Consumers Against High Drug Prices
Exposing The FDA's Regulatory Quagmire
CoQ10 Wars
Assembly Line Medicine
Collapsing Within Itself
Intolerable Delays!
"Unsustainable" Cancer Drug Prices
How Government Treated Those For Whom We Now Celebrate Holidays
Horrific Conditions Inside Drug Factories
When "Rules" Are Broken
Federal Death Panels
Science by Ambush
The Looming Doctor Shortage
Former FDA Commissioner Admits Risk of Bureaucratic Delay
FDA Says Walnuts Are Illegal Drugs
The FDA's Most Heinous Drug Approval
No Real Healthcare Cost Crisis
FDA Delay of One Drug Causes 82,000 Lost Life-Years
Deadly FDA Neglect
How Much More FDA Abuse Can Americans Tolerate?
Drug Company Pleads Guilty to Health Fraud
Why American Healthcare is Headed for Collapse
The Generic Drug Rip-off
Ending the Atrocities
Millions of Needless Deaths
Would You Tolerate This Abuse?
The FDA Indicts Itself
The FDA's Cruel Hoax
Fish Oil Now Available by Prescription!
FDA Threatens to Raid Cherry Orchards
Inside the FDA's Brain
FDA Fails to Protect Domestic Drug Supply
FDA Permits New Fish Oil Health Claim
FDA Approves Deadly Drugs, Delays Lifesaving Therapies
The $50.00 Toll Bridge
Dangerous Medicine
Cardiologists Overlook Lifesaving Discovery
What You Don’t Know About Blood Sugar
Jerry Falwell Attacks Life Extension Foundation
Life Extension Achieves "Impossible" Victory in the U.S. House of Representatives
Fighting the FDA
Patient Advocates Sue FDA Over Drug Access
FDA's Lethal Impediment
Don't Blame the Doctors
One Man's Ten-Year Ordeal With Prostate Cancer
A New Day At FDA?
The FDA Versus the American Consumer
Supreme Court Roundup
The Lethal Information Gap
Consumer Rape
Dying From Deficiency
Are Offshore Drugs Dangerous?
Drugs the FDA Says You Can't Have
Does Cholesterol Cause Artery Disease?
What's Wrong with the FDA
FDA Suffers Second Massive Legal Defeat in Pearson v. Shalala
FDA Loses Case Against Compounding Pharmacies on First Amendment Grounds
Ending The Cancer Bureaucracy
Victory in the House and Senate
Life Extension Wins in the House and Senate
Congress Recognizes The Prescription Drug Problem
Americans are getting Healthier... But the FDA Remains a Major Impediment
Are We to Become Serfs of the Drug Monopoly?
A Glorious Victory Over FDA Tyranny
The Great American Rip-Off
The Plague Of FDA Regulation
Health Costs to Double Is there a free-market solution?
The FDA versus Folic Acid
They Want You Brain Dead
Life Extension vs. the FDA a Hollow Victory: Why the Agency's Approval of Ribavirin is Inadequate
FDA Approves Deadly Drugs, Delays Lifesaving Therapies
William Faloon

What if a dietary supplement was shown to kill 100 Americans and cause 56,000 emergency room visits each year?1 Without a doubt, the supplement would be banned immediately and those who knowingly marketed such a lethal product would be subject to severe criminal penalties.

On January 22, 2004, the FDA confirmed what Life Extension members have long known that acetaminophen is extremely dangerous.2 Acetaminophen is sold under the brand name Tylenol® and is contained in 600 other drug products. Life Extension revealed the toxicity of acetaminophen more than 12 years ago. We harshly criticized the FDA for not mandating that the label of acetaminophen products warn those with liver or kidney problems to avoid the drug.

In 2002, an FDA scientific advisory committee urged that warnings be put on the labels of acetaminophen drugs.3,4 Despite overwhelming documentation confirming acetaminophen's toxicity,5-28 the FDA said no to its own scientific advisors. Instead, the agency has budgeted a mere $20,00029,30 to develop material that it hopes will be run in major magazines and distributed by pharmacy chains for free! This is the bureaucratic equivalent of doing nothing.

We at Life Extension are incensed about the FDA's multi-decade failure to mandate warnings on deadly acetaminophen products. The agency spends tens of millions of dollars a year attacking companies selling natural health products that have harmed no one. Yet the FDA is making virtually no effort to prevent the 100 deaths and 56,000 emergency room visits that the agency itself admits are caused by acetaminophen drugs every year!31

Acetaminophen Risks UnderstatedBack in 1992, we warned that many more people are dying because of acetaminophen than the number indicated by the official statistics. While the FDA was pre-occupied with acetaminophen-induced liver failure, it overlooked studies showing that regular users of acetaminophen may be doubling their risk of kidney cancer.11,13,32

What does that translate to in actual numbers of victims? Each year, almost 12,000 Americans die of kidney cancer.33 The incidence of kidney cancer in the US has risen 126% since the 1950s,34 a jump that may be tied to the growing use of drugs containing phenacetin or acetaminophen.

Phenacetin is a painkiller that was banned because it causes severe kidney toxicity.35-40 Acetaminophen is the major metabolite of phenacetin, which means that some of the destructive properties exhibited by phenacetin could have been caused by its breakdown to acetaminophen in the body. So while phenacetin was withdrawn because too many people's kidneys were shutting down, the FDA had no problem letting the major metabolite of phenacetin (acetaminophen) be freely marketed without any consumer warning whatsoever.

If acetaminophen is responsible for even a small percentage of the overall kidney cancer cases, this drug may have already killed tens of thousands of Americans and the FDA has done nothing to stop this carnage!

Because acetaminophen generates damaging free radicals throughout the body, it may very well increase the risk of many age-related diseases. In fact, scientists can consistently induce cataracts in the eyes of laboratory animals by giving them acetaminophen. They consider acetaminophen a "cataratogenic agent."¯ Interestingly, if antioxidants are provided to the animals, the cataract-inducing effects of acetaminophen are often completely neutralized.41-46

One of Life Extension's medical advisors long ago advocated that acetaminophen products include the antioxidant N-acetylcysteine to help neutralize destructive free radicals. When a person acutely overdoses on acetaminophen, the standard medical therapy is to administer N-acetylcysteine over a period of weeks. Unfortunately, the FDA bans the combination of an over-the-counter drug (acetaminophen) with a dietary supplement (N-acetylcysteine), so it is "illegal"¯ to make a safe acetaminophen drug.

To alert as many people as possible to the risks of acetaminophen poisoning and its antidotes, we have included a chapter on this topic in all four editions of our Disease Prevention and Treatment book. Despite the overwhelming evidence that acetaminophen use should be strictly limited, the FDA capitulates to pharmaceutical companies that earn billions of dollars a year selling this lethal class of analgesic drug.

By failing to mandate a warning on the label of acetaminophen products, the FDA once again demonstrates its propensity for protecting the pharmaceutical industry's economic interests at the expense of the American public's health.

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