PART I:
INTRODUCTION
2.INTRODUCTION
Tens of thousands of people are
damaged by quinolone (Cipro, Levaquin, Floxin, Noroxin, etc.) antibiotics each
year, yet nearly all those damaged remain undiagnosed or misdiagnosed. Some are
diagnosed as having fibromyalgia, lupus, lyme disease, multiple sclerosis,
rheumatoid diseases, myositis, diverse heart problems or neuropathies of every
kind. Thousands of people become severely crippled for years, or even
permanently, after taking a quinolone antibiotic for minor infections.
Quinolone antibiotics are toxic
from the very first milligram of ingestion. The effects of quinolone
antibiotics are cumulative. Each person has a unique threshold of tolerance for
the quinolones that once surpassed releases symptoms corresponding to various
disorders, with long-lasting and potentially permanent damage. People are
exposed to quinolones through taking them as a drug prescription or through
food (chemically treated poultry and cattle).
|
NEW TEXTS ON THE PACKAGE INSERTS OF
FLUOROQUINOLONES: << Peripheral neuropathy: Rare cases of
sensory or sensorimotor axonal polyneuropathy affecting small and/or large
axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have
been reported in patients receiving quinolones, including ciprofloxacin.
Ciprofloxacin should be discontinued if the patient experiences symptoms of
neuropathy including pain, burning, tingling, numbness, and/or weakness, or
is found to have deficits in light touch, pain, temperature, position sense,
vibratory sensation, and/or motor strength in order to prevent the
development of an irreversible condition >> |
Only a handful of doctors are
aware of this devastating problem. The rest are uninformed, at least in
technical matters, by the manufacturers. The drug manufacturers conceal the
real toxic profile of the fluoroquinolone antibiotics. The manufacturers know
they cause extensive damage, destroy lives and impair people for life, but they
manipulate the trials, especially in not conducting any long-term follow up
studies and under-reporting the adverse events. It is typical for manufacturers
to state as "very rare adverse
events found in less than 1% of cases", for adverse effects that have
a real percentage above 70% for therapeutic doses.
Manufacturers have found a
brilliantly disguised drug that in many cases wreaks havoc on its users some
weeks or months after cessation of the drug therapy, or through food ingestion,
making it almost impossible to trace back the symptoms to the real cause.
Recently (fall 2004), it has been
made mandatory that the package inserts of the quinolone antibiotics must
include a warning about “rare”
adverse reactions that can cause irreversible neuropathic conditions. Up to now
the possibility was simply systematically denied by the manufacturers because
admitting it could harm their revenue. The Food and Drug Administration (FDA)
also rejected any link between the thousands of individual reports on
long-lasting and permanent damage caused by quinolones because their policy
with respect to already marketed drugs is to delay as much as possible any
warning that could alarm the people and show the inefficacy of the procedures
and surveillance methods that they set to theoretically protect us.
Now, the overwhelming evidence
has forced manufacturers and the FDA alike to admit irreversible damage. We had
warned of it early in 2003, and many other groups of people and doctors are
reporting such cases for at least the past 20 years. Now they try to avoid the
sheer responsibility of indefinitely prolonging such a public health tragedy--
rating it as “rare”. It is only a
matter of time before they will have to admit that the extensive toxicity of quinolones
is a class effect of this type of antibiotic, and that it affects everyone
taking them, and that these drugs should be restricted to very special cases of
antimicrobial therapy.
Of special interest for athletes is the fact that quinolone and fluoroquinolone
antibiotics cause many problems concerning the musculoskeletal system, most of
which resemble other ailments that are acceptably known, diagnosed and treated
(epycondilitis, shin splints, plantar fascitis, overuse syndromes, trochanteric
bursitis, all sorts of tendinitis, tenosynovitis and enthesitis, ulnar
compression neuritis, ileotibial band syndrome, and many more). But the damage
caused by quinolones does not respond to conventional treatments and leads to
very disabling conditions, usually attributed to other causative factors (leg
length discrepancy, worn shoes, lack of flexibility, muscle imbalance,
over-pronation, supination, misalignements, wear, tear, etc...).
