If you have
read the flox report, you know that we believe that it is proven beyond any
doubt that:
Fluoroquinolones have an extreme toxicity
that results in a very high rate of side effects
Everybody gets damaged even if
he/she does not feel any symptom initially.
However,
some doctors that visit our page get shocked basically because they think that
the flox report is a compilation of very rare cases, laid in such a way that might
people sway the way they see fluoroquinolones, and therefore make them prone to
take wrong decisions concerning their health.
The problem
of these doctors is that they do not have enough information, therefore their
knowledge is reduced, and it is them who put at risk the health of their
patients misprescribing fluoroquinolones.
Look at
this excerpt:
The first reports
of an association between fluoroquinolone antibiotics and tendonitis came from
There have been many since and by 1994 the FDA had received 25 reports
of tendon rupture. Seventeen of these were of Achilles tendons but shoulder and
hand tendon rupture was also described. The age range was 33-85 years, and the
tendon ruptures occurred at therapeutic doses at a range of two to 42 days
after first dose. Of these 25 cases, 14 were also taking steroids and four
occurred in people of advanced years, but in nine there were no other risk
factors.
Appropriately for a tendon problem, a prospective ultrasound study was
conducted at the Hospital Universitaire Dupuytren [
The ultrasound features were of hypoechogenicity (50 per cent),
peri-tendous effusion (28 per cent) and tendon thickening (22 per cent). For a
volunteer study in healthy controls, no ruptures occurred.
The mechanism by which fluoro-quinolone antibiotics cause this problem
is not clear. In animal studies, they can cause arthropathy. There is evidence
of collagen depletion and disruption of the extracellular matrix. The
antibiotics in this class available in
The
conclusions are almost obvious. When half of the treatment had been completed,
61% had injuries in their tendons, whereas all of them were healthy before. But
only 7% were symptomatic. We can guess easily that probably by the end of the
treatment, all volunteers had injured their tendons. This experiment shows that
our estimations of adverse rate effects are much more accurate than the
official ones.
The above
report was conducted by a public european universitary
hospital, that are funded with public money. But compare it with this other
report, edited by a manufacturer of a fluoroquinolone:
Johnson & Johnson Pharmaceutical
Research & Development, L.L.C.,
Objective: To probe the pharmacokinetic basis for the use of
levofloxacin for complicated skin and skin-structure infections (SSSIs) at a
once-daily dosage of 750 mg by investigating its penetration into skin tissue.
Method: Ten healthy
volunteers were administered three oral, once-daily 750 mg doses of
levofloxacin, and levofloxacin concentrations were subsequently measured over
time (0.5-24 h) in skin-punch biopsy tissue and plasma. Results: Skin tissue concentrations
consistently exceeded those in plasma at every time point, with tissue/plasma
ratios of 1.37 +/- 0.81 for peak concentration and 1.97 +/- 0.35 for area under
the concentration versus time curve. Three of the ten subjects reported
treatment-emergent adverse events that were considered unrelated to treatment.
An 11th subject who had enrolled in the study withdrew after adverse events of
mild severity that were possibly related to the study drug. Conclusion: The
results support the clinical usage of levofloxacin 750 mg once-daily for
complicated SSSIs.
Look
carefully. Four out of then HEALTHY volunteers suffered side
effects, but three, being healthy as they were just happened to have adverse
reactions during those days of the trial. Surely they showed some or
many of the side effects listed on the PART IV of the flox-report: "Symptoms
of being intoxicated by a fluoroquinolone", but as the manufacturer does
not acknowledge them, they were classified as not related to the drug. Period. An easy way of dropping a figure
from 40% of side effects to 10% in that trial. Nevertheless, the dose of
levofloxacin used is high enough to cause a 100% of side effects after 10 days
or more. If the researchers of Johnson &Johnson had made an ultrasound of
the achilles tendons of the volunteers, they would have seen that all showed
injuries and abnormalities, so the conclusion could have never been "The results support the clinical usage of levofloxacin
750 mg once-daily for complicated SSSIs." , but rather different, perhaps this: "The results recommend to extreme
care during clinical usage of levofloxacin 750 mg once-daily for complicated
SSSIs because a 100% of side effects ocurrence was observed".
Do you want
to see yet another method of manipulating the ratios of side effects?. No problem, there are hundreds of such reports, and here
we include just one randomly selected:
Levofloxacin 750 mg QD for five days versus amoxicillin/clavulanate 875
mg/125 mg BID for ten days for treatment of acute bacterial exacerbation of
chronic bronchitis: a post hoc analysis of data from severely ill patients
Grossman RF, Ambrusz ME, Fisher AC, Khashab MM, Kahn JB.
