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Tylenol Info

 
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PostPosted: Dec Thu 14, 2006 1:06 pm    Post subject: Tylenol Info Reply with quote

Tylenol Info

Acetaminophen (Tyelnol, Calpol, etc)

Statement on Safety Issues Related to Acetaminophen Before the Nonprescription Drugs Advisory Committee (HRG Publication #1639)

Peter Lurie, MD, MPH Deputy Director, Public Citizen's Health Research Group

Statement on Safety Issues Related to Acetaminophen Before the Nonprescription Drugs Advisory Committee September 19, 2002

In 1977, the Food and Drug Administration's (FDA's) Advisory Review Panel recommended the following warnings for acetaminophen-containing products: "Do not exceed recommended dosage because severe liver damage may occur" and "Do not exceed recommended dosage or take for more than 10 days, because severe liver damage may occur." The FDA chose to ignore this wise advice.

A quarter of a century later we are facing an epidemic of fatal acetaminophen- associated poisonings: a near doubling from 76 in 1995 to 141 in 1999, according to data collected by the American Association of Poison Control Centers through its Toxic Exposure Surveillance System (TESS. TESS data also show 108,102 calls to Poison Control Centers in 1999, while data from the National Hospital Ambulatory Care Survey (NHAMCS) show an average of 56,680 Emergency Department Visits per year. The National Hospital Discharge Survey (NHDS) indicates that there are an average of 26,256 hospitalizations per year related to acetaminophen overdoses. Although the TESS data best indicate the time trend for acetaminophen-related mortality, the best estimate of the average number of deaths per year related to acetaminophen is 458, according to death certificate data. Acetaminophen is the leading cause of toxic drug ingestions in the U.S. By any measure, this is a major national health problem.

The FDA has estimated that between at least 57% and 74% of ingestions are intentional, yet the issue before this Committee is described as "Unintentional Acetaminophen Hepatotoxicity," an illogical restriction of the debate and seemingly a capitulation to the notion that nothing can be done for those making suicide attempts. This ignores the facts that many suicide attempts are impulsive "cries for help" (but may nonetheless be fatal), most are not fatal (but may leave significant residual disability), and fatality rates are related to doses consumed.

In fact, many countries have sought to address the problem of suicides or "intentional overdoses." A recent experiment of this kind in the United Kingdom, implemented in September 1998, restricted the number of acetaminophen tablets per pack to 16 in supermarkets and 32 in pharmacies. (Much of this was accomplished through the use of blister packs.) Although one can buy several packs, prescriptions are required to obtain more than 100 tablets. Early evaluations of the program show decreases in total and severe acetaminophen overdoses as well as decreases in acetaminophen-overdose liver transplants and deaths (Prince, et al. Lancet
2000;355:2047-8; Turvill, et al. Lancet 2000;355:2048-9; Robinson, et al. BMJ 2000;321:926-7; Hawton, et al. BMJ 2001;322:1203-7), although the results are not completely consistent between studies. Information on this critical experiment is not mentioned in the briefing material posted on the FDA's website.

The following is a six-point plan to address the acetaminophen overdose problem in all its manifestations. While some primarily address intentional overdoses, many of these will also affect unintentional overdoses.

1. Consumer access to risk information
The currently required acetaminophen label is woefully inadequate, excluding even the liver-toxicity warning recommended a quarter of a century ago by the FDA's own advisers. In addition to including a general warning about liver toxicity, the label should mention the early symptoms of liver toxicity and instruct patients to discontinue the drug and seek medical attention should such symptoms appear. It should also warn against the simultaneous use of multiple acetaminophen-containing products. As many of these elements as possible should appear, in sufficiently large typeface, on the container itself, as has successfully been done with children's aspirin in the successful attempt to prevent Reye's Syndrome. If the box warning becomes unwieldy, consideration should be given to a system of rotating warnings, as has become standard on tobacco packs. A patient information leaflet in each package should also be mandated.

Other modes of communication should also be used to warn consumers. Advertising for acetaminophen-containing over-the-counter products (regulated by the Federal Trade Commission, not the FDA) should also require the warnings mentioned above. The FDA should also write articles in medical and lay journals to increase health professional and consumer awareness of the problem. Public Service Announcements are also an important part of such a strategy.