As a result, many of these problems
are improperly diagnosed and remain elusive to all the treatments of choice
devised for other pathologies. When conventional treatments (corticoids,
steroids or anti-inflammatory medications) are used for disorders caused by
quinolone antibiotics, they can cause great additional damage that can lead to
tendon ruptures and permanent disability.
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VERY IMPORTANT: Quinolones can cause extremely serious illnesses,
organs destruction, life threatening disorders, inmunological and incurable reactions,
as well as fatal outcomes. The present FLOX-REPORT does not treat those
really rare events, neither allergic reactions to quinolones. The present FLOX-REPORT only treats the common, true
nature, toxic side effects of quinolones that this class of antibiotics cause
to everybody when taken in therapeutic doses by healthy and normal people. |
That is the reason why there is
an imperative need for clearer and more honest information about this class of antibiotics
called quinolones and fluoroquinolones. The present report is a summary of many
real cases studied over the last several years that shows a closer picture of
the real toxic nature of quinolone antibiotics.
The current version of the
present report focuses mainly in SEVERE reactions experienced by previously
healthy and young athletes. And, therefore, it is more focused on all areas
relevant to physical and athletic performance. After studying dozens of cases
in detail, the similarity between all of them is very striking. A few other
hundred cases have been analysed in less detail to form the report.
As the report is large, some
sections are repetitive, in order to facilitate and inform and they can be
consulted quite separately. In the report we do not make any distinction
between quinolone and fluoroquinolone antibiotics because both subfamilies
share the same toxicity.
3.WHO WILL BENEFIT FROM THIS REPORT
You may find this report helpful
if:
You
are looking for a connection between your recent physical problems and the
drugs you have been taking lately or have taken in the past.
You
are concerned about a prolonged course of fluoroquinolones (i.e. Cipro,
Levaquin, Floxin, etc.) that you have been prescribed and are about to start.
You may have taken quinolones in the past, and are planning
to take a more prolonged course of these antibiotics, so you want to obtain
more information and have a clearer picture.
You
are a medical practitioner and want to learn more about the patient’s point of
view regarding this dramatic health problem.
|
HOW TO USE THIS ARTICLE IF YOU ARE A PERSON THAT HAS SUFFERED A
REACTION TO A QUINOLONE This article might be useful to help you to understand where you are
during the first stages when you are wondering what is happening to you, why,
and who to ask for help. The article could help to overcome your
disorientation. The article could save you erratic searches for answers and
could contribute to facilitating a general overview of this health problem.
The article does not contain much information that you cannot collect
anywhere else after months of research. This article must not be interpreted literally. It is not a manual for
those intoxicated by quinolones. You should not attempt to fit your case in
any of the groups or scales provided herein, because they are average
experiences. Many reactions have 80% or 90% of common symptoms, especially in
severe cases, but in mild and intermediate intoxications there is a varied
range of personal conditions, although always within the common thread of the
well-known specificity of the reactions to quinolone antibiotics. |
As you can learn through the
paper, for the sake of simplicity we have rated the reactions to quinolones as:
MILD, INTERMEDIATE and SEVERE. Severe reactions are relatively unusual and
really different to all the rest. This article deals especially with the
implications of SEVERE reactions to fluoroquinolone antibiotics. Nevertheless,
this report is not a reference for current long-term sufferers of quinolone
toxicity because it does not add new information to the wealth of it already
available. When a floxed person is one year out from the initial intoxication,
he/she will not probably find much information useful in this report because by
then an aware and informed person will possess a more comprehensive knowledge
than the one provided by this paper.
This report may help you to have
a first glimpse about the toxicity of the quinolone antibiotics. From there on,
what counts is what you learn on your own or with the help of your doctors.
We recommend that you read the
report with a critical perspective and also read from other sources, to form
the big picture that a floxed person really needs, until the medical class
decides to take on the subject and acknowledge this disorder.
