| Halo2 guy 2005-07-12, 11:12 pm |
| GOD damn I am tired of these cross posting trolls.
"Rich Murray" <rmforall@att.net> wrote in message
news:11ctes4d641fmf5@news.supernews.com...
> *************************************************************
>
> http://groups.yahoo.com/group/aspartameNM/message/1180
> 21 years of aspartame (methanol, formaldehyde) toxicity from daily
> Baclofen
> (Schwarz Pharma, Kemstro orally dissolving tablets): FDA info: MaryChris:
> Greg: Murray 2005.07.07
>
> [ These three items are slightly edited for clarity, with more spacing.
> Comments by Rich Murray are in square brackets. I am sending this to the
> Board of Schwarz Pharma, hoping to elicit a creative response that will
> enormously benefit the citizens of our world. ]
>
> From: <MaryChrisW@aol.com>
> To: <gregdude63@hotmail.com>; <aspartame@yahoogroups.com>
> Subject: Re: [Aspartame Support] new to group and can't sleep
> Date: Thursday, July 07, 2005 10:42 AM
>
> When I first started reading Greg's post, I thought I was reading my own
> story. I, too, am 42. Over the last 5 years my symptoms increased from
> abdominal pain, to numbness in face and belly, to memory loss, to ringing
> ears-- to now numbness in my lower extremities.
>
> I read about aspartame poisoning and said, THIS IS ME! Yet I never
> consumed diet pop and ate whole foods. I finally did some digging last
> night
> on the medication I've been prescribed (and taking daily for 21 years)
> and
> sure enough, Aspartame. I was devastated and yet finally I feel I have an
> answer for years of increased suffering and negative test results.
> Unfortunately-- or ironically? -- the drug (Baclofen) is not something you
> can stop cold turkey. There are all kinds of warnings.
>
> I'm supposed to contact my doctor who -- after years of finding nothing
> wrong with me despite my weighing 82 pounds -- treats me like a headcase
> rather than a medical case. I can just imagine his reaction if I suggest
> aspartame is to blame for anything.
>
> Mary
>
>
> From: "gregdude1763" <gregdude63@hotmail.com>
> To: <aspartame@yahoogroups.com>
> Subject: [Aspartame Support] new to group and can't sleep
> Date: Thursday, July 07, 2005 9:28 AM
>
> Hello,
>
> My name is Greg and I am 42 years old. I've been following this
> group off and on for a few years, but lately very much off. About 3
> years ago I started having (more like noticing) symptoms such as
> headaches, depression, blurry vision, muscle sorness, short term
> memory loss, ringing ears, etc. I found this site then and totally
> was amazed and shocked that these problems could be related to
> aspartame. And I knew it was possible since I was drinking about a
> 6 pack a day of diet coke!
>
> Anyway, I managed to get off the diet soda for a while and felt much
> better.
> But after a while, I would inevitably gravitate back to the soda...
> drink tons of it daily, then
> get off of it a while and feel better...then start the cycle all
> over again. After a while, I just started ignoring the symptoms and
> now for the last couple of years I have been back guzzling diet
> sodas. I really think I have a problem...I know the stuff is bad
> for me, but I just can't seem to quit...I don't know why! At work,
> for instance, I love the fresh taste of cool bottled water...but
> here I go to the vending machine for a diet coke!
>
> Anyway, why I am finally asking for encouragement
> (which I should have done 3 years ago),
> is I'm having slightly worsening headaches, muscle soreness
> (exercise seems to be helping lately with that), blurred vision in
> my right eye, loud ringing in ears and, the most disturbing and what
> I'd like to ask about...is sleep apnea (spelling?). This has been
> getting progressively worse, until the last few nites I jump out of
> bed just after falling asleep trying to catch my breath. I
> literally feel like I am dying. It is very scary. It's like there
> is some sort of blockage in my throat, or it's constricted in some
> way...I don't know. That's why I am up now writing this at nearly 3
> am. Anyway, I have to go for a check up to see what could be
> causing this...but is it possible these symptoms could be caused by
> acute aspartame poisening? Even if not, this has got me so scared
> that I am determined to drop the aspertame for good, and I know my
> other symptoms will go away, and maybe it is contributing to the
> apnea in some way.
>
> Thanks for listening...and I look forward to reporting back on my
> progress as I try and detox myself from this retched poison. The
> fist step though, is to get off the stuff cold turkey...which I
> have'nt been able to do. Take it a day at a time as they say. Wish
> me luck...I will need it.
>
> Greg
> ************************************************************
>
>
> "During the last few years SCHWARZ PHARMA has been able to create and move
> forward an impressive development portfolio in neurology and urology
> through
> its Search and Development strategy.
>
> SCHWARZ PHARMA is advancing the development of innovative drugs for the
> treatment of Parkinson's disease, Restless Legs Syndrome (RLS), epilepsy,
> neuropathic pain, overactive bladder syndrome and others."
>
> [ Aspartame reactors commonly report aggravation of all the above
> neurological syndromes. ]
>
> SCHWARZ PHARMA AG
> Alfred-Nobel-Straße 10 Monheim, Germany
> Tel +49 2173 48 - 0 Fax +49 2173 48 -1608 info@schwarzpharma.com
>
> Schwartz Pharma, Inc.
> P.O.Box 2038 Milwaukee, WI 53201
> (800) 558-5114 (262) 238-9994 Fax: 262-238-0311
> dbrennan@schwarzusa.com mleister@schwarzusa.com
>
> Donna K. Multhauf Director, Regulatory Affairs and Quality Assurance
>
> PO. Box 2038 l Milwaukee, WI 53201-2508 l 6140 West Executive Dr. l
> Mequon, WI 53092-4467
> Telephone 262-238-9994 Tollfree 800-558-5114 Fax 262-238-0311
> www.schwarzusa.com
>
> twillard@schwarzusa.com; kveiting@schwarzusa.com;
> patrick.schwarz-schuette@schwarzpharma.com;
> detlef.thielgen@schwarzpharma.com; juergen.baumann@schwarzpharma.com;
> iris.loew-friedrich@schwarzpharma.com
> ************************************************************
>
> http://www.fda.gov/cder/foi/label/2...kemstro_lbl.pdf
>
> "Phenylketonurics
>
> Phenylketonuric patients should be informed that KEMSTRO. contains
> phenylalanine 3.9 mg per 10 mg orally disintegrating tablet and 7.9 mg per
> 20 mg orally disintegrating tablet."