2. Reduce maximum daily doses
Among unintentional adult acetaminophen-related liver toxicity cases reported to the FDA or published in the medical literature (a total of 282 between January 1, 1998 and July 25, 2001), the median daily dose was 5 g/day (range: 0.65-30 g/day), not much above the FDA-recommended maximum of 4 g/day. Among those with a history of alcohol use, the median dose was 4.6 g/day, compared with 5.8 g/day among those without such a history. This argues strongly for a reduction in the maximum daily dose for alcohol users. Patients with liver toxicity and underlying liver disease also had consumed low daily doses of acetaminophen (median: 4 g/day) as did those taking potentially liver-toxic medications in addition to acetaminophen (median: 3.9 g/day); this argues for similar maximum daily dose restrictions in these populations. The margin of safety is even small for patients without these underlying conditions. Restrictions on daily doses should be considered for them too.


3. Reduce per-tablet doses
Because there is a strong relationship between the amount of drug consumed and the incidence of serious overdose and death, and because there is a practical limit on how many pills a suicidal patient can take, it is logical that a reduction in the strength of individual dosage forms to 325 mg per tablet would yield benefits. Such a restriction is likely to also benefit pediatric patients who ingest acetaminophen- containing products as well as those unknowingly taking multiple acetaminophen- containing products. There is precedent for such a restriction. Over-the-counter ibuprofen contains only 200 mg of the drug, compared with up to 800 mg in the prescription versions.

4. Standardize liquid formulations
Cases of liver toxicity reported to the FDA or reported in the medical literature between January 1, 1998 and July 25, 2001 included 25 pediatric cases. In at least four of these, teaspoonfuls of medication were administered, instead of dropperfuls. While acetaminophen suspension contains 32 mg/ml, the drops contain 100 mg/ml, ample opportunity for unintentional overdose. All liquid forms of the drug should be required to have the same concentration.

5. Remove irrational acetaminophen-containing combinations from the market
Forty-nine percent of over-the-counter acetaminophen sales is in the form of combination products. Most, if not all, of these combinations are irrational. Patients (and their parents) should be encouraged to use only the medication they need, not lapse into this shotgun approach to drug therapy. The use of combination products with elaborate (often misleading) brand names discourages patients from learning the generic names of active ingredients, potentially leading to overdoses when taken with other acetaminophen-containing drugs. Approximately 25% of patients with liver toxicity collected by the FDA had taken more than one acetaminophen-containing product.

6. More research
It has been suggested that all acetaminophen-containing products be combined with N-acetylcysteine, the drug used to treat acetaminophen overdose. While we are aware of no studies documenting the effectiveness of this approach, it does merit further study. The impact of any interventions to reduce acetaminophen-related liver toxicity adopted by the FDA should also be measured so that new measures can be added if appropriate.

None of these approaches will be enough on its own to eliminate acetaminophen overdoses. Only a multidimensional approach is likely to significantly reduce the enormous burden of suffering and the expenditure of scarce health care resources currently represented by this in-large-part preventable problem.
http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882oph1.htm
http://www.publiccitizen.org/publications/release.cfm?ID=7202
-Kimberly Balas
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Tylenol
Here is one article I dug up from my archive of information from Kimberly Balas.
Hope this helps. -Marguerite

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Info on using Tylenol and other things for fever - DANGER
Gary L Krasner wrote: The following article originally appeared in the Well Beings newsletter, a publication of Vaccination Alternatives, NYC,

CHICKEN POX: Why Do Children Die?
By Gary Krasner (gk-cfic@juno.com)

------------teaser-------------- While chicken pox is rarely fatal, vaccination proponents in New York State want to mandate universal vaccination of school children against varicella. But rather than keeping them away from "infected" kids, Natural Hygienists suggest a better way regain health and avoid death: Keep them away from allopathic physicians!

-------------main------------------ After learning of the legislative attempt to make the varicella vaccine mandatory in New York, I looked for a handle for an article. Since I didn't recall that chicken pox had ever been grouped in the category of medicine's infamous "Killer Diseases", I thought I should find out how the Medical Boys justified making it compulsory for school children. It became apparent that the only medical justification for this vaccine had been the claimed mortalities. I went to the CDC's website and found something revealing in the May 15, 1998/Vol. 47/No. 18 issue of Morbidity and Mortality Weekly Report (MMWR, their official publication). It was entitled, "Varicella-Related Deaths Among Children: Texas and Iowa notified CDC of three fatal cases of varicella (chickenpox) that occurred in children during 1997." A short introduction stated that in the U.S. there are approximately 100 deaths (about half of these in children) and 10,000 hospitalizations each year for complications from chicken pox from infection with the varicella virus.