The awareness about quinolone
toxicity is in its infancy. We see this struggle as a relay race. We feel we
are about to complete our final lap. We hope that new people take over the
baton and soon the present report becomes superseded, rudimentary and
forgotten. This is the real objective of our work, that is to say, to
contribute along with other web sites to unveil and reveal this tragedy and to
prompt proper research. We would be especially happy if a medical research team
conducted an honest, independent, thorough, thoughtful and long- term survey of
the toxicity of quinolones.
4.LIMITATIONS OF THE REPORT
This report is not a compendium
about quinolones. To start with, for the technical molecular structures and
pharma-dynamics, and for all the virtues of the quinolones, you can visit the
websites of the drug manufacturers. We focus on the dark side of the
fluoroquinolones, which is dark because no light has been shed on it until now.
Take a look at a professional pharmaceutical drug monograph (drug insert from
the manufacturer) about a typical quinolone to get a first notion about their
use, dosage, and directions for use, along with a list of adverse effects and
their prevalence (the percentages you will read there are crudely manipulated).
A good site for monographs of drugs is www.rxlist.com.
This report has failed to meet
some of its initial objectives, because it has not discovered any relevant
details. Some very minor correlations have been postulated for the first time
by some floxed persons that have collaborated with the report, like the
vascular-matrix implication, and a handful of casual links between intensity of
symptoms and foods (soy, omega-3 and sugar for example). Or some potentially
interesting therapies like the enriched plasma treatment, which could also
eventually prove itself useless for our tendons. None of them have made a
difference and all of them could be proven wrong in the near future.
Sometimes, new updates are
included in a given section and therefore do not reach the whole report
resulting in the appearing of some small contradictions between sections. We
thank you in advance for any comments with this aspect, that you can send
through the contact link if it is operative.
If you are reading the English
version of the flox-report, take into account that it is a translation of its
original language and that many technical words have been translated from their
Latin root, which in central
Although we have talked to
hundreds of people suffering from this syndrome and we have tried to use
logical methodologies to draw many conclusions, from observation, repetition
and comparison alone, we cannot aim to discover the mechanism of damage, or the
elusive clues for a healing protocol.
5.COMMON MISTAKES DONE READING THIS PAPER
For a person that is starting to
become aware of his/her intoxication by a quinolone antibiotic, the contents of
this report can be overwhelming, depressing and frustrating. So much
information mixed in a lay document has two big disadvantages: Firstly it can
confuse some because there is some difficulty to discern between real medical
research and personal opinions, all of them from floxed persons. In second
place, some people may think that this is a compendium of information and feel
they do not have the need to look for information elsewhere. You have to avoid
both disadvantages of the report and read it with a critical, detached attitude
and look after your own information and expanding awareness.
You should NOT read this report
if you are the kind of person that believes he/she has all the symptoms of any
illness that you read about (hypochondria). If you do, you will end up
convinced that you are suffering a far worse reaction than it really is, and
that will make you suffer unnecessarily.
The experience of previous
editions of this paper shows that some floxed persons want at all costs to
match and rate their reactions against the tables and graphics of this paper,
in order to have an instrument to rate their reaction, have a precise time
schedule of recovery, make normal plans and foresee in advance every event that
is going to happen during their recovery, no matter how minute may it be. This
paper cannot do that and it is not its objective. After reading the report you
will only get an idea of what a floxing is (the suffering of the toxicity of a
quinolone antibiotic), but no information to evaluate your reaction is provided
here. The tables and graphs have been obtained from different samples of
people, have not been scientifically controlled and their only aim is to
provide a contrast experience -based on imperfect but real life facts- to all
the mainstream official information that denies the possibility of what is
really happening to thousands of people all over the world.
If you attempt to use this paper
as a guide for your illness, you will become frustrated and you will devoid
yourself of the necessary perspective and strength to handle your intoxication
adequately. This paper is not the helping hand that can lead you to a certain
sense of normalcy.
