By Dr. Mercola
Tylenol has been featured in the news again, as its risks are becoming more widely acknowledged. Consumer Reports also criticized the US Food and Drug Administration is not doing enough to keep consumers safe from potentially serious side effects.
As noted by Time Magazine,1 prescriptions for opioid painkillers have risen by an incredible 300 percent over the past 10 years, but the excessive use of over-the-counter (OTC) painkillers like acetaminophen is equally troublesome:
"Acetaminophen, which includes Tylenol and other generic brands, causes more than 80,000 emergency room visits each year because people often aren't aware they're taking too much."
Part of the problem is that acetaminophen can be found in more than 600 different drugs, from cold and allergy medications, to fever reducers and sleeping pills, and many people fail to add all these sources together when taking several different remedies and/or prescription drugs.
Many of the dangers associated with narcotic painkillers (opioids) are also related to these drugs being mixed with acetaminophen.
New Guidelines for High-Dose Prescription Acetaminophen Have Been Issued
Acetaminophen overdose is the leading cause for calls to Poison Control Centers across the US—more than 100,000 instances per year—and acetaminophen poisoning is responsible for nearly half of all acute liver failure cases in the US.2
Acetaminophen overdoses are also responsible for more than 150 deaths each year in the US.3, 4 A major problem is that while acetaminophen is considered safe when taken as recommended, the margin between a safe dose and a potentially lethal one is very small.
Taking just 25 percent more than the daily recommended dose—the equivalent of just two extra strength pills per day—can cause liver damage after just a couple of weeks of daily use.5
When taken all at once, just under four times the maximum daily dose can be lethal! Previous research6 has also shown that taking just a little more than the recommended dose over the course of several days or weeks (referred to as "staggered overdosing") can be more risky than taking one large overdose.
In 2009, the FDA finally added a warning to acetaminophen-containing drugs alerting consumers to its potential for causing liver damage—a move recommended by an expert panel all the way back in 1977! Then, in 2013, the agency warned that acetaminophen may cause three serious skin reactions; two of which typically require hospitalization and can be fatal.
Most recently, the FDA issued a statement7, 8 urging doctors and other health professionals to stop prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit.
Consumer Report Warns of Inconsistent Dosing Advice
According to the FDA, more than half of manufacturers have voluntarily complied with their recommendation and have reduced the amount of acetaminophen per dose. However, it's important to know that prescription products containing more than the recommended maximum of 325 mg of acetaminophen still remain on the market.
If you're taking more than one acetaminophen-containing medication, remember to add up the dose you're getting from all sources! Also beware that the dosing advice on various medications can be quite inconsistent. This particular problem was recently highlighted by Consumer Reports:9
"Advice to 'take only as directed' doesn't cut it when the advice is confusing and conflicting. And with acetaminophen, the advice is exactly that.
For example, the FDA has lowered the maximum per-pill dose of prescription acetaminophen, but it hasn't taken the same step for over-the-counter products. And OTC drugmakers have wildly different notions of what people can take:
Some labels advise taking no more than 1,000 milligrams of acetaminophen daily; others set the limit almost four times as high...'[T]he FDA should fulfill its role to protect consumers by taking strong steps to reduce the dangers, starting by reconsidering its approval of Zohydro ER and finally establishing consistent standards for acetaminophen.'"
Factors That Increase Risks Associated with Acetaminophen
Please beware that your risk of severe liver injury and/or death increases if you:
- Take more than one regular strength (325 mg) acetaminophen when combined with a narcotic analgesic like codeine or hydrocodone
- Take more than the prescribed dose of an acetaminophen-containing product in a 24-hour period
- Take more than one acetaminophen-containing product at the same time. Make sure to read the list of ingredients on any other over-the-counter (OTC) or prescription drug you take in combination.
- Drink alcohol while taking an acetaminophen product. Research10 suggests that acetaminophen also significantly increases your risk of kidney dysfunction if taken with alcohol—even if the amount of alcohol is small.11
Combining alcohol with acetaminophen was found to raise the risk of kidney damage by 123 percent, compared to taking either of them individually. Besides alcoholics,12 young adults are particularly at risk as they're more likely to consume both.
