PART
III:
TOXICITY
OF
FLUOROQUINOLONE
ANTIBIOTICS
13.TOXICITY OF FLUOROQUINOLONE ANTIBIOTICS
Quinolones are very toxic
antibiotics. They are not biological products but purely man-made chemical toxic
compounds for killing bacteria, and ultimately, your body and its many
structures and systems. High doses or prolonged courses cause a
disproportionate percentage of adverse effects. Although most laboratories and
manufacturers rate the number of adverse reactions as being very low, the real
figures are much higher. These drugs are distinctive for one thing: for the
vast majority of people, damage remains unnoticed for many weeks or months,
which does not prompt the patient to stop the treatment, and then severe
disorders develop with many clinical symptoms.
The mainstream medical class
ignores this fact and is reluctant to learn that an antibiotic can inflict such
severe, disabling and long-lasting damage. Consequently, nearly all victims of
this drug toxicity are wrongly diagnosed as suffering from overuse injuries,
neurological illnesses, immune reactions, osteoarthritis, cardiopathies, vision
problems, etc.
Many quinolones are routinely
withdrawn from the market. Recent examples are tequin (extremely serious
hypoglycemia and hyperglycemia) or trovafloxacin, which has been forbidden in
Europe after "discovering"
that it caused many liver failures requiring fulminant transplants and deaths
due to liver failure, along with other extremely severe damage, never
associated before with the ‘innocuous’ trovafloxacin. For health agencies to "discover" these kind of toxic
profiles means that they are so overwhelmed by the evidence of many tragedies
gathered through the years that they can no longer please the requests of
manufacturers to keep the drug on the market and increase the range of use,
ultimately having to ban the drug.
|
TO THINK ABOUT: Quinolones are very toxic antibiotics. As it has happened
with many other drugs before, the medical class still ignores it all. |
Normally, manufacturers are very
keen at manipulating the results of the final phases of drug trials, and
concealing the risks to patients. The industry
is also very proficient at pursuing and discrediting any independent report on
adverse effects of their medications. As the manufacturers are the almost sole
providers of information to the health agencies, the health agencies normally
only act after years of having proof that people were dying and being severely
injured due to toxic drugs. You can learn more about the subject through many
investigative and authoritative reports that have been published over the past
several years. More on this issue is briefly discussed later in this paper.
Many quinolones are in the
process of entering the market, both as generic forms and as new brands (all
the manufacturers want to have a "me-too"
compound that sells at high prices, so always find out to which class of antibiotics
the drug you have been prescribed belongs.
For the purpose of this report we
will call FLOXING SYNDROME the set of disorders caused by quinolone
antibiotics. In medical terms it would be called QUINOLONE TOXICITY SYNDROME
(QTS).
There is very little -if any-
clinical knowledge about this syndrome, as it is not yet recognized as a major
health problem, and no protocol for healing has been developed so far. There is
not a single scientific study performed in order to better understand the true
nature of the toxicity or to make a treatment available. Unfortunately, there
are no specific tests or markers that can objectively diagnose the syndrome or
the extent of its severity at any given moment. The vast array of symptoms that
usually accompany a severe QTS (QUINOLONE TOXICITY SYNDROME) makes the task of
establishing a reliable diagnostic procedure difficult and complicates the
search for a cure.
This syndrome is so widespread,
yet unrecognised, that it could constitute in and of itself, a specific kind of
neuromuscular, systemic disorder that affects all body systems, and as a result
deserves to be studied and treated separately as a branch of the drug-induced
generalized disorders.
14.WHAT CAN I EXPECT FROM TAKING A QUINOLONE ANTIBIOTIC
NOTE:
Everybody can have
an allergic or hypersensitive reaction to any drug. Also, some people are good
metabolizers (their livers for instance can process the drugs easily) but
others are poor metabolizers (their livers cannot break down drugs properly so
they build up in the body up to toxic concentrations).
All the statistical
and research data provided in this paper is based on experiences of people who
are non- allergic, not hypersensitive and considered as normal metabolizers of
quinolones (quinolones have to be broken down by liver enzymes).
