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FDA Approves Deadly Drugs, Delays Lifesaving Therapies

May 2004

By William Faloon

LE Magazine May 2004

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 Understated
Back 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.