- 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- all of which had been withdrawn from the market in recent years (3).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grepafloxacin are two other fluoroquinolones now withdrawn from the market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 practioner
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 pfpc@istar.ca
-
- 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&live
r
-
- 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&rena
l&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=photorecep
tor&fluoride
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