As a fellow floxed person, known
for his tireless and exhaustive research once said (reproduced with
permission):
"After
researching these issues for years now and talking to tens of thousands of
individuals I have found that the bottom line is that there is no bottom
line. Everybody is different,
everybody's experiences are different and what works for one is a disaster in
the making for another. Nobody is right
when everybody is wrong. Some people
have died, some have been crippled for life, some have recovered to a degree
and others have recovered completely. No
rhyme, reason or logic is to be found within all the data. Your chances of recovery are pretty much the
same as the next guy, zero to one hundred percent, or somewhere in between.
We really do not
understand the mechanics behind these reactions. We have theories, and just like opinions,
everybody has one. We have few studies that actually explain what is going on. Mostly dealing with the tendon damage, which,
by the way, has been extensively documented as to causation.
Recently we have
added hypo and hyperglycemia as well as heart damage as subjects that are under
investigation. But for the most part
nobody has done any kind of in depth study of our problems. There are just too many of them, which defy
logic as well as the investigative tools available to the average
physician. We are a Rubic's Cube without
a solution. No matter how many different
ways we turn the cubes the solution escapes us.
We may never know what
is wrong with us during our lifetime.
But what we do know is that we are far from alone and time seems to be
the only reliable treatment available.
Not to be measured in days, weeks or even months but years. Perhaps someday someone will take pity on us
and provide us with an answer. But the
hard cold fact is that we haven't a clue and that day has yet to arrive. This is what I have learned over the past six
years. Myth or fact? Who the hell knows?" .
Suffering a floxing is a life
altering experience, that does not resemble any normal illness process that you
have experienced before in your life--like post-surgery, an infection, or
post-traumatic recovery. Most likely, all health issues that you had prior to
the floxing started to heal as soon as the offending agent was removed. Not
with quinolones. You will feel progressively worse for months or years before
some levelling off is felt. With your prior illnesses, there was something to
be done: take medications, put a cast on, and perform rehabilitation exercises;
Apparently nothing can be done to halt or reverse or help healing from a
quinolone intoxication a few days after ending the treatment. Is very much like
suffering from chronic degenerative illnesses like the toxic oil syndrome, the
gulf war syndrome, lyme, lupus, multiple sclerosis and others.
If you have one or a few symptoms
of a severe reaction--that does NOT mean that you have a severe reaction. It is
the whole entire picture that counts. We have seen too many floxed persons
enduring really mild reactions becoming hypochondriacs with the possibility of
having a severe reaction and magnifying real or imaginary symptoms to match
those of a severe reaction.
Another extremely common mistake
is to let oneself become overcome by an overzealous search for exact answers,
explanations, cures, treatments, timetables and protocols for any minor symptom
that shows up-- like extremely negligible physical changes or events that take
place in one's life and that would be ridiculously ignorable even in a healthy
person.
Overreaction to the quinolone
intoxication causes many floxed persons to become worried and look for
quinolones laying in wait at every corner of their lives, or extremely afraid
and obsessive about potential negative influences of normal habits, like taking
a shower with tap water tainted with fluoride.
To look at life through the cipro
or levaquin lens only adds anxiety and despair to the already intense impact of
the intoxication.
Take into account that if one
victim that has participated in the flox-report recovered from a symptom in 7
months and another in 17 months, the AVERAGE indication is about 12 months for
recovering from that symptom. If after reading this flox-report you try to
establish at all costs the predicted recovery date for that symptom of yours,
and you are a person that let us say is going to heal from that symptom by
month 18, you will surely get very anxious and depressed when you do not feel
well by month 12. Above all, keep in
mind that your reaction is unique, and that nobody and no report or paper can
substitute for your knowledge about your symptoms, your recovery and all your
health aspects.
6.TERMS THAT MAY CAUSE CONFUSION
For the sake of simplicity, we do
not discern between the terms side effect, adverse reaction, adverse effect,
although some doctors do. In our case we also frequently use the word
"intoxication" to describe what a floxing is; that is--nothing but
the predictable result of the guaranteed toxicity of the fluoroquinolone antibiotics.