>
> [ Since phenylalanine is 50% of aspartame, the aspartame dose is 7.8 and
> 15.8 mg for these two dose levels of a medicine that dissolves in the
> mouth
> at a level that has been observed to trigger toxic symptoms for aspartame
> reactors.
>
> The 20 mg pill is about the same dose, 15.8 mg aspartame, as three sticks
> of
> chewing gum, 6-8 mg aspartame each, nearly half of a packet of Equal
> tabletop sweetener, 37 mg aspartame.
>
> Aspartame reactors often react immediately and severely to such small
> doses,
> even without knowing they were exposed.
>
> The maximum daily Kemstro dose is 80 mg, with 63.2 mg aspartame, about 10
> sticks of gum, nearly 2 packets of Equal, about a third of a 12-oz can of
> diet soda.
>
> The maximum methanol dose, 11% of the aspartame, is thus 7.0 mg, of which
> a
> large fraction is quickly converted into formaldehyde and then formic
> acid,
> both dire, potent, cumulative toxins. The USA EPA limit for formaldehyde
> in
> drinking water is 1 ppm, which is 2 mg daily for the average use of 2 L
> daily drinking water. The state limit in California is three times more
> stringent, and in Maryland, ten times. So there is remarkable lack of
> consensus and clarity about safety levels for ingested formaldehyde at
> low
> levels for years. ]
>
> "KEMSTRO. is useful for the alleviation of signs and symptoms of
> spasticity
> resulting from multiple sclerosis, particularly for the relief of flexor
> spasms and concomitant pain, clonus, and muscular rigidity.'
>
> [ Aspartame reactors often report headache and many other body pains,
> including aching joints, muscle cramps and spasms, burning sensations, and
> numbness, as well as fatigue, depression, irritability, visual and eye
> problems, poor memory, "brain fog", poor coordination, and so are often
> misdiagnosed as having multiple sclerosis. ]
>
> "CONTRAINDICATIONS
>
> KEMSTRO. is contraindicated in patients who are hypersensitive to any
> component of this product."
>
> "In patients with epilepsy, the clinical state and electroencephalogram
> should be monitored at regular intervals, since deterioration in seizure
> control and EEG have been reported occasionally in patients taking
> baclofen."
>
> [ Hypersensitity, irregular EEGs, and ideopathic seizures are widely
> reported by aspartame reactors.
> Formaldehyde, according to Prof. Martin L. Pall, is a major trigger for
> Multiple Chemical Sensitivity and many similar syndromes. ]
>
> "The central nervous system depressant effects of baclofen may be additive
> to those of alcohol and other CNS depressants.'
>
> [ Dark wines and liquors have about twice the methanol level of the same
> volume of diet soda. Experts state that the main cause of the dreadful
> symptoms of "morning after" hangover are due to formaldehyde produced by
> the
> body from methanol. That is why gin and vodka, with little methanol
> impurity, are well known for not causing hangovers. However, about a
> quarter to a half of those who get inebriated do not get hangovers, so
> there
> are huge individual differences.
>
> In ADVERSE REACTIONS, the long list will be a very familiar litany of
> problems recognizable by aspartame reactors and their informed
> physicians. ]
>
>
> NDA 21-589 Page 5
>
> KEMSTRO.
> (baclofen orally disintegrating tablets)
>
> Rx Only
>
> DESCRIPTION
>
> KEMSTRO. (baclofen orally disintegrating tablets) is a muscle relaxant and
> antispastic.
> Baclofen USP is a white to off-white, odorless or practically odorless
> crystalline powder.
> It is slightly soluble in water, very slightly soluble in methanol, and
> insoluble in chloroform.
> Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.
> The molecular weight of baclofen is 213.66
> and the empirical formula is C10H12C1NO2.
> The structural formula is represented below:
>
> KEMSTRO. is available as 10 mg and 20 mg orally disintegrating tablets.
> Each orally disintegrating tablet also contains as inactive ingredients:
> aspartame,
> colloidal silicon dioxide,
> crospovidone,
> magnesium stearate,
> mannitol,
> microcrystalline cellulose,
> natural and artificial orange flavor and
> povidone.
>
> CLINICAL PHARMACOLOGY
>
> The precise mechanism of action of baclofen is not fully known.
> Baclofen is capable of inhibiting both monosynaptic and polysynaptic
> reflexes at the spinal level,
> possibly by hyperpolarization of afferent terminals,
> although actions at supraspinal sites may also occur
> and contribute to its clinical effect.
>
> Although baclofen is an analog of the putative inhibitory neurotransmitter
> gamma-amino-butyric acid (GABA),
> there is no conclusive evidence that actions on GABA systems are involved
> in
> the production of its clinical effects.
> In studies with animals, baclofen has been shown to have general CNS
> depressant properties as indicated by the production of sedation with
> tolerance, somnolence, ataxia, and respiratory and cardiovascular
> depression.
>
> NDA 21-589 Page 6
>
> Pharmacokinetics
>
> Absorption
>
> Baclofen is rapidly and extensively absorbed.
> Absorption may be dose-dependent,
> being reduced with increasing doses.
> KEMSTROT given with or without water is bioequivalent to the baclofen
> conventional tablet.
> Thus KEMSTROT can be placed on the tongue until it disintegrates and then
> be
> swallowed with or without water.
> Following a single 20 mg oral dose of KEMSTRO., the peak
> plasma concentration was reached about 1½ hours after administration.
>
> Distribution
>
> The apparent volume of distribution is 59 liters.
> Baclofen does not readily cross the blood-brain barrier.
> Plasma protein binding is approximately 30%.
>
> Metabolism
>
> In a study using radiolabeled baclofen, approximately 85% of the dose was
> excreted unchanged in the urine and feces.
> About 15% of the dose was metabolized, primarily by deamination.
> The ã-hydroxy metabolite, 3-(p-chlorophenyl)-4-hydroxybutyric acid,
> is formed after deamination of baclofen.
