Acetaminophen Overdose Is Causing 500 Deaths And
10,000 Hospitalizations Annually Due to Liver Injuries
Acetaminophen overdose causes nearly 500 deaths annually in the United States alone, as well as 100,000 calls to American. Poison Control Centers, 50,000 emergency room visits, and 10,000 hospitalizations per year due to liver damage, according to a 2017 study.
Acetaminophen (APAP), including the brand name Tylenol®,
is one of the most widely used drugs in the nation with tens of millions of consumers. Worldwide, it is the most commonly used drug for the treatment of mild to moderate pain and fever. Doctors often prefer APAP as an initial treatment for a host of pain-causing ailments, including arthritis.
The study cautioned APAP as Tylenol® is also a dose-related toxin that:
- accounts for 46% of all acute liver failure in the U.S.
- accounts for between 40% to 70% of all cases in the United Kingdom and Europe
- accounts for several-fold more deaths related to acute liver failure than all prescription drugs combined
- has been the subject of two US Food and Drug Administration (FDA) Advisory Committee meetings in the past 15 years.
The study author, William M. Lee, M.D., Digestive and Liver Diseases Division, UT Southwestern Medical Center, Dallas, TX wrote: "As an over-the-counter and prescription product (with opioids), APAP toxicity dwarfs all other prescription drugs as a cause of acute liver failure in the US and Europe, but it is not regulated in any significant way."
Dr. Lee proposed two solutions to a 50-year-old problem by suggesting that
- development of a totally safe congener of acetaminophen that would provide effective analgesia with no risk of toxicity, or
- find a new analgesic that had the same properties as APAP but without the toxicity.
The study, "Acetaminophen (APAP) hepatotoxicity—Isn’t it time for APAP to go away?" was published July, 2017 in the journal Hepatology.
Exact acetaminophen overdose statistics are difficult to ascertain
Because of the way statistics are accumulated and voluntarily reported to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and are collected during independent studies using U.S. Poison Control Center, emergency room, hospital, physicians, and patients reports, it is difficult to ascertain exact acetaminophen overdose numbers.
For example, accidental acetaminophen overdose was implicated in 1500 deaths in the past decade (150 deaths a year), still more than any other over-the-counter pain reliever, according to ProPublica.org, Sept. 20, 2013, citing data from the U.S. Centers for Disease Control and Prevention and the American Association of Poison Control Centers.
Those sources reported acetaminophen overdose sends as many as 78,000 Americans to the emergency room and results in 33,000 hospitalizations a year. It is also the nation’s leading cause of acute liver failure, according to data from an ongoing study funded by the National Institutes for Health.
It concluded that, in addition to fatalities, there was an alarming rise in reports of serious adverse drug events (ADEs) associated with acetaminophen.
Acetaminophen overdose fears lower daily dose from 4000 mg to 3000 mg
In 2011 and 2012 McNeil Laboratories, the manufacturer of Tylenol, lowered maximum dosing instructions on various Tylenol single-ingredient products sold in the United States from 8 pills per day (4000 mg) to 6 pills per day (3000 mg). McNeil said the change is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose.
“Acetaminophen is safe when used as directed,” said Edwin Kuffner, MD, vice president of OTC Medical Affairs and Clinical Research at McNeil Consumer Healthcare, in a July, 2011 statement. When too much is taken, however, “it can cause liver damage. Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions. McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances.”
Acetaminophen is also found in many other over-the-counter medications people can buy at the drug store and in many prescription drugs.
Common drugs include Actifed, Alka-Seltzer Plus, Benadryl, Butalbital, Co-Gesic, Contac, Darvocet, Excedrin, Fioricet, Lortab, Midrin, Norco, Percocet, Robitussin, Sedapap, Sinutab, Sudafed, TheraFlu, Unisom With Pain, Vick's Nyquil and DayQuil, Vicodin, Wygesic, and Zydone (and others).
Acetaminophen overdose may require liver transplant to save a life
Acetaminophen overdose can seriously poison and damage the liver. If the damage is severe, a liver transplant may be necessary in order to save a life.