We also extensively use the term
"delayed" for reactions that become apparent months or years after
exposure to fluoroquinolones. Most doctors only consider "delayed" a
reaction to a drug that takes place 2 to 7 days after exposure and that
normally shows up as a dermatologic (skin) abnormality. Accordingly, most
doctors -out of sheer ignorance- think it impossible for a new symptom to
happen at 6 months post-exposure, for instance.
We use "allergic" for a
sudden, extremely acute and intense reaction that can be life threatening, with
or without anaphylactic reaction, and that can take place with any substance
that enters a body. The flox-report does not treat those cases because they are
irrelevant to our purpose.
We use the term
"inhibit" accordingly with its technical and precise definition in
biology; to inhibit means to decrease, limit, or block the action or function
of (an enzyme or organ, for example). It does not necessarily mean that the
action or function is entirely suppressed.
We have rated the reactions as
mild, intermediate and severe. The ratings are average experiences. The rating
itself is a fiction, because each reaction is unique and cannot be classified.
But it simplifies the handling of information and the explanations. For
undifferentiated reactions of a certain intensity we use the terms strong,
intense, high or something similar.
Much effort has been focused on
trying to introduce a lay floxed person to the basic concepts of medicine
necessary to understand some principles of the floxing syndrome. Using simple
terms and explanations is easier than true medical terminology, so some terms
and explanations have been simplified so much that are not medically correct.
The paper is over 260 pages long
and takes some time to read, especially if you go back over certain passages
that request several readings before understanding them. So it is recommended
to focus on the sections of the paper that you prefer.
7.WHY HAS THIS REPORT BEEN WRITTEN
There is little or no medical information
publicly available via the Internet for the general population that deals with
the practical side of adverse reactions to quinolone antibiotics.
The only real information
available to date comes from the support groups sustained by sufferers. We
strongly recommend visiting the webpages:
Those sites belong to their
owners and do not have any relationship with the authors of this report. In
particular, www.fqresearch.org
is a very comprehensive database on fluoroquinolone and quinolone antibiotics and
is a mandatory visit that will save you hundreds of hours of research if you
decide to take the responsibility of doing your own research.
Nearly all the medical
investigations in progress are not comprehensive. The researchers in charge
have a sheer lack of knowledge about the real and true facts of this syndrome.
Many investigations are very superficial, nearly anecdotal, and only look after
a publishable paper, so that statistics of activity in the scientific group
remain high in the annual report. There are myriad scope-limiting articles, all
of which have contributed to extensive data, plus many, many instances of
scientific evidence supporting the great damage that quinolones inflict upon
people, but there is not a single comprehensive study about the adverse effects
caused by quinolones.
No consistent clinical studies
can be found that put the real figures of adverse effects where they really
are. There is not a single study that shows the true extent of the damage caused
by these antibiotics. There are multiple causes for this lack of proper
investigation:
The
pressure exerted by drug manufacturers, the propaganda they spread in medical
circles, and the counter-studies that they promote, most of which are unscientific
creations of well paid doctors that show “evidence
according to their personal experience" of maximum beneficial activity
of the antibiotic and their “negligible”
adverse effect profile. We can even see irresponsible and poorly educated
doctors prescribing and recommending quinolones for children, when currently
there is overwhelming evidence that quinolones cause cartilage and joint
injuries of extreme severity in immature persons.
The
manipulation of the post marketing adverse events performed by the "industry" (laboratories),
that make all that is in their hands and to label the most appalling severe
reactions to quinolones with the assertion that "unequivocal link of the event with the quinolone ingestion could
not be proved" and thus dismissing most of the reports of serious
reactions, and keeping the statistics of toxicity intentionally low.
Manufacturers only consider the possibility of toxicity before a quinolone
reaction when a doctor states boldly that there was not any other concomitant
agent causing the adverse event, or when the patient has been re-exposed to the
quinolone and the reaction cannot be blamed on anything else.
The
delayed onset of symptoms is perhaps the most important fact that is
universally ignored by doctors. Many researchers only monitor patients while
they are on the medication and in some isolated cases "up to a month later”. The vast majority of disorders appear
months or up to a year and a half later and are therefore never linked with the
real cause. In most issues related with nerve toxicity, a floxing is a
delayed-onset-neuropathy.