Tylenol Doesn't Work for Back Pain, Study Finds
An estimated 80 percent of Americans will suffer from chronic back pain at some point in life. Some 25-30 percent end up struggling with persistent or chronic back pain, leading many to reach into their medicine cabinet for relief. However, according to recent research,13 taking acetaminophen for back pain is no more effective than taking a placebo. As reported by Fortune Magazine:14
"Conducted at hundreds of clinics in Sydney, Australia, the study tracked 1,652 individuals with lower back pain for four weeks. They were given either paracetamol (what acetaminophen is known as overseas), or a placebo.
In the end, researchers found there was almost no difference in the number of days required to recover between the two groups; the median time to recovery was 17 days in the regular paracetamol group, 17 days in the as-needed paracetamol group, and 16 days in the placebo group."
According to lead author Dr. Christopher Williams, "The results suggest we need to reconsider the universal recommendation to provide paracetamol [acetaminophen] as a first-line treatment for low-back pain..." Unfortunately, back pain is also one of the leading causes for opioid addiction, which now claims the lives of 17,000 Americans each year. Prescription opioids have also become the latest "gateway drugs" to illicit drug use. It's important to realize that prescription medications like hydrocodone and oxycodone are opioid derivatives—just like heroin.
The risk of addiction to these drugs is very high—a fact noted in a lawsuit filed by Chicago and two California counties against five drugmakers of OxyContin.15 In their suit, they charge the drug companies with contributing to an epidemic of drug abuse. In Santa Clara County, the death rate for opioid overdoses has tripled in the last decade, and according to assistant County Counsel Danny Chou, this is all due to a "decades-long marketing plan" by drug companies "to create a market for these drugs that never should have existed" in the first place.
Consumer Reports Guide to Safe Opioid Use
Earlier this summer, US Attorney General Eric Holder announced his office is taking steps to address the mounting problem of opioid addiction. This effort includes but is not limited to tracking drug overdose trends, educating health care professionals and the public about prescription drug abuse, and promoting programs shown to prevent such abuse. The federal government will also require manufacturers of extended-release and long-acting opioids to provide prescribers with educational programs explaining the risks and benefits of opioid therapy, and how to select appropriate candidates for such therapy.
While I urge you to seriously reconsider the need for a narcotic pain reliever, there are times when they may be warranted short-term. In such cases, please make sure you adhere to the following common sense advice issued by Consumer Reports16 to limit your risk for adverse effects, accidents, and addiction as much as possible:
Read the label and never exceed the maximum dose. Take the smallest dose necessary for as short a time as possible Do not drive when taking opioids Do not mix with alcohol, and do not take in combination with drugs without consulting with your doctor first. Taking a narcotic pain reliever with sleeping pills is one of the most deadly combinations Make sure to keep the drugs in a locked medicine cabinet to prevent misuse by family or other visitors. Properly discard unused pills by taking them back to the pharmacy If you have sleep apnea, opioids can exacerbate the condition with potentially lethal consequences. Also, if you have a cold, asthma, or bronchitis, you may need to lower your dose until you've recovered, as opioids tend to interfere with breathing Make sure you're under regular monitoring by your doctor
NAC Helps Counteract Acetaminophen Hazards
As for making acetaminophen use safer, N-acetyl cysteine (NAC), which is an antidote for acetaminophen toxicity, is well worth knowing about. NAC is administered as part of standard care in cases of acetaminophen overdose.17, 18 While I generally do not recommend using acetaminophen-containing drugs for minor aches and pains, they are sometimes necessary to temporarily suppress severe pain, such as post-surgical pain. For those instances, I recommend taking it along with NAC.
It is believed that the liver damage acetaminophen causes is largely due to the fact that it can deplete glutathione, an antioxidant compound secreted by your liver in response to toxic exposure. Glutathione also helps protect your cells from free radical damage. If you keep your glutathione levels up, the damage from the acetaminophen may be largely preventable. NAC is the rate-limiting nutrient for the formation of the intracellular antioxidant glutathione, which is why it's such an effective antidote. Mortality due to acetaminophen toxicity has been shown to be virtually eliminated when NAC is promptly administered in cases of acetaminophen overdose. So whether you are taking Tylenol in prescription or over-the-counter form, I strongly suggest taking NAC along with it.