The antidote to acetaminophen overdose is N-acetylcysteine (NAC). It is most effective when given within 8 hours of ingesting acetaminophen. Indeed, NAC can prevent liver failure if given early enough. For this reason, it is absolutely necessary that poisoning be recognized, diagnosed, and treated as early as possible.
When taken as directed, acetaminophen has a well-characterized safety profile. Recently, acetaminophen side effects have been increasingly implicated in overdose incidents that are raising its toxicity awareness.
Acetaminophen toxicity occurs with over-the-counter (OTC) preparations such as Tylenol more frequently than it does with prescription drugs.
According to the Food and drug Administration (FDA) there is no prescription medication containing acetaminophen alone. All prescription drugs containing acetaminophen are in combination with other drugs.
Acetaminophen overdose occurs in narrow margin of 2.5 or less of daily dose
Acute liver toxicity and death are the greatest of acetaminophen side effects.
The drug is capable of irreversibly destroying the liver at about 2.5 times the daily dose, and in some cases smaller doses, for some people or when taken with alcohol or when fasting.
A 2013 report, Tylenol Overdose Risk Is Staggering; Acetaminophen Safeguards Remain Insufficient, by Dominique Mosbergen, Huffington Post, quoting sources ProPublica and public radio's This American Life, called Tylenol "the deadliest over-the-counter pain reliever on the U.S. market, but its dangers are being overlooked by members of the public and health officials."
As the report points out, taking twice or sometimes even just a little bit more than the daily recommended dose of 4 grams (now 3 grams) of Tylenol over the course of a few days can result in severe illness and even death.
Quoting a report by the FDA, This American Life reporter Sean Cole says that taking even 5 grams a day of Tylenol could hurt your liver. In other words, the difference between a safe dose and a dangerous one could be just two tablets of Extra Strength Tylenol.
In contrast, one would need to take several times the recommended dose of other popular over-the-counter painkillers — 20 times the recommended dose of Ibuprofen (Advil, Motrin) and about 6 to 8 times that of aspirin— to cause toxicity, according to Cole.
Most experts and health officials agree that when taken as recommended, Tylenol and other medications containing acetaminophen are relatively risk-free.
The stages of acetaminophen overdose
Early symptoms of Tylenol or acetaminophen overdose are mild and may not be noticed until an overdose occurrence. Overdose symptoms and recovery can be broken down into four general stages:
- Stage 1 -
Includes nausea, vomiting, diarrhea and abdominal pain. Dizziness, confusion and agitation can also occur at high doses.. The drug acetylcysteine, also known as N-acetylcysteine, is an antidote to acetaminophen overdose. For maximum effect, acetylcysteine needs to be given as soon as possible after an overdose occurs.
- Stage 2 -
After 24 to 36 hours, the initial symptoms of acetaminophen toxicity will decrease, but symptoms of liver injury will appear. Liver damage is diagnosed by blood tests. Dying liver cells release enzymes into the blood stream. Serum creatinine may rise, which is a symptom of kidney failure.
- Stage 3 -
Most cases of acetaminophen toxicity bypass stage 3 and the patient will begin to recover. In some cases, however, liver failure will continue to progress after 36 to 96 hours. This becomes acute liver failure with the appearance of severe complications rapidly after the first signs of liver disease and indicates that the liver has sustained severe damage (loss of function of 80-90% of liver cells).The initial symptoms of nausea, vomiting, diarrhea and abdominal pain will return. Jaundice (appears as a yellowing of the skin or the whites of the eyes) can also occur. The patient will have low blood sugar, and the blood will not clot properly. Patients who deteriorate to this point will likely die of multiple organ failure unless a liver transplant is performed.
- Stage 4 -
People who do not experience full liver failure and recover will progress to stage 4 after four days. In the recovery phase, the liver function will return to normal over a course of one to three weeks.
Daily use of alcohol increases risk for liver damage and acetaminophen overdose
The most serious acetaminophen side effect is liver damage.
Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage.
Alcohol and Tylenol side effects: an alcohol label warning for adult Tylenol acetaminophen products states: "If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage."