Like many other drugs, quinolones
are highly toxic medications. A special feature and the worst problem posed by
quinolones is the severity and irreversibility of many of the injuries that
they cause, some of which emerge long after finishing the treatment, when there
is no possibility of stopping the ingestion of the drug.
In general, you should ask your
doctor to prescribe another -less toxic- antibiotic, if there is an alternative,
because all doctors with proper knowledge on quinolones (including FDA
officials) share the opinion that quinolones should be a carefully
administered, second or third line of defense, antibiotics.
In any case, the toxicity does
not show up with significant symptoms if you take short courses and low doses.
Used in low doses (250 to 500 mg of the equivalent to ciprofloxacin potency
daily) for short courses (up to one week) these antimicrobials have a low toxic
profile.
The whole problem with the
quinolones comes from their very narrow safety profile, which is rarely
respected.
Although it is difficult to
objectively establish the limits of what could be called "safe" or
"unsafe", it is very clear that the clinical practice for prescribing
quinolones is generally far beyond the safe margins. The inadequate and risky
practices are:
prescribing
doses much larger than necessary
prescribing
courses much longer than necessary
not
adjusting doses for weight and build
not
testing the liver and renal functions prior and during long treatments
not
taking into account prior ingestion of quinolones and the cumulative effect
not
looking for adverse effects up to several months after completing the treatment
dismissing
or not identifying the first symptoms of the intoxications
prescribing
the quinolones to people under age of 18
not
checking the interactions with other drugs and foods (caffeine, theophylline,
grapefruit and many others)
FLUOROQUINOLONE
UTILIZATION IN THE EMERGENCY DEPARTMENTS OF
ACADEMIC MEDICAL CENTERS. Prevalence of, and Risk Factors for,
Inappropriate Use. Arch Intern Med.2003
We
studied 100 consecutive ED patients who received an FQ and were subsequently
discharged. Appropriateness of the indication for use was judged according to existing
institutional guidelines. A case- control study was conducted to identify the
prevalence of, and risk factors for, inappropriate FQ use.
Results:
Of 100 total patients, 81 received an FQ for an inappropriate indication. Of
these cases, 43 (53%) were judged inappropriate because another agent was
considered first line, 27 (33%) because there was no evidence of infection
based on the documented evaluation, and 11 (14%) because of inability to assess
the need for antimicrobial therapy. Although the prevalence of inappropriate
use was similar across various clinical scenarios, there was a borderline
significant association between the hospital in which the ED was located and
inappropriate FQ use. Of the 19 patients who received an FQ for an appropriate indication,
only 1 received both the correct dose and duration of therapy.
Conclusions:
Inappropriate FQ use in EDs is extremely common.
The result is a very high
incidence of adverse reactions, some of which impair people for life.
15.THE EPIDEMIC OF TOXICITIES OF QUINOLONES
15.1. The epidemic of sick people directly treated
with quinolones
Those safety principles stated
above should only be overruled in critical cases, after properly assessing the
risk-benefit ratio. However, less than 15% of all the quinolone prescriptions
meet the safety criteria, hence the epidemic of intoxications that plagues
people in all countries. In other words, being antibiotics with an
extraordinary toxic potential, they are prescribed carelessly, randomly, and
indiscriminately.
This epidemic is one of the least
recognized for now and one of the easiest to avoid. The only thing at stake is
the revenue of the manufacturers of these antibiotics, which not surprisingly
are among the most expensive on the market. But that does not mean that they
are expensive to produce and it is known that the initial development costs
were recovered years ago.
This epidemic affects both people
that are very resistant to quinolones (whose bodies, especially their livers,
metabolize the quinolones properly), but specially people that are
hypersensitive to quinolones, poor metabolizers or intolerant to those
medicines because of other reasons.
