Even a small amount of Tylenol and similar generic brands of acetaminophen could cause liver damage. The FDA's newest guidelines say the maximum daily dose listed on Tylenol and dozens of other painkillers should be reduced to help curb deadly overdoses, according to several news announcements published by the Associated Press on June 30, 2009.
As far back as 2006, studies warned consumers that acetaminophen, the main ingredient in Tylenol and similar generic brands with the same ingredients is dangerious. This comes in the face of the fact that Tylenol is Americans' over-the-counter painkiller of choice. Acetaminophen overdose is also the leading cause of acute liver failure.
According to the 2006 article, "Tylenol Found to Cause Liver Damage, Even in Small Doses," published July 5, 2006 in Natural News, "Healthy adults who took the maximum dose of Tylenol for two weeks were found to have liver damage," according to a study appearing in the July 2006 issue of the Journal of the American Medical Association. See, "Aminotransferase Elevations in Healthy Adults Receiving 4 Grams of Acetaminophen Daily: A Randomized Controlled Trial," Paul B. Watkins; Neil Kaplowitz; John T. Slattery; Connie R. Colonese; Salvatore V. Colucci; Paul W. Stewart; Stephen C. Harris, JAMA. 2006;296:87-93.
Three years ago, researchers instructed 106 study participants to take 4 grams of Tylenol (eight extra-strength tablets) a day for two weeks, with some taking only Tylenol, and some taking Tylenol combined with an opioid painkiller. The rest of the participants were given a placebo. As a result of the study, close to 40 percent of the participants taking Tylenol or the Tylenol/opioid combination showed abnormal liver test results that indicated liver damage, while those taking the placebo showed no damage.
According to the 2006 study, as reported in Natural News, co-author, Dr. Neil Kaplowitz of the University of Southern California advised, "I would urge the public not to exceed 4 grams a day. This is a drug that has a rather narrow safety window." Kaplowitz added that heavy drinkers should not exceed 2 grams a day.
Back in 2006, Tylenol maker McNeil Consumer & Specialty Pharmaceuticals said it had "conducted its own research that tracked high-dose Tylenol users over longer periods than the Kaplowitz study, and found that its product did not lead to liver disease," according to the 2006 Natural News article.
Kaplowitz and co-author Dr. Paul Watkins of the University of North Carolina were hired by Purdue Pharma, which makes the prescription painkiller OxyContin, to see why people testing a drug containing acetaminophen and the opiate hydrocodone were having abnormal liver tests. Contrary to the researchers' theories, they found that acetaminophen was the culprit.
A new 2009 study in the Journal of the American Medical Association determined that it only takes fourteen days for healthy adults to sustain liver damage from acetaminophen use, according to the article, "Acetaminophen Causes Liver Damage in as Little as 2 Weeks," by Christine O'Brien, posted on June 16, 2009, on the Healthier Talk.com site.
Also, just like in the 2006 study with acetaminophen, not one person who received the placebo showed any signs of liver damage in the 2009 study as well as the 2006 study. The people taking acetaminophen, however, started having abnormal liver test results—an indication of damage. In the 2009 study, the study's co-author mentioned that taking over 4-grams of acetaminophen should be avoided. But the 2006 study revealed that even at smaller doses, liver damage could occur.
As a result of the latest 2009 study, The FDA, recommended limiting the maximum daily dose of drugs containing acetaminophen down to 3,250 milligrams per day, and asked for stronger labels warning of liver side effects.
There was also an updated guideline issued by the American Geriatrics Society (AGS) for NSAIDs in May, 2009. See, "New Pain Guideline for Older Patients: Avoid NSAIDs, Consider Opioids,"JAMA. 2009;302(1):19. According to this study, "Physicians treating patients aged 75 years or older for chronic pain should avoid using nonsteroidal anti-inflammatory drugs (NSAIDs)."
According to the 2009 NSAID study published in the current issue of JAMA, NSAIDs should be "considered rarely, and with extreme caution, in highly selected individuals," the new guideline states, contradicting the AGS's 2002 guideline.
The article, "New Pain Guideline for Older Patients: Avoid NSAIDs, Consider Opioids,"JAMA. 2009;302(1):19 noted that, "The new recommendation reflects evidence about serious cardiovascular and gastrointestinal tract risks associated with this class of drugs that has emerged since 2002," said Bruce Ferrell, MD, chair of the panel that created new guideline and professor of medicine and geriatrics at the University of California, Los Angeles.
"These drugs also may complicate the treatment of common conditions in this population, such as hypertension and congestive heart failure.The study involved 106 people taking 4 grams of acetaminophen (the active ingredient in Tylenol, Excedrin and other pain killers) a day for two weeks. Four grams is the maximum daily dose recommended by the manufacturer, so we're not even talking about an "abuse" situation here."
