Schuld and Wendy Small
of Fluoride Poisoned Children (PFPC)
Yet another fluoridated drug was withdrawn
from the global market this week.
"Baycol" (made by Bayer AG)
- a cholesterol-lowering drug taken by 700,000 Americans -
was pulled off the market on Wednesday, August 8th. It had
been linked to 31 U.S. deaths.
Bayer would not disclose the total number of deaths worldwide,
but at least nine more fatalities abroad are known.
Baycol had been found to cause muscle
destruction - a condition known as rhabdomyolysis - and displayed
compounded toxicity when used with other drugs.
On August 9th, the European Medicines
Evaluation Agency announced a safety review of other drugs
in the same class as Bayer 's "Baycol".
COMMENT (by Andreas
Schuld and Wendy Small):
This is not the only recent withdrawal
of a fluorinated drug.
The pulling of Baycol follows the earlier
withdrawal of other fluorinated "weight-reducing"
drugs such as Redux, Fen-Phen and Pondimin (September 1997).
Regarding the once very popular drug
combination Fen-Phen, it is important to note that only the
fluorinated compound ("Fen" - fenfluramine) was
withdrawn, while Phentermine ("Phen") was not pulled.
Concerning rhabdomyolysis - other fluorinated
medications have shown the same adverse effect.
Since 1988 - their introduction on the
market - many cases of tendonitis and rhabdomyolysis have
also been reported due to fluoroquinolone antibiotics, which
are used in the treament of a large variety of infections.
In October 1994 the Japan Pharmaceutical
Affairs Bureau amended the product information for Enoxacin,
Fleroxacin, Norfloxacin, Sparfloxacin and Tosufloxacin to
state that rhabdomyolysis may occur. (Reference: Information
on Adverse Reactions to Drugs No.128, October 1994.)
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." (Reference: 27th Meeting of the Drug Evaluation
Sub-Committee, Ministry of Health, Colombo, 26 November 1996.)
"Baycol" (Cerivastatin) is yet
another drug containing a fluorophenyl compound. Prozac and
Paxil are some other well-known drugs containing fluorophenyl
compounds, as are pesticides including Flusilazole and Fluorbenside.
Starting in the 1930s, fluorophenyl compounds
were used as successful agents in the treatment of hyperthyroidism.
Originally used mainly in the dye and pesticide industries,
it had been found by IG Farben (Bayer) and Knoll's scientists
that all fluoride compounds - organic or inorganic - interfere
with thyroid hormone activity.
[It is important to realize that this
disturbance is not caused by the thyroid gland itself. Any
effects on the actual gland are a secondary effect and a result
of the severe disturbance caused elsewhere in peripheral tissue,
particularly the liver and brain.]
Organic fluoride compounds undergo extensive
transformation in the liver, mainly via a process called oxidative
demethylation, involving the thyroid hormone (T3) mediated
P-450 enzyme system.
In many instances the resulting metabolites
may have higher activity and/or greater toxicity than the
Ironically, an example often used as textbook
case to demonstrate of how more-toxic metabolites are produced
after passing through the liver, is a compound called "Sevoflurane",
which is one of many fluorinated agents used in anesthesia.
Inorganic fluoride is a normal metabolite
of Sevoflurane and thought to be responsible for the renal
Fluvoxamine (Luvox) transforms to at least
The activity of organic fluoride compounds
on the P-450 enzyme system is also important as it relates
to the elimination of many other drugs. Inhibition of these
enzymes can cause other drugs to accumulate to dangerous levels
in the body, and many cases implicating fluorinated medications
are documented in hundreds of studies on MEDLINE.
As just one example, fluoxetine (Prozac)
increased up to 13 times the concentrations of thioridazine
and its metabolites in the plasma when both medications were
administered (Daniel et al, 1999).
Drug interaction was also part of the
reason for the Baycol withdrawal.
Liver damage is often observed when fluorinated
agents are used. This, again, is true for all organic fluoride
In 2000, 3M announced a phase-out of "Scotchgard"
discovering that the product's primary ingredient-a fluorinated
compound called perfluorooctanylsulfonate (PFOS) -- was found
in all tested blood bank examinations.
PFOS and related compounds are known to
dysfunction and liver cancer.
Paxil and Prozac are also known to cause
Fluoxetine (Prozac) has been shown to
cause severe liver dysfunction such as hepatitis (Cai et al,
1999; Johnston & Wheeler, 1997; Mars et al, 1991; Friedenberg
& Rothstein, 1996).
Fluoxetine has also shown tumor-promoting
activity in the liver (Lin et al, 1999).
Tolrestat (fluorinated anti-diabetic)
was withdrawn in 1997 after the appearance of severe liver
All fluoride compounds interfere with
Example: Prozac (fluoxetine)
Several studies show that fluoxetine causes
a decline inT3 levels and affects T3 production (Eravci et
al, 2000; Lin et al, 1999; Baumgartner et al, 1994; Shelton
et al, 1993).
In rat brain, fluoxetine has also been
shown to interfere with T3
metabolism (Eravci et al, 2000; Baumgartner et al, 1994).
In 1983 Golstein et al. stated that, "the
major effect of the drug seems to be stimulation of TSH synthesis
and release via the inhibition of T4-mediated thyroid-pituitary
feedback. Additionally, fluoxetine could exert a minor direct
central stimulatory effect on TSH secretion".