15.2. The epidemic of sick people that take quinolones
through food
The "industry" (the manufacturers) produces quinolones
massively for veterinary use. Some developing countries sell quinolones
internationally for fish and cattle, literally by the ton. Much of the poultry
on the market in Asia, America and Europe has been raised and fed with
antibiotics (quinolones included) from the first day of their lives to the
last, and then directly to our dinner plates. In 2005, quinolones have been
forbidden in the
Oddly enough, the medical associations
and citizen groups are concerned only with the effectiviness of the antibiotics
in the long run and not with the adverse health effects of antibiotics in our
foods. They correctly advocate that new bacteria resistant to quinolones are
housed by the birds, that can pass on to people and for which one day there
could be no effective treatment available. For that reason they theorize that
quinolones should be banned for meat and fish production, to which the
manufacturers of quinolones exert a strong opposition, putting their lobbyists
into action at all political levels.
Although these worries are
justified and seem appropriate, equally important is the fact that the content
of quinolones in some food is far beyond reasonable amounts and cause sickness
in people sensitive to them and in normal people by accumulation, not to
mention to people that are recovering from a quinolone intoxication. Thus,
there is another silent, low grade epidemic, the one caused by the intoxication
caused via ingestion of quinolones in food, which manifests as fibromyalgia,
neurological problems of every kind, insomnia, psychological disorders,
osteoarthritis, and others.
16.WHAT ELSE SHOULD BE INCLUDED IN THE PACKAGE INSERT?
The pharmaceutical package
inserts for prescription quinolone antibiotics contain gross underestimations
of severe adverse effects. These adverse events are presented as rare or very
rare, when in fact they are very common or even unavoidable, that is to say,
predictable, as it has been shown by some epidemiological studies.
In order to help you to get an
idea of the real toxicity profile of quinolone antibiotics, take into account
that had it not been for the manufacturer’s manipulation and FDA consent, the
package insert would read:
This
drug is neurotoxic. The effects of this drug are cumulative, so ask your doctor
to keep a record of the total amount ingested by you, so that currently
supposed safe levels are not surpassed. The neuropathies associated with this
drug (with sensory as well as motor and autonomic involvement) are often
severe, lasting for many years or permanent.
The
therapeutic effects of this drug disappear with drug cessation, but the adverse
reactions can manifest weeks, months or for up to two years later, so report to
your doctor any abnormal bouts of neuropathies, central nervous system disorder
like insomnia, nervousness, tendinitis, joint pains, muscle pains, twitching,
fasciculations and/or body trembling, visual disturbances such as decreased
visual acuity, dry eyes, blurred vision, double vision or other dry mucous
symptoms (mouth, nose, skin, ears, etc¼) as well as all the rest of
symptoms listed in the package. In many cases the resolution of symptoms takes
several years.
This
drug will deteriorate the cartilage all over the body as it kills the
chondrocytes, the root cells of cartilage. The damage depends on the previous
state of you cartilage, plus the dose and length of quinolone treatment. Do not
take this drug if you suffer from early osteoarthritis, if you frequently play
sports or perform strenuous tasks or exercises. Usually, the damage inflicted
is irreversible.
|
TAKE NOTICE: Quinolones cause permanent injuries, especially degeneration of cartilages
in knees, hips, spine, and shoulders, plus irreversible damage in the eye,
fatal arrythmias and irreversible neurological disorders. |
During
the post marketing surveillance of this medicine, unexpected tendinitis and
ruptures of major and minor tendons have been reported in all kinds of people.
Ruptures reach 50% and more in persons that take this antibiotic with
corticosteroids. In young, healthy and active people tendinitis becomes
symptomatic in 5% of persons for low dose and short treatments, and in 100% of
people with the highest doses approved and/or long treatments. The injuries of
the tendons tend to heal very slowly, and in many cases they become chronic or
permanent. The injuries of the tendons are cumulative; so keep a record of the
total amount of quinolones ingested in your life.
This
drug is not recommended for those who have been diagnosed with autoimmune
disorders, or if there is a suspicion
about one being present. It can cause conditions similar to, as well as worsen
or release, autoimmune disorders like multiple sclerosis, lupus erithematosus,
rheumatoid arthritis, small vessel vasculitis, dermatomyositis, polymyositis
and others.
Quinolones
can cause fatal arrythmias and other heart injuries. Do not take them if you
suffer from any heart condition or a history of palpitations or irregular
heartbeats.