>
> Excretion
>
> Baclofen is rapidly and extensively eliminated.
> There is a relatively large intersubject variation in elimination.
> Baclofen is excreted primarily by the kidney as unchanged drug;
> 70 - 80% of a dose appears in the urine as unchanged drug.
> The remainder is excreted as unchanged drug in the feces or as metabolites
> in the urine and feces.
> Excretion is complete within 72 hours after administration.
> The elimination half-life of KEMSTRO. is approximately 5½ hours.
> Total systemic clearance is 180 mL/min and renal clearance is 103 mL/min.
>
> Special Populations
>
> Elderly
>
> The pharmacokinetics of baclofen tablets were evaluated in elderly
> patients
> (69-81 years) and in
> healthy younger subjects (23-53 years) after a single 10 mg dose.
> The Cmax was lower (119 ng/mL vs. 178 ng/mL)
> and the Tmax was longer (3 hours vs. 1 hour)
> in the elderly patients compared to the younger subjects.
> The AUCs were similar in the two groups.
> In this study, the elimination half-life was slightly prolonged in the
> elderly patients compared to the younger subjects,
> 4.43 hours vs. 3.75 hours, respectively.
>
> INDICATIONS AND USAGE
>
> KEMSTRO. is useful for the alleviation of signs and symptoms of spasticity
> resulting from multiple sclerosis, particularly for the relief of flexor
> spasms and concomitant pain, clonus, and muscular rigidity.
>
> NDA 21-589 Page 7
>
> Patients should have reversible spasticity so that treatment with KEMSTRO.
> will aid in restoring residual function.
> KEMSTRO. may also be of some value in patients with spinal cord injuries
> and
> other spinal cord diseases.
> KEMSTRO. is not indicated in the treatment of skeletal muscle spasm
> resulting from rheumatic disorders.
> The efficacy of KEMSTRO. in stroke, cerebral palsy, and Parkinson's
> disease
> has not been established and, therefore, it is not recommended for these
> conditions.
>
> CONTRAINDICATIONS
>
> KEMSTRO. is contraindicated in patients who are hypersensitive to any
> component of this product.
>
> WARNINGS
>
> Abrupt Drug Withdrawal
>
> Hallucinations and seizures have occurred on abrupt withdrawal of
> baclofen.
> Therefore, except for serious adverse reactions,
> the dose should be reduced slowly when the drug is discontinued.
>
> Impaired Renal Function
>
> Because baclofen is primarily excreted unchanged by the kidneys,
> it should be given with caution and it may be necessary to reduce the
> dosage
> in patients with impaired renal function.
>
> Stroke
>
> Baclofen has not significantly benefited patients with stroke. These
> patients have also shown poor tolerability to the drug.
>
> PRECAUTIONS
>
> General
>
> Baclofen should be used with caution where spasticity is utilized to
> sustain
> upright posture and balance in locomotion or whenever spasticity is
> utilized
> to obtain increased function.
>
> In patients with epilepsy, the clinical state and electroencephalogram
> should be monitored at regular intervals, since deterioration in seizure
> control and EEG have been reported occasionally in patients taking
> baclofen.
>
> Information for Patients
>
> Because of the possibility of sedation,
> patients should be cautioned regarding the operation of automobiles or
> other
> dangerous machinery, and activities made hazardous by decreased alertness.
> Patients should also be cautioned that the central nervous system
> depressant
> effects of baclofen may be additive to those of alcohol and other CNS
> depressants.
>
> Phenylketonurics
>
> Phenylketonuric patients should be informed that KEMSTRO. contains
> phenylalanine 3.9 mg per 10 mg orally disintegrating tablet and 7.9 mg per
> 20 mg orally disintegrating tablet.
>
> NDA 21-589 Page 8
>
> Drug Interactions
>
> The central nervous system depressant effects of baclofen may be additive
> to
> those of alcohol and other CNS depressants.
>
> Carcinogenesis, Mutagenesis, Impairment of Fertility
>
> A dose-related increase in incidence of ovarian cysts and a less marked
> increase in enlarged and/or hemorrhagic adrenal glands was observed in
> female rats treated chronically with baclofen.
>
> Ovarian cysts have been found by palpation in about 4% of the multiple
> sclerosis patients that were treated with baclofen for up to one year.
> In most cases these cysts disappeared spontaneously while patients
> continued
> to receive the drug.
> Ovarian cysts are estimated to occur spontaneously in approximately 1% to
> 5%
> of the normal female population.
>
> Pregnancy
>
> Pregnancy Category C.
>
> Baclofen has been shown to increase the incidence of omphaloceles (ventral
> hernias) in fetuses of rats given approximately 13 times the maximum dose
> recommended for human use,
> at a dose which caused significant reductions in food intake and weight
> gain
> in dams.
> This abnormality was not seen in mice or rabbits.
> There was also an increased incidence of incomplete sternebral
> ossification
> in fetuses of rats given approximately 13 times the maximum recommended
> human dose,
> and an increased incidence of unossified phalangeal nuclei of forelimbs
> and
> hindlimbs in fetuses of rabbits given approximately 7 times the maximum
> recommended human dose.
> In mice, no teratogenic effects were observed,
> although reductions in mean fetal weight with consequent delays in
> skeletal
> ossification were present when dams were given 17 or 34 times the human
> daily dose.
> There are no adequate and well-controlled studies in pregnant women.
>
> KEMSTRO. should be used during pregnancy only if the potential benefit
> justifies the potential risk to the fetus.
>
> Nursing Mothers
>
> It is not known whether this drug is excreted in human milk.
> Because many drugs are excreted in human milk,
> caution should be exercised when KEMSTRO. is administered to a nursing
> woman.
>
> Pediatric Use
>
> Safety and effectiveness in pediatric patients below the age of 12 have
> not
> been established.
>
> Geriatric Use
>
> Clinical studies of baclofen did not include sufficient numbers of
> subjects
> aged 65 and over to determine whether they respond differently from
> younger
> subjects.
> In general, dose selection for an elderly patient should be cautious,
> usually starting at the low end of the dosing range, reflecting the
> greater
> frequency of decreased hepatic, renal, or cardiac function, and of
> concomitant disease or other drug therapy.