The Tylenol label also instructs adults not to continue use for pain for more than 10 days, or fever for more than 3 days, unless directed by a doctor. As with all OTC analgesics, this warning is necessary so that patients and parents will seek appropriate medical evaluation of their condition if it persists beyond these time periods.
How is an acetaminophen overdose diagnosed and treated?
The following paragraphs are excerpted from drugs.com acetaminophen overdose page.
If you suspect a possible acetaminophen overdose, see your healthcare provider immediately. Tell him when you took the acetaminophen and how much you took. He may ask how long you have been taking acetaminophen. He may ask about other medicines you take and when you take them. He may ask if you have any medical problems, such as liver disease. He may ask if you drink alcohol and how much you drink. He will take your blood pressure and temperature. He may check your skin for color changes and your stomach for pain. You may also need any of the following:
- Blood tests are used to check the amount of acetaminophen in your blood.
- Liver function tests may show if your liver is working properly.
- Prothrombin time (PT) and INR rates measure how long it takes for your blood to clot. If your liver is damaged, your blood may not clot properly. You could have serious bleeding problems.
Acetaminophen overdose requires treatment begin as soon as possible. Treatment depends on how much time has passed since the overdose and if the overdose happened all at one time. You may be given:
- activated charcoal medicine to soak up the acetaminophen that is still in your stomach. Activated charcoal will make you vomit.
- You may also have your stomach pumped.
- You may be given antidote medicine to stop the effect of the overdose.
- You may also be given medicine to slow down the effects of acetaminophen.
Acetaminophen overdose as related to arthritis pain management
Arthritis pain management is a chronic issue for many people. Symptoms of moderate-to-extreme pain, inflammation, stiffness or swelling may induce patients to treat these issues without regard to overdosing. Especially when they’re not getting the results at lower doses they begin taking more.
Are you someone who sometimes exceed maximum dosage recommendations of drugs (whether acetaminophen or NSAIDS, prescription or non prescription)? If you are exceeding 3000 mg (3 grams) of acetaminophen for arthritis daily, or exceed 2000 mg (2 grams) and have three or more alcohol drinks daily, you may be at risk of overdose without knowing it.
It is important to note that liver toxicity symptoms may not be noticed until liver toxicity has already occurred.
Acetaminophen overdose usually occurs only when people take more than the maximum recommended amount. Even at maximum doses, the drug should not be taken for more than ten days unless under the order of a medical doctor.
One caution: drug side effects are more likely to compromise your health from prolonged heavy use of medications.
Use natural products to eliminate worry about acetaminophen overdose
From other pages on this website, you may be aware that my husband and I both have osteoarthritis for many years. We’ve experienced wonderful results using natural products. We’re no longer taking pharmaceutical drugs of any kind.
In the past, however, we took non-prescription acetaminophen as well as trying different NSAIDs with disappointing results. They did not sufficiently reduce pain or relieve knee joint swelling and stiffness. Worse, I am chemically sensitive. If a drug has side effects, I feel them all. Nausea and stomach problems affected me daily.
Switching to a natural approach presents a few challenges. Your long-term health is at stake. You want to be sure you’re buying safe, high quality natural products that work in your body and are not a waste of money. How do you know which brands to choose? There are so many, they all sound good--how can you be sure?
Is there a best dietary supplement company?
To find out, I developed a list of 30 questions to determine the standards of excellence in the dietary supplement industry. The answers led me to a California company established in 1956. They are the number one natural nutrition company in the U.S., an industry leader with a history of science, safety and efficacy second to none. This is the company that my husband and I trust for nutritional supplementation.
In 2003 they introduced three natural pain relief products. Each is uniquely helpful in addressing arthritis symptoms.
We no longer have to worry about such things as acetaminophen overdose, or stomach issues from NSAIDs. We’ve been very happy with the ability of these supplements to relieve our arthritis problems. Over time, they’ve dramatically improved our flexibility of motion and reduced or eliminated pain, swelling and stiffness.