Elderly
people, diabetics, patients with impaired renal function, persons under 18
(whose bones and cartilage are still growing) and people taking corticoids are
at great risk of suffering very disabling
reactions.
In
order to avoid skin cancer and eye lesions,you should protect your skin and
eyes against strong sunlight and refrain from sunbathing for at least one year after taking a fluoroquinolone.Consult
your doctor to adjust this period according to the dose you are planning to
take.
All of these statements will be
acknowledged by the medical community in the years to come, only too late for
thousands of people whose lives will have already been meaninglessly ruined.
Keep in mind that half of the
quinolone antibiotics marketed in the last twenty years have been withdrawn
from the market because of their great toxicity. The quinolones currently
available are just slight variations (shifting the position of one atom or
molecule) of the openly toxic quinolones, and are still very toxic. The magic
of the new position of the atom is that the toxicity is more concealed,
cumulative, delayed, internal, and mimics better other serious illnesses.
17.REAL RATES OF ADVERSE REACTIONS
There are enough
published reports and Rx lists about these drugs. You can find them on the
Internet. The list of adverse effects for each quinolone drug is extensive, and
many of the adverse reactions will manifest in normal people with long treatments
or high doses, or just with one pill in extreme cases of intolerance.
Remember that the
"rare" frequency of adverse reactions stated in the pharmaceutical
package inserts is usually grossly underrated. The statistics provided by the
manufacturers are a gross manipulation of biased clinical trials, and are
totally unreliable. For a better assessment of your chances of getting
seriously ill, consider the table 3 instead. We do not understand either why
the package inserts do not discern among probabilities of having adverse
reactions for different lengths of treatments or why they do not adjust the
doses for body weight, age, or liver and renal impairments.
Let us suppose that
you are a healthy, young person, you are not taking any other medications and that
you are the perfect patient- not allergic to anything and able to metabolise
most commonly marketed drugs without experiencing adverse effects; then your
chances of developing clinical symptoms of serious disorders caused by a
quinolone antibiotic are:
|
TABLE 3. ADVERSE EFFECTS OCCURRENCE FOR QUINOLONE
ANTIBIOTICS (Using ciprofloxacin potency as
reference). (People of up to |
||||
|
THERAPEUTIC REGIME / DOSAGE |
PERCENTAGE OF ADVERSE EFFECTS |
DURATION OF THE ADVERSE EFFECTS |
||
|
SEVERE |
INTERMEDIATE |
MILD |
||
|
up to one week of up to 1,000 mg daily |
7% |
18% |
25% |
Several weeks to months |
|
6 weeks of 1.000 mg daily |
58% |
86% |
100% |
Months to years |
|
more than 6 weeks on a 1,000 mg/day basis |
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 |
92% |
100% |
100% |
Many years or permanent |
|
For the interpretation of what is a SEVERE,
INTERMEDIATE or MILD reaction, consult further in the report. |
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This table has been
prepared with the input of more than 40 individuals, the majority of them, but
not all, belonging to the cohort of table 1. It is updated periodically with
the data rendered by the passing of time and new incorporation of people.
For people that weight
much more than
Please, read table
3 correctly. If you weigh around
|
TABLE 4 RELATIVE POTENCY OF QUINOLONES USED IN THIS REPORT |
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|
DRUG |
MAXIMUM DAILY DOSE |
RELATIVE POTENCY ADOPTED |
|
Ciprofloxacin (Cipro) |
1500 mg/day |
1,00 |
|
Enoxacin (Penetrex) |
800 mg/day |
1,50 |
|
|
400 mg/day |
exceptionnally toxic |
|
Levofloxacin (Levaquin) |
500 mg/day |
2,00 |
|
Lomefloxacin (Maxaquin) |
400 mg/day |
-- |
|
Moxifloxacin (Avelox) |
400 mg/day |
2,00 |
|
Norfloxacin (Noroxin) |
800 mg/day |
-- |
|
Ofloxacin (Floxin) |
800 mg/day |
1,50 |
|
|
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