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Zyvox -- Drug Prescription With Hidden Revelation

 

Reference To Karl Loren Article

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The drug described on this page was prescribed for Jean on the day she left the hospital.  There was no special warning or explanation about this drug -- it was "just" one of three different antibiotics the hospital gave us -- to get the prescriptions filled at our own expense at our local pharmacy.  Generally the stay at the hospital included her major surgery to remove her esophagus and the biopsy findings of no cancer!  That was the good news.  There was, however, some very poorly practiced medicine at that same hospital -- not by our doctor, but nonetheless it certainly seems to rise to the standard of "medical malpractice" that could have resulted in Jean's death.  This is the page that describes that situation.

[Note:  I sent a FAX to the surgeon about my concerns for the cost of this drug, and its use, and even though it was a Saturday, she was in her office, called us, and when she realized the cost, she said that we should just skip this drug.  She rather indicated that it was just an "extra" source of antibiotic help."  She certainly did not describe some specific type of bacteria which was resistant to all other forms of antibiotic, and therefore justify the use of this one.  It is also certainly true that she had prescribed two OTHER antibiotics which are rather common.]

The manufacturer of this drug, however, says the following:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX and other antibacterial drugs, ZYVOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.  (Source)

When I found that ONE of these three antibiotics cost $1,500 for the amount prescribed, and that it could only be obtained by special order -- three day delay for receipt -- I went looking, doing my usual research.  What I found disturbed me and I have recounted these findings on THIS page.


This drug was prescribed for Jean as she left the hospital after her surgery for removal of the esophagus.  When I went to obtain the drug, by the prescription I had received at the hospital, I found that the dosage I was supposed to get cost $1,500, and could not be obtained except by special order (three days).  So, I decided to do more research on it.

When I got the prescription at the hospital, the nurse also gave me a printed information sheet from a source called "Micromedex Healthcare Service" which described this drug which said, simply, "Treats bacterial infections.  This medicine is an antibiotic."

I found many references to this drug on the web, including so-called "cheap" versions at about $1,200 for the same quantity that my local drug store would have charged $1,500.

I found many references to the various uses for this drug.  They seemed rather straightforward to me -- the drug was used for special types of infection where the infection had proven to be resistant to the normal antibiotics.

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Then I looked at the information provided about this drug by the FDA, and found the information published below -- this is the official FDA information about this drug.  Click here to jump to that reference on this page.

The FDA information included some startling data that I found no where else -- and made me wonder about an apparent deliberate effort to hide this information.

In other words, the FDA information, prominent in mention, suggests that this is a drug used to treat "hospital-acquired infections."  "What does this mean," I asked myself.  "Could Jean have acquired some infection IN THE HOSPITAL that is so resistant to other antibiotics that only this very expensive drug would work?"

And, said I to myself, "Is the hospital giving me an 'information sheet' about this drug which deliberately omits this stunning information?"  And, further, "Are all the dozens of pages on the web ALSO omitting this stunning information that, perhaps, the drug is needed particularly to treat 'infections acquired in a hospital'?"

And, I couldn't help thinking that, "The number four cause of death in the United States is drugs improperly given in hospitals!!!Click here for that full story.

The authors analyzed 39 studies of hospital patients from 1966 to 1996. Serious drug reactions affected 6.7% of patients overall and fatal drug reactions 0.32%, the authors reported in Wednesday's Journal of the American Medical Association.

In the study, serious injury was defined as being hospitalized, having to extend a hospital stay or suffering permanent disability.

The most surprising result was the large number of deaths, the authors said. They found adverse drug reactions ranked between fourth and sixth among leading causes of death, depending on whether they used their most conservative or most liberal estimate.  (Source)

and

JAMA. 1998;279:1200 and 1216

COMMENT: There is NO QUESTION that this is the biggest medical story this week. Even I am shocked on this one. It is hard to believe that JAMA actually published this information. If you go into the hospital, there is a one in 15 chance that you will have an adverse reaction to a drug. Those are quite high numbers. Even more startling is that there is a one in 312 chance that the adverse reaction will result in death. This is such a high number that it is the FIFTH leading cause of death in this country. It is important to remember that this analysis was only done for hospitalized patients. The number is clearly higher as many more prescriptions are written for patients outside of the hospital. No, this does not mean one should never enter the hospital or never use drugs. I am very grateful that those resources exist and there are clearly times when they are necessary. However, it is important to try every last natural therapy before you resort to drugs or hospitalization.   (net source)

 

Was I on to something?

I think so!

Was there an "error" at the hospital which caused Jean to get an infection which was so resistant to other antibiotics that this very new, and extremely expensive antibiotic might be required?