The metabolites produced by organic fluoride
compounds in the liver are tranferred to the fetus through
various pathways, including circulatory via placental passage,
gastrointestinal via fetal swallowing, and respiratory secondary
to fetal lung absorption (Hostetter et al, 2000). Numerous
congenital abnormalities have been reported due to first trimester
to Fluconsazole, a systemic antifungal agent (Pursley et al,
Infants who were breastfed by mothers
taking fluoxetine (Prozac)
demonstrated a growth curve significantly below that of infants
who were breastfed by mothers who did not take the drug (Chambers
et al, 1999).
This is of urgent concern. The potential
for severe mental dysfunction is immense.
Most of the fluorinated drugs withdrawn
have shown to cause serious cardiac adverse effects, which
is not surprising considering their influence on thyroid hormone
(Ironically many were first held of benefit
in heart disease).
1) In 2000 Cisapride
("Propulsid") was withdrawn because it caused
severe cardiac side effects
2) The drug Mibedrafil
("Posicor") was withdrawn after it was shown that
patients with congestive heart failure showed a trend to
higher mortality (1998).
was withdrawn in 1993 after it was shown that the beneficial
effects on the symptoms of heart failure did not last beyond
the first 3 months of therapy. After the first 3 months
of therapy, patients on the drug had a higher rate of hospitalization
than patients taking a placebo.
(allergy drug) was withdrawn in 1999 because it also became
associated with serious life threatening cardiac adverse
were withdrawn in 1997 due to serious cardiac adverse health
(Other fluorinated drugs have also shown
serious cardiac toxicity, such as Halofantrine, but remain
on the market with only warnings issued so far.)
(anti-diabetic) was withdrawn in 1997 after the appearance
of severe liver toxicity and deaths.
7) In 1992 Abbott withdrew Temafloxacin
(anti-biotic) ("Omniflox"). The drug had caused
deaths, liver dysfunction, etc.
was removed from the market in 1999 because of serious cardiac
Etc., etc., etc...
This is also what we call - fluoride poisoning.
Schuld, Wendy Small
Parents of Fluoride Poisoned Children (PFPC) -http://www.bruha.com/fluoride/
Vancouver, BC, Canada
PS: Last year,
U.S. District Judge Louis C. Bechtle approved a $3.75 billion
national settlement of health claims stemming from "Fen-Phen".
More than 9,000 lawsuits were filed against American Home
Products, maker of fenfluramine.
Additional comments from Jeff
Green of Citizens
for Safe Drinking Water (phone - 800-728-3833):
One of the most frequently used anesthesias
for general surgery is fluorinated halothane. A finding of
significantly higher incidence of cardiac arrhythmias in children
who were undergoing outpatient dental extraction and who were
anaesthetised with halothane compared with sevoflurane, is
reported on at: http://www.doh.gov.uk/cmo/cmo99_13.htm
For more information, please refer to
References - Fluoride and the Thyroid
References - PFOA/PFOS (Scotchgard)
and Scotchgard: "Heroes of Chemistry" or a 20-year coverup?
Baumgartner A, Dubeyko M, Campos-Barros
A, Eravci M, Meinhold H - "Subchronic administration
of fluoxetine to rats affects triiodothyronine production
and deiodination in regions of the cortex and in the limbic
forebrain" Brain Res 635(1-2):68-74 (1994)
Chambers CD, Anderson PO, Thomas
RG, Dick LM, Felix RJ, Johnson KA, Jones KL - "Weight
gain in infants breastfed by mothers who take fluoxetine"
Pediatrics 104(5):e61 (1999)
Eravci M, Pinna G, Meinhold
H, Baumgartner A - "Effects of pharmacological and nonpharmacological
treatments on thyroid hormone metabolism and concentrations
in rat brain" Endocrinology 141(3):1027-40 (2000)
Friedenberg FK, Rothstein KD
- "Hepatitis secondary to fluoxetine treatment"
Am J Psychiatry 153(4):580(1996)
Golstein J, Schreiber S, Velkeniers
B, Vanhaelst L - "Effect of fluoxetine, a serotonin reuptake
inhibitor, on the pituitary-thyroid axis in rat" Eur
J Pharmacol 91(2-3):239-43 (1983)
Hostetter A, Ritchie JC, Stowe
ZN - "Amniotic fluid and umbilical cord blood concentrations
of antidepressants in three women" Biol Psychiatry 48(10):1032-4
Jackson IM, Luo LG - "Antidepressants
inhibit the glucocorticoid stimulation of
thyrotropin releasing hormone expression in cultured hypothalamic
neurons" J Investig Med 1998 Dec;46(9):470-4 (1988)
Johnston DE, Wheeler DE - "Chronic
hepatitis related to use of fluoxetine." Am J Gastroenterol
Lin X, Levitsky DA, King JM,
Campbell TC - "The promotion effect of anorectic drugs
on aflatoxin B(1)-induced hepatic preneoplastic foci"
Carcinogenesis 20(9):1793-9 (1999)
Mars F, Dumas de la Roque G,
Goissen P - "Acute hepatitis during treatment with fluoxetine"
Gastroenterol Clin Biol 15(3):270-1 (1991)
Pursley TJ, Blomquist IK, Abraham
J, Andersen HF, Bartley JA - "Fluconazole-induced congenital
anomalies in three infants" Clin Infect Dis 22(2):336-40
Shelton RC, Winn S, Ekhatore
N, Loosen PT - "The effects of antidepressants on the
thyroid axis in depression." Biol Psychiatry 33(2):120-6
Be sure to read the other two articles
on Baycol in this week's issue:
Pulled From Market as Numerous Deaths Linked to It
Baycol Recall: How Safe Is Your Statin?
Drugs: How Expensive Is Too Expensive?
Cholesterol Guidelines Issued
May Suppress Your Immune System: There Are Far Better Options