The
lack of knowledge and preparation of the doctors that prescribe them and the
aspect that doctors nearly always dismiss their patient’s complaints, and their
refusal to admit any link between the severe and long lasting pathologies and
their causal agent: the quinolones. The ignorance of doctors about the toxicity
of quinolones is simply appalling, irrational and unjustifiable. Many doctors
are handing out lifelong misery to their patients and destroying their lives
forever.
This report will help the
non-medical population know more about the true and real-life nature of
quinolones. It can also be a wake-up call for the caring doctor to learn a
different point of view, promote a more critical approach and perform unbiased
professional research prior to prescribing quinolones.
There is a need to convince the
medical class that:
Until
better antibiotics are developed, a defectively designed drug like a quinolone
antibiotic should be restricted to emergency, complicated infections or life or
death cases, but never used as a first line of treatment. Quinolones are not an
antibiotic in the traditional sense, but a toxic chemotherapeutic agent, with
very severe and long-lasting adverse effects.
Thousands
of affected people need help, and adequate research is urgently needed in order
to determine the mechanisms by which these drugs cause their damage, and how to
limit their effects.
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PLEASE REMEMBER: Half of the quinolone antibiotics marketed in the
last twenty years have been withdrawn from the market because of their great
toxicity. Two of them during the life of this paper. |
It is a shame that patients and
victims once again have to write reports like this, placing themselves years
ahead of their doctors. In ten years time the essential information contained
in this report will already be common knowledge for thousands of persons, and
it will be "discovered" by
the medical class and then become accepted knowledge. Too late for too many. Is
this the medical class that we deserve?
8.HOW HAS THIS REPORT BEEN WRITTEN
Nobody that has collaborated to
create this article has had any previous reaction to any drug, food or
allergen. We all were healthy people. We come from different backgrounds,
races, social classes, and we don’t share any common physical aspect that makes
us more prone to be injured by quinolone antibiotics. It only happens that we
have managed to link our health problems to the exact agent that caused them.
In nearly all cases, we noticed that the drug was damaging us during the
treatment, but by then most of us had already taken the entire quantity of the
prescription. Others reported to their doctors that the quinolone was causing
pains but the doctors dismissed any link between the symptoms and the drug and
asked them to continue on with the treatment; even though the patients
themselves knew their bodies well as trained athletes and there was no doubt
about what was happening. Some people started to feel bad after ending the
treatment.
The statistics of this report
have no objective value. They are a gross attempt to illustrate some facts that
are better seen through some numeric figures. The sources of information for
elaborating the statistics of this report come from individuals that have
collaborated, sometimes in an organized manner and other times rather
spontaneously. The amount of data behind some conclusions is scarce some times,
but that has not deterred us from attempting to make some deductions, all of
them objective. For a few issues, the amount of data handled has been simply
huge. Do not forget that one of the most important practices of clinical
research is reporting individual cases ("case reports"), because they
help to outline the medical issues at stake. We have not used the case-report
technique much (because intoxications to fluoroquinolones can be very unique),
and have attempted to study at least small groups of people for every aspect of
our research.
One source of data used to write
some passages of this paper comes from the experience of a group of people with
the following profile:
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-TABLE 1- STATISTICAL PROFILE OF A WELL STUDIED GROUP
OF PEOPLE RELATED TO THIS REPORT |
|
|
|
|
|
Number of persons |
42 |
|
People with complete recording of data and
battery of tests |
18 |
|
People with partial recording of data and
battery of tests |
24 |
|
Sex |
78% male, 22% female |
|
Age |
28 to 56; mean 39 years at the
onset |
|
People without any prior major medical
problem: |
37 |
|
People without any prior known allergy to
medications: |
36 |
|
People without any prior known immunological
or rheumatic disorder: |
37 |
|
People that suffered a mild reaction to
quinolones |
6 |
|
People that suffered a mild to intermediate
reaction to quinolones |
11 |
|
| |