October 21, 2001
Dear All,
Two months ago we reported on the withdrawal of Bayer’s
BAYCOL (Cerivastatin), a fluorinated drug (statin class) which had caused
deaths and serious adverse health effects worldwide (1,2,3).
BAYCOL had been found to cause muscle destruction/wasting
- a condition known as rhabdomyolysis - and displayed compounded toxicity when
used with other drugs. It had been
linked to at least 31 deaths.
We also showed how the adverse reactions documented with
BAYCOL were largely identical to those of numerous other fluorinated drugs -
all of which had been withdrawn from the market in recent years (3).
ANTHRAX AND CIPRO
As a result of the current Anthrax scare another
fluorinated drug called CIPRO has received extensive media coverage and the
name has become familiar to millions almost overnight. As soon as the first
cases of anthrax resulting from suspicious mail became known, there were wide reports
of a hectic run on this drug.
Mass hysteria seems present as governments, pharmacies and
individuals everywhere are stockpiling this drug. Pharmacies are reporting
record sales, and on-line prescription services and Internet sites are found selling
the drug at more than $7.00 per pill.
People everywhere, hyped into believing their flu-like
symptoms are caused by anthrax exposure and mis-informed by irresponsible media
reports, are taking CIPRO, and worse yet
- are giving it to their children.
WHAT IS CIPRO?
CIPRO is ciprofloxacin, a fluorinated quinolone, belonging
to a class of fluorinated antibiotics which also include enoxacin, fleroxacin, temafloxacin,
grepafloxacin, norfloxacin, sparfloxacin, tosufloxacin, lomefloxacin,
ofloxacin, etc..
Ciprofloxacin has been in use since 1987 for a variety of
other indications and is the most-widely used fluoroquinolone in humans and animals
worldwide (4).
In 2000 the FDA approved its use in treatment for
inhalational anthrax under its “accelerated approval” regulations (5). It had
actually taken the unusual step of urging Bayer - the sole manufacturer for all
countries except India - to file for such approval, supposedly in order to
protect the public from future terrorist attacks. The US Department of Defense
had already ordered reserves of CIPRO during the 1991 Gulf War (6).
ADVERSE EFFECTS:
As mentioned in the info on BAYCOL, temafloxacin and grepafloxacin
are two other fluoroquinolones now withdrawn from the market because they had caused
severe liver and renal damage - and deaths, just like fluorinated drugs from
other, different classifications (3).
The same information also exists for CIPRO.
Fatal liver failure associated with ciprofloxacin was
reported in the Lancet in 1994 (7, 8 -> 150 more related refs).
Ciprofloxacin has been implicated in several cases of
acute renal failure and is the most established fluoroquinolone to cause such
renal dysfunction (4, 9, 10, 11 -> 96 related refs).
FLUORIDE
The most common side-effects reported due to CIPRO (2-16%)
are gastrointestinal in nature and equal those reported when children accidentally
ingest “too much” fluoride from their toothpaste - such as nausea, diarrhea,
vomiting, and abdominal pain. Why?
Ciprofloxacin administration results in elevated serum
fluoride levels (12). In a series of tests evaluating the safety of ciprofloxacin
in children, serum fluoride levels increased after 12 hours in 79% of the children;
on day 7 the 24-hour urinary fluoride excretion was higher in 88.9% of children
observed (12).
Just as in the case of Baycol and other fluorinated drugs,
CIPRO can cause musculo-skeletal
disorders such as rhabdomyolysis.
RHABDOMYOLYSIS
Since the introduction of fluoroquinolones on the market
in 1987 more than 200 cases of rhabdomyolysis, tendinitis, tendon rupture etc.
have been reported in the literature (4,13,14,15).
In October 1994 the Japan Pharmaceutical Affairs Bureau
was first to amend the product information for fluoroquinolones to state that rhabdomyolysis
may occur (16).
In 1996 the FDA also issued directives to manufacturers to
include warning statements on all fluoroquinoline product inserts to alert
patients and caregivers to the potential for tendinitis and tendon rupture
(17). Also in 1996 the Sri Lanka Drug
Evaluation Sub-Committee decided that the product information of
fluoroquinolone antibiotics should include a warning stating: “The onset of tendon pain calls for
immediate withdrawal of fluoroquinolone antibiotics.” (18)
Achilles tendon rupture was shown to occur even after
withdrawal of the drug. Pathologically there was ultrastructure alteration in
tendinocytes. Just as in other cases of
fluoride poisoning, studies in animals show that magnesium deficiency aggravate
the induced tendinopathy (14,19).
DRUG INTERACTIONS/DEATH:
Just as with BAYCOL, drug interactions with ciprofloxacin
have resulted in fatal outcomes due to potentiation of another drug’s effects
such theophylline (4,20), methadone (21), or warfarin (22).