> This drug is known to be substantially excreted by the kidney, and the
> risk
> of toxic reactions to this drug may be greater in patients with impaired
> renal function.
> Because elderly patients are more likely to have decreased renal function,
> care should be taken in dose selection, and it may be useful to monitor
> renal function.
> Sedating drugs may cause confusion and over-sedation in the elderly;
> elderly
> patients generally should be started on low doses of KEMSTRO. and observed
> closely.
>
> NDA 21-589 Page 9
>
> ADVERSE REACTIONS
>
> The most common adverse reaction during treatment with baclofen is
> transient
> drowsiness (10-63%).
> In one controlled study of 175 patients, transient drowsiness was observed
> in 63% of those receiving baclofen tablets compared to 36% of those in the
> placebo group.
>
> Other common adverse reactions are dizziness (5-15%), weakness (5-15%) and
> fatigue (2-4%).
>
> Others reported:
>
> Neuropsychiatric:
>
> Confusion (1-11%),
> headache (4-8%),
> insomnia (2-7%);
> and, rarely, euphoria, excitement, depression, hallucinations,
> paresthesia,
> muscle pain, tinnitus, slurred speech, coordination disorder, tremor,
> rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis,
> mydriasis, diplopia, dysarthria, epileptic seizure.
>
> Cardiovascular:
>
> Hypotension (0-9%).
> Rare instances of dyspnea, palpitation, chest pain, syncope.
>
> Gastrointestinal:
>
> Nausea (4-12%),
> constipation (2-6%);
> and, rarely, dry mouth, anorexia, taste disorder, abdominal pain,
> vomiting,
> diarrhea, and positive test for occult blood in stool.
>
> Genitourinary:
>
> Urinary frequency (2-6%); and, rarely, enuresis, urinary retention,
> dysuria,
> impotence, inability to ejaculate, nocturia, hematuria.
>
> Other:
>
> Instances of rash, pruritus, ankle edema, excessive perspiration, weight
> gain, nasal congestion.
> Some of the CNS and genitourinary symptoms may be related to the
> underlying
> disease rather than to drug therapy.
> The following laboratory tests have been found to be abnormal in a few
> patients
> receiving baclofen:
> increased SGOT,
> elevated alkaline phosphatase,
> and elevation of blood sugar.
> The adverse experience profile seen with KEMSTROT was similar to that seen
> with baclofen tablets.
>
> OVERDOSAGE
>
> Signs and Symptoms
>
> Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma,
> respiratory depression, and seizures.
>
> Treatment
>
> In the alert patient, empty the stomach promptly by induced emesis
> followed
> by lavage.
> In the obtunded patient, secure the airway with a cuffed endotracheal tube
> before beginning lavage (do not induce emesis).
> Maintain adequate respiratory exchange,
> do not use respiratory stimulants.
> It is unknown what effect hemodialysis or peritoneal dialysis has on the
> serum concentration of baclofen.
>
> DOSAGE AND ADMINISTRATION
>
> The determination of optimal dosage requires individual titration.
> Start therapy at a low dosage and increase gradually until optimum effect
> is
> achieved (usually between 40-80 mg daily).
>
> The following dosage titration schedule is suggested:
> 5 mg three times a day for 3 days
> 10 mg three times a day for 3 days
> 15 mg three times a day for 3 days
> 20 mg three times a day for 3 days
>
> NDA 21-589 Page 10
>
> Thereafter additional increases may be necessary but the total daily dose
> should not exceed a maximum of 80 mg daily (20 mg four times a day).
>
> The lowest dose compatible with an optimal response is recommended. If
> benefits are not evident after a reasonable trial period, patients should
> be
> slowly withdrawn from the drug (see WARNINGS, brupt Drug Withdrawal).
>
> Administration
>
> Using dry hands, the patient should be instructed to place the tablet on
> the
> tongue, where it will disintegrate and can then be swallowed with or
> without
> water.
>
> Patients with Renal Impairment
>
> Because baclofen is primarily excreted unchanged by the kidneys,
> it should be given with caution and it may be necessary to reduce the
> dosage
> in patients with impaired renal function.
>
> HOW SUPPLIED
>
> KEMSTRO. (baclofen orally disintegrating tablets) 10 mg are white, round,
> orange-flavored, scored and engraved "10" on the unscored side and "SP"
> above and "351" below the score on the other side.
>
> They are supplied as follows:
> Bottles of 100 NDC 0091-3351-01
>
> KEMSTRO. (baclofen orally disintegrating tablets) 20 mg are white, round,
> orange-flavored, scored and engraved "20" on the unscored side and "SP"
> above and "352" below the score on the other side.
>
> They are supplied as follows:
> Bottles of 100 NDC 0091-3352-01
>
> Dispense in a tight container as defined in the USP/NF with a
> child-resistant closure.
>
> Store at controlled room temperature 20° - 25°C (68° - 77°F);
> excursions permitted between 15° - 30°C (59° - 86°F). Protect from
> moisture.
>
> Manufactured for:
> SCHWARZ PHARMA Milwaukee, WI 53201, USA
> By: CIMA. Eden Prairie, MN 55344, USA
> KEMSTRO. uses CIMA U.S. Patent Nos. 6,024,981 and 6,221,392.
> ************************************************************
>
> Rich Murray, MA Room For All rmforall@comcast.net 505-501-2298
> 1943 Otowi Road Santa Fe, New Mexico 87505 USA
> http://groups.yahoo.com/group/aspartameNM/messages
> group with 185 members, 1,181 posts in a public, searchable archive
>
> http://groups.yahoo.com/group/aspartameNM/message/1165
> short review: research on aspartame (methanol, formaldehyde, formic acid)
> toxicity: Murray 2005.07.06 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/1071
> research on aspartame (methanol, formaldehyde, formic acid) toxicity:
> Murray
> 2004.04.29 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/1143
> methanol (formaldehyde, formic acid) disposition: Bouchard M et al, full
> plain text, 2001: substantial sources are degradation of fruit pectins,
> liquors, aspartame, smoke: Murray 2005.04.02 rmforall
>
> Fully 11% of aspartame is methanol-- 1,120 mg aspartame in 2 L diet
> soda,
> almost six 12-oz cans, gives 123 mg methanol (wood alcohol). If 30% of
> the methanol is turned into formaldehyde, the amount of formaldehyde is 18
> times the USA EPA limit for daily formaldehyde in drinking water, 2 mg in
> 2
> L water.
