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The Dangers of Tylenol: Is it Time for the FDA to Remove it From the Market?

The Dangers of Tylenol: Is it Time to for the FDA to Remove it From the Market?

photo from Wikicommons

Most people consider acetaminophen (e.g., Tylenol) as being an extremely safe pain reliever for both children and adults. The reality is that it can be extremely dangerous and causes significant side effects. Each year acetaminophen causes over 100,000 calls to poison control centers; 50,000 emergency room visits, 26,000 hospitalizations, and more than 450 deaths from liver failure. In addition, regular use of acetaminophen is linked to a higher likelihood of asthma, infertility, and hearing loss (especially in men under 50 years of age).

The FDA has done a poor job alerting the public to the dangers of acetaminophen. In my opinion, it is a drug that serves no real medical purpose in the 21st century. Its use should be curtailed or even eliminated entirely.

Background Data
Acetaminophen is the only remaining member of the class of drugs known as "aniline analgesics" that is still on the market. The rest were discontinued long ago. Acetaminophen only blocks the feelings of pain and reduces fever, it exerts no significant anti-inflammatory action.

Acetaminophen is very hard on the liver and is known to reduce the liver's store of the important detoxifying aid and antioxidant glutathione. When acetaminophen is combined with alcoholic drinks or other compounds toxic to the liver including other medications, its negative effects on the liver are multiplied. It should definitely not be used in anyone with impaired liver function.

Acetaminophen is often the drug of choice in children to relieve fever. However, use for fever in the first year of life is associated with an increase in the incidence of asthma and other allergic symptoms later in childhood. Asthma appears to be another disease process that is influenced greatly by antioxidant mechanisms. Acetaminophen severely depletes glutathione levels not only in the liver, but presumably other tissues as well and should definitely not be used in people with asthma.

New Data
On August 1, 2013 the FDA released a notification on acetaminophen that it is now associated with rare, but severe and sometimes fatal skin reactions even at recommended dosages.

These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) are associated with reddening of the skin, rash, blisters, and detachment of the upper surface of the skin. These reactions can occur at any time while acetaminophen is being taken – they can happen the first time it is used or after long-term use. Other drugs used to treat fever and pain/body aches (e.g., non-steroidal anti-inflammatory drugs, or NSAIDS, such as aspirin, ibuprofen and naproxen) also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels.

The FDA's solution is that they will now require that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions. FDA will also request that manufacturers of OTC acetaminophen drug products to add a warning about serious skin reactions to the product labels.

It just might be time to pull the plug on acetaminophen. Can you imagine if the side effects and risks associated with acetaminophen were associated with a dietary supplement? It would be yanked from the market immediately. The FDA needs to quit following a double standard and instead look after the public's best interest not only by calling for more warnings on labels, but also by pulling from the market outdated, potentially dangerous drugs especially those available over-the-counter.


Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of GreenMedInfo or its staff.

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Acetomenophine, NSAIDS--Naproxin, et al.

I emigrated to Canada 40 years ago, and I'm told who my "doctor" will be.  I've had unbelievably disastrous "care".  In January 2001 I suffered a subarachnoid brain hemorrhage, home alone at night.  I was a Realtime Broadcast Captioner for the hearing impaired, and I had a nightly show that gave us all the shivers.  We only had sound over the telephone wires, and no visuals on TV; that came later in the night as the show moved westward.  I probably wasn't alone in making special preparations for that show, by a guy named Mike Bullard, who had been a working-class character with a caustic, cringe-worthy, abusive sense of untrained, unfettered humour.  I wrote him five nights a week.  He came after my all-time favourite Toronto news show.  I'd have 45 minutes to lie in a tub of warm water breathing zen-style, trying to coax down my blood pressure and fear.

That night I had a world-class menopausal hot flash in the tub.  It was a bitterly cold January night.  I jumped out of the tub and ran to open the little window and stick my head outside.  It didn't help, as it had in the past.  Then I spent 45 minutes flailing on the bathroom floor, screaming at myself to breathe.  There was an infinite being sitting calmly on my counter.  I thought it was God, and I was heart broken to see God was not offering me help.  I had thought that my many years of art work-- I'd done ten years of university as a fine arts major-- had been guided by God, whom I had obeyed without question from Day One.  I knew I was very close to death, and I realized that God wasn't fussy about my art after all and was going to let me die into a crumpled CocaCola can on my bathroom floor.

I realized I was on my own, without any divine help, and I said to myself okay, I'll try to save myself, by myself.

I knew oxygen was the priority, and I screamed at myself to breathe.  I'd read that Scorpios don't die easily; they fight for life to the last breath.  I was supposed to be on the air within a few minutes, and I was grateful that I was still breathing.  I crawled to my office and phoned the station and told them I was desperately ill and that they had to call my employer to get another captioner.  They were oblivious:  telling me to just do my best.

I phoned my son in Toronto; he was in school there and so was his then-girlfriend, now his wife.  They have a one-year old baby now, and they came flying up to Peterborough, where I lived.  They took me to the local hospital, and the emergency doctor in charge of the E.R. told me it was in my imagination, and to go home, take a couple Tylenol, and I'd be fine in the morning.

He refused to do any scans or tests.  That decrepit hospital was on a spree to build a new hospital, and they had been ordered to refuse to do expensive diagnostics.  I was ultimately helicoptered to a trauma centre in Toronto, where I fought for my life with actual help.  I was at Sunnybrook for four months: A renown neurosurgeon-- thank you, God-- did an 11-hour life-saving surgery.  He called me his miracle patient, and I called him my miracle doctor.

