing concern about its "off-label, or unapproved, use in patients outside the hospital, i.e., out-patient setting.  In addition, several studies have suggested that Natrecor may actually increase the risk of death and worsen kidney function.

There was some debate about whether this recent study did anything to alleviate those concerns about the safety profile of Natrecor.  From the March 25 Reuters article:

The study also found no difference in severe side effects between both patient groups. The drug's supporters hope that result will allay safety concerns among doctors about its use....

...Scios vice president for medical affairs Roger Mills said the study should reassure doctors who cut back on the drug's use when the negative studies came to light several years ago.

"There is no hint of a problem with renal function or mortality. I think for the most part physicians should find these data very reassuring," Mills said.

But doctors on a panel discussing the study disputed the claim that the drug can be declared safe as a result of the study, noting there were more drug-related side effects in the Natrecor group. And there was a trend toward more days alive outside the hospital in the placebo group.

"I'm a little perplexed about your conclusions that this drug is safe," one panel member said.

In response to inquiries about the results of this Natrecor study, Scios said it had not decided, yet, whether the company will continue to test the efficacy and safety of Natrecor use in any out-patient setting.

Natrecor: Is Controversial J&J Heart Failure Drug Harmful Or Harmless?

Scios Announces Study To Address Safety Issues But Results Not Expected For Several Years

In the October 1, 2006 issue of the medical journal Pharmacotherapy is an article which emphasizes the need to resolve the safety issues surrounding the heart failure drug Natrecor (nesiritide).  The Medline abstract for "Nesiritide: harmful or harmless?", by MP Dorsch and JE Rodgers, succinctly sets forth the current situation:

Recently, two meta-analyses raised the question of safety with [Natrecor] therapy, specifically an increased risk of renal dysfunction and mortality. Although several studies generated information regarding the potential role of [Natrecor] in various settings, the questions raised by the meta-analyses are concerning. Our hope is that future clinical trials will address the concerns raised and provide a better understanding of the role of [Natrecor] in the management of acute decompensated heart failure. Until these data are available, [Natrecor] use should be limited.

As for those two recent studies, Dr. Keith Aaronson, of the University of Michigan, and Dr. Jonathan Sackner-Bernstein, of the New York research firm Clinilabs, re-examined data from two previous clinical trials involving heart drug Natrecor.  Their analysis, set forth in the September 26, 2006 edition of the Journal of the American Medical Association, led Aaronson and Sackner-Bernstein to conclude that Natrecor is associated with a significant increased risk of death.  According to a September 29 report in the Contra Costa Times, Dr. Sackner-Bernstein reached this conclusion: "There appears to be a very strong association between the use of nesiritide and the risk of death within 30 days".

In the same newspaper article, a spokesperson for Scios -- a unit of the drug company Johnson & Johnson (J&J), which is responsible for Natrecor -- took issue with the assertion by Aaronson and Sackner-Bernstein that there is an increased risk of early mortality in patients who used Natrecor at recommended starting doses.

Coincidentally, earlier in September 2006 Johnson & Johnson had announced the favorable results of a Scios-sponsored study which looked at Natrecor use in 279 heart failure patients who underwent heart bypass surgery.  But according to a September 11, 2006 Reuters article, one of the investigators for the Scios study, cardiac surgeon Dr. John Luber, said these results had to be viewed in context.  Reuters quoted Dr. Luber as stating "I do not think it is absolute vindication, but I do think it is a light a the end of the tunnel."  The Reuters article continued:

[Dr. Luber] said a larger study will be needed to test what patients might best benefit from [Natrecor].... 

An independent expert panel had recommended a wider study to evaluate the safety of the drug more than a year ago.

Last week, Scios said it named Duke Clinical Research Institute as the independent research organization that will lead the trial, which the company said will start in the second half of 2007.

In more detail, Robert M. Califf, director of the Duke Clinical Research Institute at Duke University in North Carolina, will lead a Scios-sponsored clinical trial intended to test the safety and efficacy of Natrecor.  This announcement came more than 15 months after the call for a study to investigate the issue of whether Natrecor increases the risk of death or kidney failure within 30 days of treatment among patients hospitalized with acute heart failure.  According to a September 8, 2006 article in The Wall Street Journal:

The study, whose precise design has yet to be finalized, is expected to first evaluate safety and efficacy at 30 days after treatment. Enrollment of patients -- about half from North America and the rest from elsewhere around the world -- is expected to begin in the first half of next year. Dr. Califf said the first results should be ready in two to three years.

Until the safety issues are resolved, as advised by Dorsch and Rodgers in their article "Nesiritide: harmful or harmless?", it seems that the use of Natrecor should be limited.

(Posted by: Tom Lamb)

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)