>
>
> http://groups.yahoo.com/group/aspartameNM/message/846
> aspartame in Merck Maxalt-MLT worsens migraine,
> AstraZeneca Zomig, Eli Lilly Zyprexa,
> J&J Merck Pepcid AC (Famotidine 10mg) Chewable Tab,
> Pfizer Cool Mint Listerine Pocketpaks: Murray 2002.07.16 rmforall
>
> Migraine MLT-Down: an unusual presentation of migraine
> in patients with aspartame-triggered headaches.
> Newman LC, Lipton RB Headache 2001 Oct; 41(9): 899-901.
> [ Merck 10-mg Maxalt-MLT, for migraine, has 3.75 mg aspartame,
> while 12 oz diet soda has 200 mg. ]
> Headache Institute, St. Lukes-Roosevelt Hospital Center, New York, NY
> Department of Neurology newmanache@aol.com
> Albert Einstein college of Medicine, Bronx, NY
> Innovative Medical Research RLipton@IMRInc.com
>
> http://groups.yahoo.com/group/aspartameNM/message/855
> Blumenthall & Vance: aspartame chewing gum headaches Nov 1997:
> Murray 2002.07.28 rmforall
>
> Harvey J. Blumenthal, MD, Dwight A Vance, RPh
> Chewing Gum Headaches. Headache 1997 Nov-Dec; 37(10): 665-6.
> Department of Neurology, university of Oklahoma college of Medicine,
> Tulsa, USA. neurotulsa@aol.com
> Aspartame, a popular dietetic sweetener, may provoke headache in some
> susceptible individuals. Herein, we describe three cases of young women
> with migraine who reported their headaches could be provoked by chewing
> gum sweetened with aspartame. [ 6-8 mg aspartame per stick chewing gum ]
>
> http://groups.yahoo.com/group/aspartameNM/message/782
> RTM: Smith, Terpening, Schmidt, Gums:
> full text: aspartame, MSG, fibromyalgia 2002.01.17 rmforall
> Jerry D Smith, Chris M Terpening, Siegfried OF Schmidt, and John G Gums
> Relief of Fibromyalgia Symptoms Following
> Discontinuation of Dietary Excitotoxins.
> The Annals of Pharmacotherapy 2001; 35(6): 702-706.
> Malcolm Randall Veterans Affairs Medical Center, Gainesville, FL, USA.
> BACKGROUND: Fibromyalgia is a common rheumatologic disorder that is
> often difficult to treat effectively.
> CASE SUMMARY: Four patients diagnosed with fibromyalgia syndrome
> for two to 17 years are described.
> All had undergone multiple treatment
> modalities with limited success. All had complete, or nearly complete,
> resolution of their symptoms within months after eliminating monosodium
> glutamate (MSG) or MSG plus aspartame from their diet.
> All patients were women with multiple comorbidities
> prior to elimination of MSG.
> All have had recurrence of symptoms whenever MSG is ingested.
>
> Siegfried O. Schmidt, MD Asst. Clinical Prof. siggy@shands.ufl.edu
> Community Health and Family Medicine, U. Florida, Gainesville, FL
> Shands Hospital West Oak Clinic Gainesville, FL 32608-3629
> 352-376-5071
>
>
>
> Aspartame (NutraSweet, Equal, Canderel, E951), after eight years of
> controversy, was suddenly and capriciously approved by a new FDA
> commissioner, Arthur Hull Hayes, Jr, just appointed by President Reagan,
> a
> pharmacologist who had been in office less than three months and had
> little
> background in food additives, in July 1981, overturning the vote of his
> own
> Scientific Board of Inquiry.
>
> Aspartame is made of phenylalanine (50% by weight) and aspartic acid
> (39%),
> both ordinary amino acids, bound loosely together by methanol (wood
> alcohol,
> 11%). The readily released methanol from aspartame is within hours
> turned
> by the liver into formaldehyde and then formic acid, both potent,
> cumulative
> toxins.
>
> A team in a Searle Co. lab, led by J.A. Oppermann, proved that 30% of the
> methanol in aspartame fed to rats remained, indubitably as toxic products
> of
> formaldehyde and formic acid in all tissues (1973, 1976).
>
> http://groups.yahoo.com/group/aspartameNM/message/925
> aspartame puts formaldehyde adducts into tissues, Part 1/2
> full text, Trocho & Alemany 1998.06.26: Murray 2002.12.22 rmforall
>
> This was confirmed by an expert team at the university of Barcelona
> (Trocho,
> Alemany et al, 1998):
> "...the binding of methanol-derived carbon to tissue proteins was
> widespread, affecting all systems, fully reaching even sensitive targets
> such as the brain and retina...These are indeed extremely high levels for
> adducts of formaldehyde, a substance responsible for chronic deleterious
> effects (33), that has also been considered carcinogenic (33,47)."
>
> http://groups.yahoo.com/group/aspartameNM/message/1016
> President Bush & formaldehyde (aspartame) toxicity: Ramazzini Foundation
> carcinogenicity results Dec 2002: Soffritti: Murray 2003.08.03 rmforall
>
> p. 88 "The sweetening agent aspartame hydrolyzes in the gastrointestinal
> tract to become free methyl alcohol, which is metabolized in the liver to
> formaldehyde, formic acid, and CO2. (11)"
> Medinsky MA & Dorman DC. 1994; Assessing risks of low-level methanol
> exposure. CIIT Act. 14: 1-7.
> Ann N Y Acad Sci. 2002 Dec; 982: 87-105.
> Results of long-term experimental studies on the carcinogenicity of
> formaldehyde and acetaldehyde in rats. M. Soffritti et al. Cancer
> Research Center, European Ramazzini Foundation for Oncology and
> Environmental Sciences, Bologna, Italy. crcfr@tin.it
>
> http://groups.yahoo.com/group/aspartameNM/message/1077
> eight depressed people react strongly to aspartame, Prof. Ralph G. Walton,
> MD, 1993 double-blind study, full text: Murray 2004.04.26 rmforall
> Despite the very small number of subjects, the results were dramatic and
> statistically significant. The eight depressed patients reported with
> aspartame, compared to placebo, much higher levels of nervousness, trouble
> remembering, nausea, depression, temper, and malaise.