Eliminate acetaminophen overdose risk with three featured natural products
Here are three natural supplements we recommend from nearly 16 years personal experience. We continue to take the first two daily, the third (pain cream) as needed.
The bold links for the supplements listed below will take you without obligation to the manufacturer's product pages for prices and more information; the ingredient links below provide additional background information on each herbal ingredient:
Glucosamine & Boswellia Joint Relief
Clinical studies indicate that glucosamine hydrochloride is most effective when arthritis symptoms are moderate to severe. Glucosamine has the ability to rebuild cartilage for joint health and comfortable movement. Formulated with the addition of clinically proven boswellia extract, this product provides faster relief in as little as one week as it lubricates and cushions joints to provide enhanced mobility and range of motion. We take every day as directed.
Boswellia and Safflower Oil Pain Relief
(Note: Use this pain relief complex for the same arthritis symptoms you use acetaminophen for)
When boswellia herb and oil from the safflower are used in combination, it creates a potent, natural arthritis pain relief supplement without gastrointestinal side effects. In studies, these two ingredients together are more effective when combined than they are separately.
Boswellia extract is a potent 5 Lox inhibitor. The safflower extract contains a potent ingredient that is a very selective Cox 2 inhibitor.
Therefore, this product is effective against both the 5 Lox and Cox 2 pain pathways--both of the major pathways--which is the only product on the market of its kind. Its formulation and synergy is so unique that there's a patent pending on this supplement. We take every day as directed (initially we took therapeutic doses because its safe and we were in constant pain--no acetaminophen overdose worries here!).
Menthol Pain Relief Rub
This topical menthol analgesic provides temporary relief (up to four hours) for minor pain associated with backache, arthritis, bruises and sprains. It offers fast absorption and deep penetration to soothe aching joints and muscles on contact. In addition to menthol, it contains a proprietary blend of natural ingredients that targets the source of discomfort and provides quick relief by improving blood circulation in the affected area.
If acetaminophen overdose is a potential issue for you, I’m happy to personally recommend each of the above supplements as a natural alternative for arthritis pain relief. Try one, two or all three and see if these safe treatments will work for you. You have everything to gain, nothing to lose.
See the 100% Satisfaction Guarantee--it’s the best in the business.
Please investigate the following two science links to understand why these products are so successful and why they are clinically proven to work:
Science Behind The Products
Acetaminophen Overdose Disclaimer: Health statements on this acetaminophen overdose page have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
Acetaminophen for Arthritis. Eliminate all possibility of acetaminophen overdose. Are you taking acetaminophen for arthritis or non prescription NSAIDs with ineffective results? Worried about your health from taking too much for too long? Read this report for answers. Click here for more details.
Acetaminophen Side Effects. Safe when taken as directed, side effects include acetaminophen overdose, acute liver toxicity, and serious adverse events including death, per report November 4, 2010. Click here for more information
Arthritis Products 3 safe natural products scientifically designed to fight pain and reduce dependency on pharmaceutical medicines. Each unique for rapid relief and joint health …. Click here for details
Find Best Company. 30 questions concerning standards of excellence help find the best dietary supplement company. One company stands out with 90 published studies in prestigious medical journals, the gold standard for natural health products. Click here for more information
Natural Arthritis Pain Relief. Millions choosing herbal supplements when conventional treatments are of concern or haven’t provided acceptable results. How to find the best pain relief….Click here for more
Joint Pain Relief. Wouldn't it be great if you could have a drug-free future with no harmful side effects and have complete control over your joint pain? It's not a dream--all of this is possible.... Click here for more on natural joint pain relief
Osteoarthritis Relief. Osteoarthritis is the most common type of arthritis. It affects joints of the knees, hips, fingers, lower spine and neck. Click here for more on osteoarthritis
Rheumatoid Arthritis Relief. Many of the natural or herbal supplements for osteoarthritis are also recommended for rheumatoid arthritis. Click here for RA natural treatment options
Vitamin Supplements There are no vitamin supplements proven to reduce symptoms of arthritis, a debilitating disease. A natural multivitamin can improve overall health and vitality. Click here for recommended multivitamin.
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