Just like BAYCOL and other fluorinated drugs,
ciprofloxacin is a potent inhibitor of the thyroid hormone-regulated P 450
enzyme system in the liver. Of all fluoroquinolones, ciprofloxacin and enoxacin
have shown the greatest inhibitory capacity (4).
P450 IA2 prevents
the metabolism/inactivation of methylxanthines, thereby causing increased serum
concentrations of drugs like theophylline and caffeine, which in turn causes
excess CNS and cardiac stimulation. As mentioned above, CIPRO also elevates
serum fluoride levels.
The liver has been identified as a target organ of
fluoroquinolone toxicity in animal studies (23). Already in the 1930s the same
was shown by Bayer’s scientists such as Litzka or Knoll’s Kraft who found that
ALL organic fluoride compounds tested (including those used for fluoroquinolone
production) interfered with thyroid
hormone activity in liver and muscle tissue. Meanwhile, they also showed “anti-bacterial”
activity. This led to the development of many fluorinated medications,
including the numerous compounds then used very successfully in the treatment
of hyperthyroidism (24,25). Kraft invented many fluorinated “medications”. When
it was discovered that some of these organic compounds had the same detrimental
effects on teeth and bone as inorganic fluoride - although much less actual F- was involved - he even filed
patents on behalf of Knoll’s using these compounds in dental preparations
(26,27).
Pregnant women should never take ciprofloxacin. CIPRO
transfers through the placenta. It inhibits P450 1A2 which has been shown to be
critical for neonatal survival by influencing the physiology of respiration in
neonates. Mice lacking this cytochrome
died shortly after birth and showed symptoms of severe respiratory distress
(28). Respiratory distress is a
side-effect of ciprofloxacin also in adults (9). CIPRO also transfers through breastmilk.
RESISTANCE TO BACTERIA
Taking Ciprofloxacin can spur germs to mutate so that
future bacterial infections become untreatable. During the last decades a
dramatic increase in bacterial strains multiresistant to antibiotics,
particlularly CIPRO - has been reported (30, 31, 32). This increase has led to
the occurrence of incurable bacterial infections with a fatal outcome, and a
particularly serious problem in connection with hospital-acquired infections.
For example, Clostridium difficile has become one of the
most common acquired organisms in hospitals and long term care institutions.
The organism typically infects patients whose normal intestinal flora has been disturbed
by the administration of a broad-spectrum antibiotic such as CIPRO. The
diarrhea and inflammatory colitis associated with infection represent a serious
medical and surgical complication leading to increased morbidity and mortality,
and prolonging hospital stays by an average of nearly three weeks. This is
especially true for the elderly and for patients with serious underlying
diseases who are the most likely to develop the infection. C. difficile
associated diarrhea represents a major economic burden to the healthcare
system, conservatively estimated at $3-6 billion per year in excess hospital
costs in the U.S. alone (33).
The emergence of this “antibiotic resistance” is a result
of the overwhelming use of antibiotics in human and veterinary medicine. High rates
of fluoroquinolone resistance have been reported in many countries (30). For
example, in Asia CIPRO no longer can be used to treat gonorrhea, because the
disease has become resistant to the drug (34).
While the FDA in August 2000 approved CIPRO as the
first-line treatment against anthrax, a few months later (October 2000) it
asked Bayer to remove BAYTRIL - its equivalent for animals.
The FDA proposed banning the fluoroquinolones, which
chicken and turkey farmers have given to birds in their water since 1995 to
help shield the animals from infection. The agency acted after linking the
drugs to a jump in Campylobacter bacteria immune to the medications. Nearly 18
percent of one common strain that infects humans are now immune to the very
same drugs which were considered the last line of defense against the
infection.
Campylobacter is the leading bacterial cause of food
poisoning in the United States.
Typically contracted through raw or undercooked meat, the germs afflict
more than 2 million people and kill some 500 each year in the US, according to
the CDC.
While Abbot voluntarily withdrew its version of the
antibiotic (SaraFlox), Bayer decided to challenge the FDA. The company had the option to comply with
the proposed ban or seek a hearing to determine whether such a move was
justified. Bayer refused to comply with
the ban, a move that kicked off a lengthy process that could take years (35).
Meanwhile Bayer gets to poison the world, AND
make huge profits from it...
The AMA has advised its members to prescribe CIPRO very
cautiously, saying the worldwide problem of antibiotic resistance poses future
dangers worse than the anthrax attacks of today (Orlando Sentinel, October 20, 2001).
PHOTOSENSITIVITY
Photosensitization can result when light interacts with
chemical agents in the skin and eyes. This process can produce undesirable
clinical consequences, such as phototoxicity (i.e. exaggerated sunburn),
photoallergy, or photocarcinogenicity. People receiving CIPRO or any other
fluoroquinolone are warned on the product inserts not to expose themselves to
direct sunlight.