This post hoc analysis of data from a previous randomized, blinded,
multicenter, parallel, noninferiority study assessed the bacterial etiology,
symptom resolution, and tolerability of severe acute bacterial exacerbation of
chronic bronchitis (ABECB) patients treated with either levofloxacin 750 mg QD
for 5 days or amoxicillin/clavulanate 875 mg/125 mg BID for 10 days. Severe
ABECB was defined as ABECB and forced expiratory volume in 1 second (FEV(1)) <50% of the predicted value, or (FEV(1)) of 50%
to 65% of the predicted value plus comorbidities, or > or =4 exacerbations
per year. A total of 369 patients were included in the intent-to-treat (ITT)
population (187 treated with levofloxacin and 182 treated with amoxicillin/clavulanate),
and 175 patients were microbiologically assessable (MA) (86 treated with
levofloxacin and 89 treated with amoxicillin/clavulanate). In the ITT
population, the mean age was 58.7 years, 49.1 % were male, and 48.2% were
current smokers. At the on-treatment visit, a significantly higher proportion
of MA patients in the levofloxacin group resolved purulent sputum production
(57.5% vs 35.6%; P < 0.006), sputum production (65.4% vs 45.3%; P <
0.013), and cough (60.0% vs 44.0%; P < 0.045), compared with the
amoxicillin/clavulanate group. However, no significant between-group
differences were observed at posttreatment. A total of 341 pathogens were
isolated, of which 143 (41.9%) were traditional ABECB flora, 181 (53.1%) were
other gram-negative organisms, and 17 (5.0%) were gram-positive organisms.
Overall susceptibility of the pathogens was 97.1% for levofloxacin and 90.6%
for amoxicillin/clavulanate (P < 0.001). The prevalence of
treatment-emergent adverse events was 42.1 % in patients who received
levofloxacin and 48.6 % in those who received amoxicillin/clavulanate (95%
CI,-4.0 to 17.0).
These
researchers put conclusions in such a way so that we all tend to think that only
42% of the patients taking levaquin suffered side effects, compared with 48% of
those that took amoxicillin-clavulanate. So, any doctor and patient alike would
probably choose levaquin trying to lower their chances of getting injured. Researchers
intentionally never discern among severity of side effects. Setting aside the hypersensivity
and allergy cases, we all know which are the main side
effects of both antibiotics:
LEVAQUIN: mainly guaranteed
structural, long term injuries to all tendons of the body; irreversible
neuropathies, brain injuries, mental disorders, eye lesions, heart
abnormalities, endocrine (hormonal) impairement, skin cancer if exposed to
sunlight, osteoarthritis, sjögren's, rheumatic reactions, ....... that last for
years or forever
AMOXICILLIN-CLAVULANIC: mainly
diarrhea, stomachal upset, ......... that dissapear
short after ending the treatment.
In any
case, any doctor that bears doubts about the innocuosity of fluoroquinolones
and feels threatened his/her medical practice, might consider contacting
colleage Marc Siegel and ask him for a reassurance:
Marc Siegel, M.D. (circa
2006)
"Quinolones are great drugs, but like all great drugs, they should
be
used judiciously. All drugs have side effects, and this family of
antibiotics is no exception, causing occasional diarrhea, insomnia,
tremors and restlessness. There is also righteous concern about
quinolone use in children because of potential problems with growing
bones. But criticism of the risks associated with these drugs has
been overblown...Criticism against quinolones has obscured a safe,
versatile and extremely useful category of drugs."
Marc Siegel is an internist and associate professor of medicine at
Professor at the New York University School of Medicine and a fellow
in the Master Scholars Society at
a weekly columnist for The New York Daily News, frequent contributor
to the New York Times, Los Angeles Times and Washington Post, and a
member of the board of contributors at USA Today. Dr. Siegel is a
syndicated columnist for Tribune Media Services. Dr. Siegel appears
regularly on CNN, the NBC Today Show, and the Fox News Channel.
Remember:
fluoroquinolones are great drugs, and the side effects are occasional diarrhea,
insomnia, tremors and restlessness. Marc Siegel, dixit. Illiteracy
on quinolones in pure state. One always wonders how dangerous,
and irresponsible persons get high positions with great influence on the
society.
Our proposal
for the real side effects ratios of fluoroquinolone treatments, compared with
the official figures is this one:
|
ADVERSE EFFECTS OCCURRENCE FOR FLUOROQUINOLONE
ANTIBIOTICS (Using ciprofloxacin potency as
reference). (People of up to |
||||||
|
THERAPEUTIC REGIME / DOSAGE |
PERCENTAGE
OF ADVERSE EFFECTS |
DURATION OF THE ADVERSE EFFECTS (according to us) |
||||
|
According
to manufac-turers |
According
to us |
|||||
|
Considering
hidden injuries |
Considering
only very noticeable symmptoms by the patient |
|||||
|
SEVERE reaction |
INTER-MEDIATE reaction |
MILD reaction |
||||
|
short treatments of low doses (example 1 week of 250
mg/day) |
less than 5% |
?? |
0% |
0% |
10% |
A few weeks |
|
up to one week of up to 1,000 mg daily |
less than 5% |
50% |
7% |
18% |
25% |
Several weeks to months |
|
6 weeks of 1.000 mg daily |
less than 5% |
100% |
58% |
86% |
100% |
Months to years |
|
more than 6 weeks on a 1,000 mg/day basis |
less than 5% |
100% |
76% |
91% |
100% |
Mean duration of severe limitations and pains for
2.5 years, but can be 6 years more - and in some cases the damage and
destruction is permanent or ends in death. |
|
1,500 mg/day for a week or more |
less than 5% |
100% |
92% |
100% |
100% |
Many years or permanent |
|
For the interpretation of what is a SEVERE,
INTERMEDIATE or MILD reaction, consult further in the report. |
||||||
"Considering
hidden injuries" means that if all persons that took fluoroquinolones were
properly screened (for example, doing a biopsy of any tissue, or simply doing
an ultrasound of ANY of their tendons), the real rates of side effects would be
these ones.