FDA Neglect on acetaminophen poisoning

"Each year, acetaminophen poisoning results in 100,000 calls to poison centers, 56,000 emergency room visits, 26,000 hospitalizations and more than 450 deaths from liver failure."

Below is an exerpt from Life Extension Magazine, original article link is HERE

You might be surprised to know that the leading cause of acute liver failure in the United States is not alcohol abuse, nor viral hepatitis.

The number one reason Americans suffer acute liver failure is a drug the FDA has allowed to be sold for decades after its lethal toxicities were known.1

This drug is available over-the-counter and in prescription combinations. In many cases, those ingesting this toxic drug (under various brand names) don’t even know they are taking it.

The FDA has bent over backwards to protect billions of dollars of profits earned annually by pharmaceutical companies who sell this deadly drug.

As the body count mounted in 2009, the FDA was forced to mandate a lower dosage and remove it from prescription combinations that were particularly lethal.2

The FDA’s feeble actions to appease critics are too little and far too late. The reduced dose will spare some lives, but this toxic drug will still inflict a considerable death toll. The fact that this carnage has gone on for decades confirms the FDA’s blatant failure to protect the public.

What Called My Attention to This Drug-Induced Bloodbath?

Back in the early 1980s, I was having one of my all-night brain-storming sessions with scientists who routinely think “outside the box” when it comes to medical issues. One of these scientists enlightened me to the mechanism by which the pain reliever acetaminophen causes liver damage.

When acetaminophen is ingested, a rapid depletion of glutathione in the liver occurs.3,4 The result of glutathione depletion is free radical destruction of liver cells.5-9 The scientists I spoke with suggested that Life Extension® make a combination product of acetaminophen and N-acetyl cysteine (a glutathione-enhancing amino acid). According to these scientists, this would probably eliminate virtually all acetaminophen-related acute deaths.10-14

Since acetaminophen and N-acetyl cysteine are both sold over-the-counter, you might think that making a “safer” acetaminophen formula would not be difficult.

There is one problem. The FDA prohibits combining existing drugs and dietary supplements unless a New Drug Application is filed, tens of millions of dollars of clinical studies are performed, and the FDA agrees to allow the combination to be sold. The whole process can cost upwards of $100 million and take a decade to complete.

So by bureaucratic edict, a safer form of acetaminophen never made it to market.