>
> Many scientific studies and case histories report: * headaches * many
> body
> and joint pains (or burning, tingling, tremors, twitching, spasms, cramps,
> stiffness, numbness, difficulty swallowing) * fever, fatigue, swollen
> glands * "mind fog", "feel unreal", poor memory, confusion, anxiety,
> irritability, depression, mania, insomnia, dizziness, slurred speech,
> sexual
> problems, poor vision, hearing (deafness, tinnitus), or taste * red
> face,
> itching, rashes, allergic dermatitis, hair loss, burning eyes or throat,
> dry
> eyes or mouth, mouth sores, burning tongue * obesity, bloating, edema,
> anorexia, poor appetite or excessive hunger or thirst * breathing
> problems, shortness of breath * nausea, diarrhea or constipation *
> coldness
> * sweating * racing heart, low or high blood pressure, erratic blood
> sugar
> levels * hypothryroidism or hyperthyroidism * seizures * birth defects
> * brain cancers * addiction * aggrivates diabetes, autism, allergies,
> lupus, ADHD, fibromyalgia, chronic fatigue syndrome, multiple chemical
> sensitivity, multiple sclerosis, pseudotumor cerebri and interstitial
> cystitis (bladder pain).
>
> http://groups.yahoo.com/group/aspartameNM/message/927
> Donald Rumsfeld, 1977 head of Searle Corp., got aspartame FDA approval:
> Turner: Murray 2002.12.23 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/1045
> http://www.holisticmed.com/aspartam...02-response.htm
> Mark Gold exhaustively critiques European Commission Scientific Committee
> on Food re aspartame ( 2002.12.04 ): 59 pages, 230 references
>
> http://groups.yahoo.com/group/aspartameNM/message/1131
> genotoxicity of aspartame in human lymphocytes 2004.07.29 full plain text,
> Rencuzogullari E et al, Cukurova University, Adana, Turkey 2004 Aug:
> Murray
> 2004.11.06 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/1088
> Murray, full plain text & critique: chronic aspartame in rats affects
> memory, brain cholinergic receptors, and brain chemistry, Christian B,
> McConnaughey M et al, 2004 May: 2004.06.05 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/1067
> eyelid contact dermatitis by formaldehyde from aspartame, AM Hill & DV
> Belsito, Nov 2003: Murray 2004.03.30 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/1155
> continuing aspartame debate in British Medical Journal, John Biffra, Bob
> Dowling, Nick Finer, Ian J Gordon: Murray 2005.02.09 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/1065
> politicians and celebrities hooked on diet sodas (aspartame): Murray
> 2004.03.24 rmforall
>
> http://google.com gives 585,000 websites for "aspartame" , with the top 7
> of 10 listings being anti-aspartame, while
> http://www.ncbi.nlm.nih.gov/PubMed lists 786 aspartame items.
> ************************************************************
>
> Additional material:
>
> http://groups.yahoo.com/group/aspartameNM/message/835
> ATSDR: EPA limit 1 ppm formaldehyde in drinking water July 1999:
> Murray 2002.05.30 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/915
> formaldehyde toxicity: Thrasher & Kilburn: Shaham: EPA: Gold:
> Wilson: CIIN: Murray 2002.12.12 rmforall
>
> Thrasher (2001): "The major difference is that the Japanese demonstrated
> the incorporation of FA and its metabolites into the placenta and fetus.
> The quantity of radioactivity remaining in maternal and fetal tissues
> at 48 hours was 26.9% of the administered dose." [ Ref. 14-16 ]
>
> Arch Environ Health 2001 Jul-Aug; 56(4): 300-11.
> Embryo toxicity and teratogenicity of formaldehyde. [100 references]
> Thrasher JD, Kilburn KH. toxicology@drthrasher.org
> Sam-1 Trust, Alto, New Mexico, USA.
> http://www.drthrasher.org/formaldeh...o_toxicity.html full text
>
> http://www.drthrasher.org/formaldehyde_1990.html full text Jack Dwayne
> Thrasher, Alan Broughton, Roberta Madison. Immune activation and
> autoantibodies in humans with long-term inhalation exposure to
> formaldehyde.
> Archives of Environmental Health. 1990; 45: 217-223. "Immune activation,
> autoantibodies, and anti-HCHO-HSA antibodies are associated with long-term
> formaldehyde inhalation." PMID: 2400243
>
>
> http://groups.yahoo.com/group/aspartameNM/message/864
> Butchko, Tephly, McMartin: Alemany: aspartame formaldehyde
> adducts in rats: Murray 2002.09.08 rmforall
> Prof. Alemany vigorously affirms the validity of the Trocho study
> against criticism:
> Butchko, HH et al [24 authors], Aspartame: review of safety.
> Regul. Toxicol. Pharmacol. 2002 April 1; 35 (2 Pt 2): S1-93, review
> available for $35, [an industry paid organ]. Butchko:
> "When all the research on aspartame, including evaluations in both the
> premarketing and postmarketing periods, is examined as a whole, it is
> clear that aspartame is safe, and there are no unresolved questions
> regarding its safety under conditions of intended use."
>
> In the same report, Schiffman concludes on page S49, not citing any
> research after 1997, "Thus, the weight of the scientific evidence
> indicates that aspartame does not cause headache."
> Dr. Susan S. Schiffman, Dept. of Psychiatry, Duke University
> sss@acpub.duke.edu 919-684-3303, 660-5657
>
> http://groups.yahoo.com/group/aspartameNM/message/911
> RTP ties to industry criticized by CSPI: Murray: 2002.12.09 rmforall
>
> Finally, an intripid and much published team in Japan has found DNA damage
> in 8 tissues from single non-lethal doses of aspartame (near-significant
> high levels of DNA damage in 5 tissues) and many other additives in groups
> of just 4 mice:
>
> Mutat Res 2002 Aug 26; 519(1-2): 103-19
> The comet assay with 8 mouse organs: results with 39 currently used food
> additives.