After going over the report, I remembered why I stopped reading medical journals. In each of the three cases the young boys started out with fevers and/or other minor inflammatory conditions. Following each regimen of antibiotics, analgesics, or steroidal medications their condition grew progressively worse. The doctors responded to each new symptom with yet another drug, until they died. Having an understanding of Natural Hygiene (briefly described by Harvey Diamond in his best seller, Fit For Life), I understood specifically why some of the drugs caused the adverse effects. But even equipped with a rudimentary understanding of the principles of N.H., one would realize that chicken pox is not a fatal disease, but rather a very common, benign inflammatory condition. And fatalities-as rare as they are-must actually result from inappropriate care, or the kinds of aggressive medical interventions described in the MMWR report.

With paraphrasing here and there, the remainder of this page is taken from the section on chicken pox from the book, Food Is Your Best Medicine by Henry Bieler, M.D. He was a renowned clinician practicing in Pasadena, CA for over 50 years until his death in 1975. Dr. Bieler's skills were sought after by Hollywood celebrities and honored by his peers (a medical wing was named after him). Chicken pox arises from the elimination of toxic fat or fatty acids through the hair fat glands. The chemical burn from the purging of waste products though the skin causes the characteristic blister of this disease. This occurs when the liver is congested and cannot perform its eliminative function and metabolic waste matter (toxins) is then thrown into the bloodstream. These toxins in the blood must be discharged, so nature uses vicarious avenues of elimination, or "substitutes". When these bile poisons (from the liver) in the blood come out through the skin, we get skin conditions manifested by rashes, boils, acne, etc. Or they come out through the mucous membranes (inside skin) manifesting as various catarrhs, like chicken pox. Thus, the skin is "substituting" for the liver, or a vicarious elimination is occurring through the skin.

FOOD AND DRUGS ARE CONTRAINDICATED During the more acute and involved forms of toxemia, such as measles, chicken pox, fever, or flu, the liver is much too busy neutralizing toxic wastes to be bothered with digestion of food. Therefore, to facilitate the elimination of this waste, fasting on distilled water is essential in such cases. This accounts for the lack of digestive juices produced, and the loss of appetite that accompanies these illnesses.

After cells have been damaged by the toxic wastes, it is important for bacteria-acting as scavengers-to attack and devour the weakened, injured and dead cells. Otherwise, these dead cells would become accumulated toxic waste themselves. Therefore, antibiotics and other bactericides must not be administered. The so called "bad" bacterial strains die out on their own anyway, once their food (toxic waste) is used up. But until that point, they play an important role in the process that converts waste for eventual elimination.

The class of drugs that doctors use to treat catarrhs like chicken pox are called antipyretics. Among antipyretics, aspirin tops the list of favorites. Aspirin is a phenol (carbolic acid) derivative, with all the chemical qualities of phenol, but without the deadly effect of carbolic acid. Aspirin, like phenol, deadens the nerve endings, thereby masking pain. But aspirin also diminishes a fever by partially blocking the thyroid and the adrenal glands (a bad thing). The phenol derivatives interfere with the proper function of the liver and damage liver cells. The use of aspirin, then, is an attempt to drive out one devil (disease toxins) by admitting another devil!

THE IMPORTANCE OF FEVER - Fever in a child is a frightening symptom to the mother. Just what is the function of fever? Is it a harmful process, something to suppress and worry about? Or is it the body's attempt to burn up a poison, thereby helping to dispose of it more quickly?

