Johnson & Johnson, Procter & Gamble and other manufacturers are arguing that cough and cold drugs with the pain reliever acetaminophen should stay on the market, in spite of concerns from U.S. regulators.
The FDA is weighing a ban on combination products, which are often marketed to consumers with colds or other mild illnesses. The industry instead urged a widespread effort to warn buyers about the risks of liver damage linked to acetaminophen.
Too much acetaminophen has been known to cause liver injury for decades, but FDA officials are worried that the rise of products that combine it with other medications will lead consumers unknowingly to overdose by taking too much of a medication, or by taking too many different products at once.
The FDA advisory panel that met about the effects of excessive doses of acetaminophen also made another recommendation to the FDA-- to take popular painkillers Vicodin and Percocet (and their generic versions) off the market because of the effect both drugs can have on the liver when taken for extended periods.
The FDA will most likely follow this recommendation.Vicodin is a combination of hydrocodone and acetaminophen; Percocet is oxycodone and acetaminophen. While oxycodone is available without the acetaminophen (as OxyContin) hydrocodone is not available alone in the United States.
|Dr. Mercola's Comments:|
Most people do not think twice about popping a couple of Tylenol (acetaminophen) here and there if they have a headache or some other ache or pain. In fact, up to 100 million Americans take acetaminophen every year.
But you should know that acetaminophen use is actually the leading cause of acute liver failure in the United States.
Many people skim when they read so let me repeat this is amazing fact. The NUMBER ONE cause of acute liver failure in the United States is from taking Tylenol type products.
Now an FDA advisory panel is finally recommending that cough and cold drugs that contain the pain reliever acetaminophen be banned altogether because of these serious risks of liver damage. The panel also recommended taking the popular prescription painkillers Vicodin and Percocet (which both contain acetaminophen) off the market because of similar risks of liver damage.
This is no small issue considering acetaminophen is found in more than 200 over-the-counter cold and flu remedies and other medications, making it the most widely used painkiller in the United States.
The drug companies, including Johnson & Johnson, Procter & Gamble and other manufacturers, stand to lose a lot of profits if the ban does go through; acetaminophen-containing products brought in $2.6 billion in 2008.
So of course the drug makers are completely against the ban and say the acetaminophen-containing products should stay on the market despite regulators’ concerns.
Serious Health Risks Can Occur Even at Recommended Doses
It’s widely known that overdosing on acetaminophen can cause liver damage, and the current concerns are stemming largely from the rise of OTC products that combine acetaminophen with other drugs. The FDA officials believe this may lead consumers to unknowingly take multiple products that contain acetaminophen and result in overdoses.
While this is certainly a valid concern, even more striking is the Journal of the American Medical Association study that found Tylenol can harm your liver even at regular, recommended doses.
The study involved 106 participants, some of whom took four grams of Tylenol (or eight extra-strength Tylenol tablets) every day for two weeks. Up to 40 percent of the people taking Tylenol had abnormal test results that signaled liver damage.
A separate study in the American Journal of Respiratory and Critical Care Medicine also found that regular use of acetaminophen was harmful. They linked it to higher rates of asthma and chronic obstructive pulmonary disease (COPD), as well as reduced lung function.
Long-term Tylenol use has also been linked to kidney failure, and about 15 percent of the people on dialysis today are there as a result of the damage that Tylenol (and/or aspirin) did to their kidneys.
What Makes Acetaminophen so Toxic?
Most experts believe Tylenol causes its damage by depleting glutathione, an antioxidant that protects cells from toxins such as free radicals.
So while I do not recommend using acetaminophen, if you do take Tylenol or other types of acetaminophen regularly you can limit some of the damage by taking N-acetyl cysteine (NAC), which is the rate-limiting nutrient for the formation of the intracellular antioxidant glutathione.
If you keep your glutathione levels up, the damage from the Tylenol may be largely preventable. Even conventional medicine recognizes this, as anyone who overdoses on Tylenol receives large doses of NAC in the emergency room.
FDA Making Mistake
While I deeply appreciate the aggressive actions on acetaminophen, I am not convinced that removing it from the most common form of prescription pain killers is a wise move.
Obviously I am not a fan of using drugs but I am also highly appreciative of the advances in modern pharmacology that allow us to effectively suppress pain while we are seeking to address the underlying cause of the problem.
Frequently the cause of the pain problem is an acute injury or trauma and the only solution is time and rest.
To me it seems the far wiser move by the FDA would be to mandate the use of NAC to be included with all the prescription acetaminophen products, which would virtually eliminate their toxicity.
Not sure how the FDA can be so blind to the obvious, especially when they have already given NAC an indication for the treatment of acetaminophen overdose.
Why Are You REALLY Taking Acetaminophen?
If you suffer from one of the conditions commonly treated with acetaminophen, such as headaches, joint pain and fevers, be aware that there are almost always reasons behind your symptoms. Acetaminophen only provides symptomatic relief and in no way, shape or form treats the underlying cause of the pain.
Remember, your pain typically serves a very useful purpose, signaling that something is not right -- prompting you to resolve your problem at its root level.
Unfortunately, most are brainwashed and resort to a drug model to cover the problem up.
So instead of taking a taking an OTC painkiller, seek to address what’s really causing your pain.
Natural Alternatives for Pain Relief
As you work to uncover the source of your pain, whether it is due to injury, stress or other illness, you don’t need to suffer unnecessarily. The following options provide excellent pain relief without any of the health hazards that typical pain relievers, even OTC varieties, carry:
- Meridian Tapping Technique (MTT), which is currently being used by more than 15,000 psychologists, is a drug-free approach for pain management of all kinds. MTT borrows from the principles of acupuncture, in that it helps you balance out your subtle energy system.
It helps resolve underlying, often subconscious, negative emotions that may be exacerbating your physical pain. By stimulating (tapping) well-established acupuncture points with your fingertips, you re-balance your energy system, which tends to dissipate pain.
- Ginger: This herb is anti-inflammatory and offers pain relief and stomach-settling properties. Fresh ginger works well steeped in boiling water as a tea or grated into vegetable juice.
- Boswellia: Also known as boswellin or "Indian frankincense," this herb contains specific active anti-inflammatory ingredients. This is one of my personal favorites as I have seen it work well with many rheumatoid arthritis patients.
- Krill Oil: The omega-3 fats EPA and DHA contained in krill oil have been found, by many animal and clinical studies, to have anti-inflammatory properties.
- Bromelain: This enzyme found in pineapples, is a natural anti-inflammatory. It can be taken in supplement form but eating fresh pineapple may also be helpful.
- Cetyl Myristoleate (CMO): This oil, found in fish and dairy butter, acts as a "joint lubricant" and an anti-inflammatory. I have used this for myself to relieve ganglion cysts and a mild annoying carpal tunnel syndrome that pops up when I type too much on non-ergonomic keyboards. I used a topical preparation for this.
- Evening Primrose, Black Currant and Borage Oils: These contain the essential fatty acid gamma linolenic acid (GLA), which is useful for treating arthritic pain. I personally prefer the use of GLA supplements from evening primrose oil but borage oil contains a higher concentration of GLA, which means you need fewer capsules, and it tends to be less expensive.
- Cayenne Cream: Also called capsaicin cream, this spice comes from dried hot peppers. It alleviates pain by depleting the body's supply of substance P, a chemical component of nerve cells that transmits pain signals to your brain.
- Methods such as yoga, acupuncture, and even holding hands can also result in astonishing pain relief without any drugs.
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