Rashs develop on the areas exposed.
Upon UVA-irradiation the “fluorine” of numerous
fluoroquinolones such as lomefloxacin and fleroxacin, are “lost” as fluoride
(36).
“We have discovered that anions can activate visual
photoreceptors in
the dark. One anionic
activator is the commonly used dental agent fluoride.
The data on in
vitro preparations indicate
that these anions modulate photoreceptor biochemistry and
may effect photoreceptors sensitivity...”
[Lewis A - “Fundamental studies in the molecular basis of
laser induced retinal damage” Annual report (Final) March 1 1979 - March 15,
1985 US DTIC records (unclassified) AD#177817 (1985)]
MEDLINE has many articles on fluoride and photoreceptor
activation (G protein-coupled) (35).
OTHER CIPRO SIDE EFFECTS (29):
Abnormal dread or fear, achiness, bleeding in the stomach
and/or intestines, blood clots in the lungs, blurred vision, change in color perception,
chills, confusion, constipation, convulsions, coughing up blood, decreased
vision, depression, difficulty in swallowing, dizziness, double vision,
drowsiness, eye pain, fainting, fever, flushing, gas, gout flare up,
hallucinations, hearing loss, heart attack, hiccups, high blood pressure,
hives, inability to fall or stay asleep, inability to urinate, indigestion,
intestinal inflammation, involuntary eye movement, irregular heartbeat,
irritability, itching, joint or back pain, joint stiffness, kidney failure,
labored breathing, lack of muscle coordination, lack or loss of appetite, large
volumes of urine, light-headedness, loss of sense of identity, loss of sense of
smell, mouth sores, neck pain, nightmares, nosebleed, pounding heartbeat,
ringing in the ears, seizures, sensitivity to light, severe allergic reaction,
skin peeling, redness, sluggishness, speech difficulties, swelling of the face,
neck, lips, eyes, or hands, swelling of the throat, tender, red bumps on skin,
tingling sensation, tremors, unpleasant taste, unusual darkening of the skin,
vaginal inflammation, vague feeling of illness, weakness, yellowed eyes and
skin.
CIPRO causes fluoride poisoning. Will any practitioner
know how to deal with this, considering that the ADA has shielded all from
proper knowledge of fluoride toxicity?
Andreas Schuld, Wendy Small, Trent Harris
Parents of Fluoride Poisoned Children (PFPC)
Vancouver, BC, Canada
1) “Poison Control:
Fluorides, the deadly toxin within” http://www.prn.usm.my/bulletin/nst/2001/nst34.html
2) 7AM - News: “Cures
That Kill?”
http://www.7amnews.com/2001/features/081801.shtml
3) Dr. Mercola - “Baycol
- Another Fluoride Drug Bites the Dust” (PFPC News, August 18, 2001) http://www.mercola.com/2001/aug/18/fluoride_drugs.htm
4) Clinical Toxicology
Review - “What Are Fluoroquinolones?” CTR, Massachusetts Poison Control
System, Vol. 20, No. 3 (1997)
5) FDA TALK PAPER “ APPROVAL OF CIPRO® FOR USE AFTER EXPOSURE
TO INHALATIONAL ANTHRAX” Food and Drug Administration, U.S. Department of
Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD
20857 (2000)
6) CNN - Reuter’s,
July 27, 2000
7) Fuchs S, Simon Z,
Brezis M - “Fatal hepatic failure
associated with ciprofloxacin” Lancet 242:738-739 (1994)
8) 150+ Related
References : CIPRO - Liver
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?form=4&db=m&term=cipro&l
iver
9) Hootkins R, Fenves
AZ, Stephens MK - “Acute renal failure secondary to oral ciprofloxacin therapy:
a presentation of three cases and a review of the literature” Clin Nephrol
32(2):75-8 (1989)
10) Reece RJ, Nicholls
AJ - “Ciprofloxacin-induced acute interstitial nephritis” Nephrol Dial
Transplant 11(2):393 (1996)
11) 90+ Related
References : CIPRO - Renal failure
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?form=4&db=m&term=cipro&r
enal
&failure
12) Pradhan KM, Arora
NK, Jena A, Susheela AK, Bhan MK - “Safety of ciprofloxacin therapy in children:
magnetic resonance images, body fluid levels of fluoride and linear growth”
Acta Paediatr 84(5):555-60 (1995)
13) Australian Adverse
Drug Reactions Bulletin - Vol. 16, No. 2