In the diseases of childhood, fever begins in the liver. In a very strong, robust child, with properly functioning endocrine glands, the toxin is often completely consumed in the liver. The child does not feel sick or have pain; he just has a fever and if the liver area is carefully palpated, it can be noted that there is an elevation of temperature over that organ. In fact, if the temperature under the tongue is 105 degrees, the internal temperature of the liver may be as high as 110 degrees. But if the liver is unable to oxidize completely the poisons of disease so that some leak through into the blood stream, then, under the action of the endocrine glands, the poisons seek vicarious outlets via the mucous membranes. This may be through the upper respiratory tract, in the form of flu, sinusitis, pharyngitis, tonsillitis and possibly even pneumonia, which is a complicated kind of bronchitis. All through this process, the whole power of the liver is diverted into neutralizing the toxic wastes of disease, as evidenced by the fever.

The liver is much too busy to be bothered with the task of the digestion of food. Great strain can be taken off that organ if no food is given. Not only does fasting lower the temperature, relieve the distress and facilitate elimination, but it also lessens the strain on the liver and prevents serious complications, such as middle-ear disease, mastoiditis and meningitis. Left alone, a fever will not exceed 106 degrees. And only about 4 percent of children experience fever-related convulsions, with no serious aftereffects.

A fast (on distilled water, or at least diluted fruit or vegetable juices) should be continued for twenty-four hours after the temperature has returned to normal. A good rule to remember is that the bowel can be cleared of toxins (by physic or enemas) in twenty-four hours; the blood in three days; the liver in five days, providing no food is eaten. Shingles ("adult chicken pox"), an eliminative crisis through the mucous membranes that occurs in adults, may require about a week-long fast to completely clear up.

It appears then, that fever, dreaded because misunderstood, is really nature's attempt to help. It is discomforting, but never does harm; never is attended with serious aftereffects and never should be suppressed with anti-inflammatory drugs or fed with food. I have seen many a case of flu pushed into a pneumonia because some anxious grandmother insisted upon something "to give the child strength", such as chicken broth or a thin starchy gruel, both liquids, of course, but protein and starch-just what the liver cannot handle at this point.

THE TRUE CAUSE OF "INFECTIOUS" DISEASE From Dr. Bieler's words we gain a little understanding of Natural Hygiene. So called "infectious" diseases like chicken pox, measles, or whooping cough are actually inflammatory diseases. The symptoms during such illnesses should be viewed as eliminative crises. They may be very painful, but they're a necessary self-limiting process in which an accumulation of retained metabolic waste (dead cells that become toxic), and the residues of undigested, unassimilated foods are being purged from the body through vicarious (abnormal, inappropriate) channels such as the skin or lungs. So the familiar runny nose, cough, stiffness, fever, and numerous rashes, swellings, lesions, and eruptions through the skin are all manifestations of the same cause-which are not pathogenic microbes.

Microbes like bacteria, for example, act as scavengers to consume the toxic wastes and the dead cells following inflammation. Their formation and growth do not precede the diseased state in the host, but rather emerge in its wake; and not exogenically-from say, an "infected" person-but rather endogenically, from the genetic material contained in a cell's nucleus after the cell's death and decomposition. Fortunately, a wide range of bacterial strains, or their genetic "blueprints" (e.g., the various cellular and sub cellular-or "filterable"-stages that bacteria cycle through), inhabit our bodies all the time in titers low enough that their waste products do not affect us. Recently reported villains like salmonella, e. coli, or streptococcus are enteric and ever-present inside us. The viruses associated with measles, polio, influenza, and all the rest are also present-both in health and disease-and may have only an associative relationship with the diseases, but no proven causative roles. (Incredibly, modern medicine still hasn't determined the mechanism by which a virus causes poliomyelitis.) But when we become toxemic and our blood loses its alkalinity, the pathogenic strains begin to flourish in the bodily waste that accumulates-even well before any outward symptoms (inflammation and elimination) begin to appear. Their morphology (strain and function) is determined by the type of waste that is present for them to feed upon.

Symptoms are often triggered by a physiochemical or psychological "trauma", such as exposure to cold or toxic chemicals, stress, lack of sleep, ingestion of spoiled meat, a sting or bite from an insect, or an injected vaccine. Why these diseases occur predominantly in children is best described by Dr. Bieler: "The childhood years should be the healthiest of all. It is during those early years that the endocrine glands and the liver are in their best functional capacity, giving the healthy child his natural state of exuberance, inexhaustible energy, and faultless elimination". When elimination ends and symptoms subside, doctors will proclaim that the drug had "taken effect". But they are confusing symptoms with cause; believing that the disappearance of the former equates to the disappearance of the latter. But obviously a cause and an effect cannot be one in the same. When you stop the body from discharging toxic waste, you are not stopping the disease; you are merely stopping the effects.