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You be the judge.  Here is what happened.

Jean had a swallowing test, described here, in July 2004. There was no question of "posture" for this test -- Jean stood upright for the test.

However, after the surgery the surgeon told Jean that she should not, ever again, eat or drink while lying in bed, or in a prone posture.  In fact, she told Jean that Jean should always eat while sitting up, straight, in a chair.  Then, further, Jean should not go to bed, or lie flat, for about an hour.

Nonetheless, when we went to the room for the swallowing test the technician there asked Jean to get on the table for the X-Ray.  We could see two different types of X-Ray arrangements -- one was next to a "chair" that someone could sit in during the test.  The "table" was apparently only for getting tested while the body was flat, or slightly inclined.

When the doctor arrived to do the actual test, Jean protested that she had been told by her surgeon to never swallow anything while lying flat.  I'm not sure what the doctor said, but he basically ignored this data and insisted that Jean continue to lie flat on the table.

Jean did.  She won't do this again.

So, Jean did the swallowing test while lying flat, and the doctor mentioned that she "aspirated" == which means that some of the liquid went down into her lungs -- that causes pneumonia, and could cause death.

The surgeon did not criticize that doctor, but has rescheduled another swallow test (the right away).

 


Source

FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

 


 

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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

 



FDA APPROVES ZYVOX, THE FIRST
ANTIMICROBIAL DRUG IN A NEW CLASS

FDA today approved Zyvox (linezolid), the first antibacterial drug in a new class to treat infections associated with vancomycin-resistant Enterococcus faecium (VREF), including cases with bloodstream infection. Zyvox also received approval for treatment of hospital-acquired pneumonia and complicated skin and skin structure infections, including cases due to methicillin-resistant Staphylococcus aureus (MRSA). In addition, approval was granted for treatment of community-acquired pneumonia and uncomplicated skin and skin structure infections. The following may be used to respond to questions.

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Infections due to Enterococcus faecium and MRSA are a particular problem in hospitalized or immunocompromised individuals. These organisms are often resistant to multiple antibiotics. Vancomycin has, for many years, served as the treatment of last resort for these infections. In 1989, the first case of vancomycin-resistant Enterococcus faecium (VREF) was reported in this country. Since then, there has been a rapid increase in the incidence of VREF infections, as well as a dramatic increase in the incidence of MRSA infections. There have been limited therapeutic options available for patients with these infections.

Zyvox is the first in a new class of synthetic drugs -- the oxazolidinone class -- approved for use in the United States and the world. It is also the first drug in over 40 years to be introduced into the US market for treatment of MRSA infections.

Zyvox's approval was supported by controlled clinical trials that enrolled more than 4000 patients. The approval for VREF infections was based on a dose-comparison study in which 145 patients were treated with Zyvox (600 mg or 200 mg) every 12 hours for VREF infection. Types of VREF infections studied included complicated intra-abdominal infections, complicated skin and skin structure infections, urinary tract infections, and bacteremia of unknown origin. The cure rate for Zyvox was 67 percent in the high-dose arm and 52 percent in the low-dose arm.

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Zyvox was also found to be as effective as vancomycin for treatment of hospital-acquired pneumonia, including cases due to MRSA, in a controlled clinical trial involving about 400 patients. The approval for complicated skin and soft tissue infections, including those caused by MRSA, was based on a controlled clinical trial of approximately 800 patients comparing linezolid with oxacillin/dicloxacillin. Additional information on the use of linezolid in the treatment of cases of hospital-acquired pneumonia and skin and skin structure infection caused by MRSA came from a supportive study comparing linezolid to vancomycin.

The most frequently reported side effects attributed to Zyvox in the clinical studies were headache, nausea, diarrhea, and vomiting. The most important laboratory test change was a decrease in platelet counts.

Zyvox may interact with certain other drugs, including over-the-counter cold remedies that contain pseudoephedrine or phenylpropanolamine, and cause an increase in blood pressure. Patients receiving Zyvox should inform their physicians if they are taking such medications.

Pharmacia and Upjohn, the drug's manufacturer, anticipates that therapy with Zyvox will be initiated principally in the hospital or institutional care setting. Due to concerns about inappropriate use of antibiotics leading to an increase in resistant organisms, prescribers should carefully consider alternatives before initiating treatment with Zyvox in the outpatient setting.

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FDA's approval follows the recommendations of the Anti-Infective Drugs Advisory Committee. Their recommendation for approval of these indications was based on the results of clinical studies presented at a meeting of the Committee on March 24, 2000.

Pharmacia and Upjohn, based in Kalamazoo, Mich., developed Zyvox and will market it in the United States.

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