(May 1997)
14) Ramanujam TR - “Fluoroquinolones - A
Review” (2001) http://www.mcsindia.org/doctors/Epharma/january.asp
15) Petition to Require
a Warning on All Fluoroquinolone Antibiotics (HRG Publication #1399) http://www.citizen.org/publications/release.cfm?ID=6595
16) Information on
Adverse Reactions to Drugs No.128, October 1994
17) FDA Medical Bulletin
- Vol. 26, No.3 (October 1996)
18) 27th
Meeting of the Drug Evaluation Sub-Committee, Ministry of Health, Colombo
(November 1996)
19) Shakibaei M, de
Souza P, van Sickle D, Stahlmann R - “Biochemical
changes in Achilles tendon from juvenile dogs after treatment with ciprofloxacin
or feeding a magnesium-deficient diet” Arch Toxicol 75(6):369-74 (2001)
20) Clinical Toxicology
Review, Vol. 20, No. 3 (1997)
21) Herrlin K, Segerdahl
M, Gustafsson LL, Kalso E - “Methadone, ciprofloxacin, and adverse drug
reactions” Lancet 356(9247):2069-70 (2000)
22) Ellis RJ, Mayo MS,
Bodensteiner DM - “Ciprofloxacin-warfarin coagulopathy: a case series” Am J
Hematol 63(1):28-31 (2000)
23) Guzman A, Garcia C,
Demestre I - “Subchronic toxicity of the new quinolone antibacterial agent irloxacin
in beagle dogs” Arzneimittelforschung 50(5):485-94 (2000)
24) Kraft K - “Über die
Synthese einiger aromatischer Fluorverbindungen” Knoll Research, Chem Ber.
84(2):150-156 (1951)
(describes manufacturing processes of numerous
organic fluorides, after it was shown that all organic fluoride compounds
displayed stronger anti-thyroid activity than the mere “fluoride ion”)
25) Kraft K, Dengel F - “Über
die Synthese einiger aromatischer Fluorverbindungen, II. Mitteilung” Chem Ber
85(6):577-582 (1952)
(more reports on organic fluoride investigations...”in
regards to their characteristics in lowering BMR as well as anti-bacterial
activity”)
26) Zutavern EP, Kraft K
- “Verfahren zur Herstellung von organischen Salzen der Fluorwasserstoffsäure”
German Patent No. 855118, granted Dec. 5, 1950 (Knoll AG)
(Kraft patent
on the same organic fluoride compounds used previously in the treatment of
hyperthyroidism, now patented as anti-caries agents!)
27) Eichler O, Kraft K -
“Verfahren zur Herstellung einer alkalischen, seifenfreien, reagibles Fluor
neben Calciumcarbonat enthaltenden Zahnpasta” German Patent No. 971375, granted
Aug. 28, 1951 (Knoll AG) (patent describing the use of
ethanol-amino-hydrofluorides in toothpaste...)
28) Pineau T,
Fernandez-Salguero P, Lee SS, McPhail T, Ward JM, Gonzalez FJ
·
“Neonatal lethality associated with respiratory
distress in mice lacking cytochrome P450 1A2” Proc Natl Acad Sci U S A
92(11):5134-8 (1995)
29) Cipro Monograph
http://www.healthsquare.com/pdrfg/pd/monos/cipro.htm
30) Coronado VG, Edwards
JR, Culver DH, Gaynes RP - “Ciprofloxacin resistance among nosocomial
Pseudomonas aeruginosa and Staphylococcus aureus in the United States. National
Nosocomial Infections Surveillance (NNIS) System” Infect Control Hosp Epidemiol
16(2):71-5 (1995)
31) Smith KE, Besser JM,
Hedberg CW, Leano FT, Bender JB, Wicklund JH,
Johnson BP,
Moore KA, Osterholm MT - “Quinolone-resistant
Campylobacter jejuni infections in Minnesota, 1992-1998” N Engl J Med 340(20):1525-32(1999)
32) CDC Special Report
: “Emerging Mechanisms of
Fluoroquinolone
Resistance” David C. Hooper
Massachusetts General Hospital, Harvard Medical School,
Boston,
Massachusetts, USA
33) Kurtz CI,
Fitzpatrick R - “Anionic polymers as toxin binders and antibacterial agents” US
Patent 6,290,946, GelTex Pharmaceuticals, Inc. (2000)
34) Orlando Sentinel,
October 20, 2001
35) Bayer Balks at
Banning Poultry Antibiotic - FDA, citing resistance, seeks removal” By Adam Marcus HealthScout Reporter, Dec. 1,
2000
36) Chignell CF - “Mechanisms
of chemically induced photosensitivity” Crisp Data Base National Institutes Of
Health, CRISP/99/ES50046-20 (1998).
37) Photoreceptor/fluoride
- 50+ References
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?form=4&db=m&term=photoreceptor&fluoride
ALL
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