> Sasaki YF, Kawaguchi S, Kamaya A, Ohshita M, Kabasawa K, Iwama K,
> Taniguchi K, Tsuda S.
> Laboratory of Genotoxicity, Faculty of Chemical and Biological
> Engineering, Hachinohe National college of Technology,
> Tamonoki Uwanotai 16-1, Aomori 039-1192, Japan.
> yfsasaki-c@hachinohe-ct.ac.jp s.tsuda@iwate-u.ac.jp
>
> We determined the genotoxicity of 39 chemicals currently in use as food
> additives.
> They fell into six categories-dyes, color fixatives and
> preservatives, preservatives, antioxidants, fungicides, and sweeteners.
>
> We tested groups of four male ddY mice once orally with each additive at
> up to 0.5xLD(50) or the limit dose (2000mg/kg) and performed the comet
> assay on the glandular stomach, colon, liver, kidney, urinary bladder,
> lung,
> brain, and bone marrow 3 and 24 h after treatment.
>
> Of all the additives, dyes were the most genotoxic.
> Amaranth, Allura Red, New Coccine, Tartrazine, Erythrosine, Phloxine, and
> Rose Bengal induced dose-related DNA damage
> in the glandular stomach, colon and/or urinary bladder.
> All seven dyes induced DNA damage in the gastrointestinal organs at a low
> dose (10 or 100mg/kg).
>
> Among them, Amaranth, Allura Red, New Coccine, and Tartrazine induced
> DNA damage in the colon at close to the acceptable daily intakes (ADIs).
>
> Two antioxidants (butylated hydroxyanisole (BHA) and butylated
> hydroxytoluene (BHT)), three fungicides (biphenyl, sodium
> o-phenylphenol, and thiabendazole), and four sweeteners (sodium
> cyclamate, saccharin, sodium saccharin, and sucralose) also induced DNA
> damage in gastrointestinal organs.
>
> Based on these results, we believe that more extensive assessment of
> food additives in current use is warranted. PMID: 12160896
>
> http://groups.yahoo.com/group/aspartameNM/message/934
> 24 recent formaldehyde toxicity [Comet assay] reports:
> Murray 2002.12.31 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/935
> Comet assay finds DNA damage from sucralose, cyclamate, saccharin in
> mice: Sasaki YF & Tsuda S Aug 2002: Murray 2003.01.01 rmforall
> [ Also borderline evidence, in this pilot study of 39 food additives,
> using test groups of 4 mice, for DNA damage from for stomach, colon,
> liver, bladder, and lung 3 hr after oral dose of 2000 mg/kg aspartame--
> a very high dose.]
>
> http://groups.yahoo.com/group/aspartameNM/message/961
> genotoxins, Comet assay in mice: Ace-K, stevia fine; aspartame poor;
> sucralose, cyclamate, saccharin bad: Y.F. Sasaki Aug 2002:
> Murray 2003.01.27 rmforall [A detailed look at the data] ]
>
> http://groups.yahoo.com/group/aspartameNM/message/857
> www.dorway.com: original documents and long reviews of flaws in
> aspartame toxicity research: Murray 2002.07.31 rmforall
>
> http://groups.yahoo.com/group/aspartameNM/message/858
> Samuels: Strong: Roberts: Gold: flaws in double-blind studies re
> aspartame and MSG toxicity: Murray 2002.08.01 rmforall
>
> "Survey of aspartame studies: correlation of outcome and funding
> sources," 1998, unpublished: http://www.dorway.com/peerrev.html
> Walton found 166 separate published studies in the peer reviewed
> medical literature, which had relevance for questions of human safety.
> The 74 studies funded by industry all (100%) attested to aspartame's
> safety, whereas of the 92 non-industry funded studies, 84 (91%)
> identified a problem. Six of the seven non-industry funded studies
> that were favorable to aspartame safety were from the FDA, which
> has a public record that shows a strong pro-industry bias.
> Ralph G. Walton, MD, Prof. of Clinical Psychology, Northeastern Ohio
> Universities, college of Medicine, Dept. of Psychiatry, Youngstown,
> OH 44501, Chairman, The Center for Behavioral Medicine,
> Northside Medical Center, 500 Gypsy Lane, P.O. Box 240 Youngstown,
> OH 44501 330-740-3621 rwalton193@aol.com
> http://www.neoucom.edu/DEPTS/Psychiatry/walton.htm
>
> http://groups.yahoo.com/group/aspartameNM/message/622
> Gold: Koehler: Walton: Van Den Eeden: Leon:
> aspartame toxicity: Murray 2001.06.04 rmforall four double-blind studies
>
> Headache 1988 Feb; 28(1): 10-4
> The effect of aspartame on migraine headache.
> Koehler SM, Glaros A PMID: 3277925, UI: 88138777
> Shirley M. Koehler, PhD 904-858-7651 skoehler@brookshealth.org
> http://www.med.umich.edu/abcn/alpha...-K.html#Koehler
> Alan Glaros glarosa@umkc.edu 816-235-2074
>
> They conducted a double-blind study of patients, ages 18-55, who had
> a medical diagnosis of classical migraines (normally having 1-3
> migraines in 4-weeks), who were not on medications (other than
> analgesics), and who suspected that aspartame had a negative effect on
> their migraine headaches. The subjects were given 1200 mg daily,
> aspartame or placebo, for four weeks, about 17 mg/kg. The placebo
> group had no increase in headaches. Approximately half of the subjects
> (5 of 11) who took aspartame had a large, statistically significant
> (p = 0.02), increase in migraine headache frequency, but not in
> intensity or duration, compared to baseline or placebo. Only 11 of
> 25 subjects completed the program: 8 dropped out, 4 began new
> medications, 2 had incomplete records. They were at home.
> Since 1/3 of the subjects dropped out, they may have been choosing
> to avoid headaches-- were they unpaid? To achieve statistical
> signifance with only 11 subjects hints that the incidence rate from
> aspartame is very high, about 1/2, for migraine cases who believe
> that they are hurt by aspartame.