By the fourth month I was returning to being my alive, alert self in the regular scheme of things.  I was back on the air the night after I got home.  Then I had the best, most exhilerating seven years of my career.  Dr. Rajiv Midha, bless him, told me he didn't think I would have further problems.  Then he moved to Calgary Foothills Hospital to head a research project, and I would never see my miracle doctor again.

I used to caption the Peterborough news, and I saw when I got home that I was not the only one to suffer or needlessly die.  There had been many others who were denied diasgnostics, and they had died.  That hospital, of course, denied that.

Then, in my eighth year of ecstasy, it all fell apart.  Excruciating pain in my head.  Back to the now-new hospital, they laughingly told me it was fluid from the scar tissue, but it would get better, don't worry.  They were oddly correct, but I was heartbreakingly becoming too stupid to caption anymore.  I had gone to five different American universities for ten years as an fine arts major, and then four years of court reporting school in Canada.  I was a long-time member of Mensa Canada, in the top 1% of I.Q.s.  A single mother of two sons, I had worked HARD my whole life to achieve a six-figure income, and now I was too stupid, too slow, to caption.  My infrastructure was slipping away.

I had to face the inevitable.  I had been living for 13 years in paradise on a lake north of Peterborough.  I had a half acre of God's beautiful forest.  The loons would arrive at 11:55 p.m. just off my yard, and I'd leave my office door open in the warm months and caption to their haunting calls and occasional kerfuffles.  I had worked so hard to achieve my dream, and I began to lose my skills.

My son and daughter-in-law wanted me to be closer to them--getting me to the useless Peterborough hospital(s) was a two-hour drive, and I had to accept that I had become unemployable anyway.

I took my house keys down to the bank, and declared bankruptcy.  My daughter-in-law bought a little house near them in Newmarket, and my rent is cheap.  She did that so that I could keep my prescious family of cats and dogs.  My mental abilities are too scarce now to make my own decisions, so Marie is my defacto brain survival caregiver.

I haven't worked for three years.  There's nothing I can do.  I keep all my equipment set up to work, but it's a fading dream.  I captioned in my brain for the first couple years, but I'm letting it slip away now; I'll never get it back.

But my devastated spirit turns out to still be alive deep down, and I'm planning to become a tattoo artist.  There's a nice shop only blocks away, and the guy says he'll look at my portfolio.  I have a massive old one, and I'm working on acquiring new art supplies and I've bought a little library of tattoo magazines.  I'm hoping that my original gifts as an artist will prevail.  Plus, I always worked and I need a job, finally.

I started this as a commentary on the deadly acetaminophen, naproxin, statins and the whole pack of other killer drugs.

In Canada we are assigned doctors, and they are a sorry lot, in my experience.  My "new" doctor in Keswick, Ontario, is an FDA and BigPharma shill.  I saw immediately that I was on my own.  Thus, 

The "real" doctor put me on 8,000 mg daily of acetaminophen, when I weighed 84 pounds.  He denies now that he ever did that, and my current prescription is for 4,000 mg.  I take maybe 1,000.  Statins were a must.  I took them for a total of maybe a month, and two years later my bowels are still trying to barely survive.  He prescribed naproxin.  I had discovered GMI by then, and I only took three or four of those toxic nightmares.   Thank you, GMI, I take turmeric and circuma.  I take Vitamin B3 and Mercola's tiny contribution, Omega-3 Super krill.  I have deleted him from my studies, but the krill is good, I think.

I eat ginger while holding my nose. 

There is a potentially happy outcome.  After three years of trying to find a "good doctor", my trusted, beloved pharmacist gave me the name of a genuine new doctor in town.  We have an appointment next week.  I had elsewhere, through a "seniors' do-good agency" met another new doctor.  Without even touching me, she wrote the word "Aricept" on my notes.  As a court reporter I did a lot of American medical malpractice examinations for discovery, using a Canadian expert witness, and that will be with me to my dying day.  I learned that Pfeizer is pure evil, and that the golden-tongued medical counsel make their own millions defending mostly pediatric surgeons who do things like amputating a girl's conus medularus.  She had a tethered cord and spina bifida and had asked only for a little bit more mobility, thank you so much.  For the rest of her likely short life, she will be incontinent and immobile.

Not a single discovery I wrote went to trial.  It's the American way.  Children's distraught parents have lost their jobs because their insurance company had cut them off.  They had sold every little thing they could and were living, with their very sick child, in a relative's garage.  When the golden split tongues make them a disgraceful offer to settle, they have no choice but to accept it.

When my latest candidate to be my doctor wrote "Aricept/Pfeizer" in my little notebook, I came home and re-read once again the triumphs of Pfeizer, and read about the legions of victims of alzheimer's who quit using Aricept-- thank you, GMI-- I left the young doctor's secretary with the message, "No, thanks.  I would take death over Aricept."

I think I'm over by 60-words limit.

Not to worry, GMI.  You are saving so many of our lives.











Simpler solution: NAC or l-Cysteine

People admitted to hospital for acetaminophen poisoning are treated successfully with l-cysteine or NAC. Wouldn't it be simpler to approach the manufacturers and have them add a prophylactic dose to each tablet, etc? Win/win.

I noticed the lack of mention that Acetaminophen works on the endogenous anandamide pathway for pain relief. Any comment on why you'd leave out the research that shows it works by disabling FAAH thus leaving more endogenous cannabinoid in circulation? This research was borne of the decade long run in studies trying to find the secret formula to pain relief to patent from the marijuana plant.  

I humbly postulate that acetaminophen should therefore synergistically increase the pain efficacy of medical marijuana. Thus any time someone calls for banning something as ubiquitous as Tylenol on trumped up charges of an easily preventable side effect, I have my doubts as to their motivations. 



Your commentary is greatly appreciated and ads quite a lot to the discussion. 

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