Non-Drug Options for Pain Relief
With all the health risks associated with acetaminophen and opioid painkillers, I strongly recommend exhausting other options before you resort to these drugs. Below I list some non-drug alternatives for the treatment of pain. These options can often provide excellent pain relief for mild pain, without any of the health hazards that prescription (and even over-the-counter) painkillers carry. This list is in no way meant to represent the only approaches one can use. These are just some of the best strategies that I know of. If you are in pain, please try these first, before even thinking about prescription painkillers of any kind.
- Medical cannabis has a long history as a natural analgesic19 and is frequently not used by many who read this site and seek to justify their use of opioids. At present, 20 US states have legalized cannabis for medical purposes. Its medicinal qualities are due to high amounts (about 10-20 percent) of cannabidiol (CBD), medicinal terpenes, and flavonoids. As discussed in this previous post, varieties of cannabis exist that are very low in tetrahydrocannabinol (THC)—the psychoactive component of marijuana that makes you feel "stoned"—and high in medicinal CBD.
The Journal of Pain,20 a publication by the American Pain Society, has a long list of studies on the pain-relieving effects of cannabis and would certainly seem worth the effort for anyone with chronic pain to utilize. One needs to seek a knowledgeable cannabis physician as many have no idea of the proper dosing. If you are seriously considering medical cannabis for pain, it is imperative that you view my interview with Dr. Alan Frankel, who is one of the leading medical cannabis physicians in the US. He can do consultations on the phone if one needs specific questions answered.
- Eliminate or radically reduce most grains and sugars from your diet. Avoiding grains and sugars will lower your insulin and leptin levels and decrease insulin and leptin resistance, which is one of the most important reasons why inflammatory prostaglandins are produced. That is why stopping sugar and sweets is so important to controlling your pain and other types of chronic illnesses.
- Take a high-quality, animal-based omega-3 fat. My personal favorite is krill oil. Omega-3 fats are precursors to mediators of inflammation called prostaglandins. (In fact, that is how anti-inflammatory painkillers work, they manipulate prostaglandins.)
- Emotional Freedom Techniques (EFT) is a drug-free approach for pain management of all kinds. EFT 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 rebalance your energy system, which tends to dissipate pain.
- K-Laser Class 4 Laser Therapy. If you suffer pain from an injury, arthritis, or other inflammation-based pain, I'd strongly encourage you to try out K-Laser therapy. It can be an excellent choice for many painful conditions, including acute injuries. By addressing the underlying cause of the pain, you will no longer need to rely on painkillers. K-Laser is a class 4 infrared laser therapy treatment that helps reduce pain, reduce inflammation, and enhance tissue healing—both in hard and soft tissues, including muscles, ligaments, or even bones.
The infrared wavelengths used in the K-Laser allow for targeting specific areas of your body, and can penetrate deeply into the body to reach areas such as your spine and hip. For more information about this groundbreaking technology, and how it can help heal chronic pain, please listen to my previous interview with Dr. Harrington.
- Chiropractic. Many studies have confirmed that chiropractic management is much safer and less expensive than allopathic medical treatments, especially when used for pain, such as low-back pain. Qualified chiropractic, osteopathic, and naturopathic physicians are reliable, as they have received extensive training in the management of musculoskeletal disorders during their course of graduate healthcare training, which lasts between four to six years. These health experts have comprehensive training in musculoskeletal management.
- Acupuncture can also effectively treat many kinds of pain. Research has discovered a "clear and robust" effect of acupuncture in the treatment of back, neck, and shoulder pain, osteoarthritis, and headaches.
- Physical and massage therapy has been shown to be as good as surgery for painful conditions such as torn cartilage and arthritis.
- Ginger: This herb has potent anti-inflammatory activity and offers pain relief and stomach-settling properties. Fresh ginger works well steeped in boiling water as a tea or grated into vegetable juice.
- Curcumin: In a study of osteoarthritis patients, those who added 200 mg of curcumin a day to their treatment plan had reduced pain and increased mobility.21 A past study also found that a turmeric extract composed of curcuminoids blocked inflammatory pathways, effectively preventing the overproduction of a protein that triggers swelling and pain.22
- 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.
- 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.
- 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, Foundation Training, massage, meditation,23 hot and cold packs, and other mind-body techniques can also result in astonishing pain relief without any drugs.