>
> http://groups.yahoo.com/group/aspartameNM/message/1077
> eight depressed people react strongly to aspartame, Prof. Ralph G. Walton,
> MD, 1993 double-blind study, full text: Murray 2004.04.26 rmforall
>
> Walton, RG, "Adverse reactions to aspartame: double-blind challenge in
> patients from a vulnerable population," 1993, with Robert Hudak and
> Ruth J. Green-Waite, Biological Psychiatry, 34 (1), 13-17.
> Ralph G. Walton, MD, Prof. of Clinical Psychology, Northeastern Ohio
> Universities, college of Medicine, Dept. of Psychiatry, Youngstown,
> OH 44501, Chairman, The Center for Behavioral Medicine,
> Northside Medical Center, 500 Gypsy Lane, P.O. Box 240 Youngstown,
> OH 44501 330-740-3621 rwalton193@aol.com
> http://www.neoucom.edu/DEPTS/Psychiatry/walton.htm
>
> Eight depressed patients, ages 24-60, and five non-depressed controls,
> ages 24-56, employed at the hospital, were given for 7 days either
> aspartame or a placebo, and then after a 3 day break, given the
> opposite. Each got 2100 mg aspartame daily, 30 mg/kg bodyweight,
> equal to 10-12 cans of diet soda daily, about a gallon. Despite the
> very small number of subjects, the results were dramatic and
> statistically significant. The eight depressed patients reported with
> aspartame, compared to placebo, much higher levels of nervousness,
> trouble remembering, nausea, depression, temper, and malaise. (For each
> symptom, p<0.01) The five normals did not report strong enough
> differences between aspartame and placebo to be significant.
> Initially, the study was to be on a group of 40, but was halted by the
> Institutional Review Board because of severe reactions among 3 of the
> depressed patients.
>
> Again, statistical significance with only 8 depressed patients:
> "In this study, patients most often began to report significant
> symptoms after day 2 or 3." The incidence rate is very high,
> indeed, about 1/3. The most common symptoms are entirely typical
> of thousands of case histories.
>
> Stephen K. Van Den Eeden, T.D. Koepsell, W.T. Longstreth, Jr,
> G. van Belle, J.R. Daling, B. McKnight, "Aspartame ingestion and
> headaches: a randomized crossover trial," 1994, Neurology, 44, 1787-93
> Steven K. Van Den Eeden,PhD 550-450-2202 skv@dor.kaiser.org
> Division of Research, Kaiser Permanente Medical Care Program
> 3505 Broadway, Oakland, CA 94611-5714
> http://www.dor.kaiser.org/dorhtml/i..._Den_Eeden.html
>
> In their introduction, they comment:
>
> "In addition, the FDA had received over 5,000 complaints as of July,
> 1991 in a passive surveillance system to monitor adverse side effects.
> (17) Neurologic problems constitute the primary complaints in these
> and several other case series, with headaches accounting for
> 18 to 45 %,depending on the case series reported. (17-19)"
>
> Subjects, ages 18-57, were recruited who believed they got headaches
> from aspartame, but were otherwise mentally and physically healthy.
> They were paid $ 15 total, and were at home. Of the 44 subjects, 32
> contributed data to the 38-day trials: a week of inert placebo, a week
> of either aspartame or placebo, followed by a week of the opposite, and
> then this two-week cycle repeated. The daily dose was about 30 mg/kg.
> "The proportion of days subjects reported having a headache was
> higher during aspartame treatment compared with placebo treatment
> (aspartame = 0.33, placebo = 0.24; p = 0.04) (table 5)".
> Of the 12 subjects not included in the data, 7 reported adverse
> symptoms before withdrawing.
>
> Again, statistical significance with a moderate number of healthy
> subjects, willing to be recruited by a newspaper ad, who believed
> aspartame hurt them. The number of headaches for each subject
> for each treatment week are given: it appears that 4 subjects
> had the strongest increase in headaches from the run-in week
> or placebo week to their first week on aspartame, jumping from 0 to 5,
> 1 to 6, 1 to 4, 0 to 5 headaches per week. So, about 4 of the 44
> healthy people recruited for the study, who believed aspartame hurt
> them, had a stong increase in headaches from the first week of daily
> asparame exposure, while 7 reported adverse symptoms before leaving,
> a total of 11 out of 44, an incidence ratio of 1/4.
>
> This is sky high, if we consider that, if the incidence ratio for the
> about two hundred million users in the USA is 1 of 100, that is 2
> million cases. It is plausible that the incidence ratio lies between 1
> and 10 out of 100 for continuous daily exposure. These three flames
> should have set off alarm bells, with extensive follow-up studies and
> much more careful study of thousands of case histories. But these
> little flares were adroitly smothered by thick blankets of industry
> funded fluff:
>
> http://groups.yahoo.com/group/aspartameNM/message/623
> Simmons: Gold: Schiffman: Spiers:
> aspartame toxicity: Murray 2001.06.04 rmforall two double-blind studies
> *************************************************************
>
> 5. Robert Hickey Aug 24 2001, 11:30 am
> Newsgroups: alt.support.mult-sclerosis
> From: Robert Hickey rob...@bellsouth.net
> Date: Fri, 24 Aug 2001 10:35:00 -0500
> Subject: Re: Baclofen?
>
> jp wrote:
>
>
> My only experiences with Baclofen made we unacceptably weak. I took it
> *many* years ago when I was just recently diagnosed (what was the doc
> thinking? I was about 98% "normal" and had no walking problems) and I
> got around fine. After taking Baclofen for a few days (and at a rather
> small dose) I found myself walking worse than before I took it. I also
> couldn't stand for very long and felt a bit groggy. I don't like or use
> Baclofen. It really disagrees with me.
>
>
> 6. John O'Brien Aug 25 2001, 1:05 pm
> Newsgroups: alt.support.mult-sclerosis
> From: "John O'Brien" obri...@sky.net
> Date: Sat, 25 Aug 2001 12:02:07 -0500
> Local: Sat, Aug 25 2001 1:02 pm
> Subject: Re: Baclofen?
>
> I also echo Robert's experience with Baclofen. I think it's
> the worst thing that can happen to "us". Shame on the neurologists for
> using it. It put me in a wheelchair for a couple years till I figured out
> what was happening to me.
> John
> *************************************************************
>
>
>
>
>
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