But more importantly, when Allopathic physicians employ pain killers, fever suppressants, steroids and other drugs-which are sub-lethal doses of poisons-they have the effect of weakening the patient to the extent of checking elimination. This is a dangerous effect, because the waste products of these germs that have fed on the dead cells, together with the irritation from the toxins themselves may be absorbed into the blood, and irritating the already overworked liver-which is the detoxification center of the body. Antibiotics-which literally means "against life"-act chiefly by violently stimulating the adrenal glands. But if they are weak or depleted, the disease runs a chronic, often recurring course. In the aftermath of these germicides, there are also left fewer germs to convert waste, and no means to carry off and eliminate the dead cells. Not surprisingly, there are more deaths today from septicemia (blood poisoning caused by toxic waste from putrefactive bacteria) than there were before the use of antibiotics. (One of the boys from the MMWR report died from it.) Reactions from antibiotics include anaphylactic shock, aplastic anemia, and induced virulent infections. Death from penicillin still occurs.

CHICKEN POX DOESN'T KILL; DOCTORS KILL It's now plain to see why the children described in the afore-referenced MMWR had died. They were given numerous antibiotics, steroids, antipyretic and antipruritic medications and other fever suppressers, some administered directly into their blood streams. Probably they were given food to eat as well, even during the height of their inflammatory responses. The CDC admits that children don't die from chicken pox per se, but rather "complications" from chicken pox. But what they don't say is that these complications are all derived from acute blood toxemia established by the very treatments used by allopathic physicians.

What does the CDC list as the most common complication? Pneumonia and secondary bacterial infections (caused by the antibiotics). Other complications, according to the CDC, include encephalitis (inflamed brain tissue mostly from the antipyretics), hemorrhagic complications (such as intestinal bleeding, are the most common symptoms of aspirin-an anticoagulant, or "blood thinner"), hepatitis (congested and inflamed liver caused by the antipyretics), arthritis (decalcification of bone for the calcium needed to neutralize acidic blood, mostly caused by the aspirin), and Reye's syndrome (most commonly associated with giving aspirin to children that have chicken pox or influenza). Prescribing acetaminophen (Tylenol, etc.) in large doses is also toxic to the liver and kidneys, because they also check the vital actions of the body to discharge waste from the blood.

Therefore, to say that "death is a complication of chicken pox", is like saying, "bleeding is a complication of holding a knife in your hand": each event is neither contingent nor a consequence of the preceding one. Their association is artificial; requiring specific actions to take place. Actions that are in accord and mandated by standard medical practice.

To promote the vaccine, the CDC proclaims that, "varicella (chicken pox) is the leading cause of vaccine-preventable deaths in children in the United States." But while the deaths are certainly preventable, they have nothing to do with the vaccine.
Copyright 1999 by Gary Krasner

Two Books available from Foundation for Advancement in Cancer Therapies, Box 1242 Old Chesea Sta., New York, NY 10113. Make checks payable to FACT, Ltd. Add $2 S&H. Add $3 for first-class postage. Foreign orders: use postal money orders.

1---Food Is Your Best Medicine by Henry G. Bieler, M.D. Paperback, 1982 by Ballantine Books (236 pages). - $5.99

2---Toxemia Explained by Dr. John Tilden. ©1976 by Keats Publ., New Caanan, CT. (130 pages). The theories of the successful clinician, John Tilden (1851-1940), who practiced conventional medicine for 18 years, then abandoned the use of all drugs to run a school and sanitarium in Denver. Describes toxemia as the basis of all diseases.- $5.50 -Kimberly Balas
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This stuff is abused in the long term care facilities. I know elderly people who take this stuff around the clock every single day every 4 - 6 hours. I just do not see how there liver can take it. No wonder so many elderly people die in nursing homes. They take Tylenol and protonix like candy. It is a vicious cycle. You just wouldn't believe it. I have taken it, but only as a last resort. However, I am scared to take it no more one dose. I would never take it like I see it prescribed to the elderly or like some people do. -Darcy
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I found a website that gave me everything I needed www.tylenoldanger.com
-Kasara D'Elene
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