Acetaminophen and Liver Injury: Q & A for Consumers
The Food and Drug Administration (FDA) says taking acetaminophens are still "generally safe" when the manufacturer's directions are followed according to the labeling. Government experts have issued new guidelines for consumers based on the results of continuing studies of liver damage even at small doses of acetaminopens. And now, the new guidelines ask for a cut-off level of even smaller doses.
On June 29 and 30, 2009, FDA held an advisory committee meeting in Adelphi, Md., about how to address the problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription products. For more information about the meeting, visit the Advisory Committee Web page.
An important question for the consumer is that when the FDA says, "generally safe," does it mean safe or maybe safe for some people and not so safe for others who can't see the small print to read the label on the bottle or who don't read English? Or does "generally safe" mean safe for some based on age and health conditions? Let's look at the updated guidelines issued by government experts at the FDA.
According to FDA's Consumer Updates site, "Acetaminophen is the generic name of a drug found in many common brand name OTC products such as Tylenol, as well as prescription products such as Vicodin and Percocet. Acetaminophen is an important drug, and its effectiveness in relieving pain and fever is widely known."
FDA guidelines note, "This drug is generally considered safe when used according to the directions on its labeling. But taking more than the recommended amount can cause liver damage, ranging from abnormalities in liver function blood tests, to acute liver failure, and even death." Below is the FDA's question and answer information on the latest guidelines for acetaminophen.
Q: What is acetaminophen?
A: Acetaminophen (pronounced: a?seet·aminofen), is an active ingredient found in many OTC and prescription medicines to help relieve pain and reduce fever.
It is also found in combination with other active ingredients, called combination medicines, which treat conditions such as:
- symptoms of colds and flu
- allergy
- sleeplessness
Medicines containing acetaminophen are available in many forms, including drops, syrups, capsules, and pills.
Many people call OTC acetaminophen by a brand name, Tylenol. Others may know Percocet or Vicodin, which are prescription brand names that contain acetaminophen and other active ingredients to help relieve pain.
You might see acetaminophen abbreviated as “APAP” on prescription medicines.
In other countries, acetaminophen may have a different name. For example, acetaminophen is known as paracetamol in the United Kingdom.
Q. Are there risks from taking too much acetaminophen?
A: Yes, acetaminophen can cause serious liver damage if you take too much. It is very important to follow your doctor’s directions and the directions on the medicine label.
You may not notice the signs and symptoms of liver damage right away because they take time to appear. Or, you may mistake early symptoms of liver damage (for example, loss of appetite, nausea, and vomiting) for something else, like the flu. Liver damage can develop into liver failure or death over several days.
Acetaminophen is generally safe when taken as directed. To lower your risk of liver damage make sure you do the following:
- Follow dosing directions and never take more than directed; even a small amount more than directed can cause liver damage.
- Don’t take acetaminophen for more days than directed.
- Don’t take more than one medicine that contains acetaminophen at a time. For example, your risk of liver damage goes up if you take a medicine that contains acetaminophen to treat a headache, and while that medicine is still working in your body, you take another medicine that contains acetaminophen to treat a cold.
Q: How can I tell which medicines contain acetaminophen?
A: Medicines have ingredients listed on their labels. On OTC medicines, check the “Drug Facts” label under the section called Active Ingredients. If your medicine contains acetaminophen, it will be listed in this section. On prescription medicine containers, the label will say “acetaminophen” or “APAP.”
Q: When should I talk to a doctor before taking acetaminophen?
A: Talk to your doctor before taking acetaminophen if you
- drink alcohol (three or more drinks every day)
- have liver disease
Under these conditions, taking acetaminophen puts you at greater risk of getting liver damage, even when taking acetaminophen at the recommended dose.
If you take the blood thinner warfarin, you should also talk to your doctor before taking acetaminophen because taking warfarin and acetaminophen together may raise your risk of bleeding.
Q: How can I safely take acetaminophen?
A: Follow this advice to take acetaminophen safely:
- Read all the information given to you by your doctor and follow directions.
- Read the information on the OTC “Drug Facts” label or on the prescription label and follow directions.
- Be sure you understand the following:
- the dose, which is how much acetaminophen you can take at one time
- how many hours you must wait before taking another dose of acetaminophen
- how many doses of acetaminophen you can take safely each day
- when to stop taking acetaminophen and ask a doctor for help - Never take more than directed, even if your pain or fever isn’t any better. Taking more acetaminophen than directed can put you at risk for liver damage.
- Never take more than one medicine that contains acetaminophen. Check the active ingredients of all your medicines to make sure you are taking no more than one medicine containing acetaminophen at a time.
Q: How can I safely give acetaminophen to my child?
A: You can safely give acetaminophen to infants, children, and teenagers if you
- Check the active ingredients in the other medicines that your child is taking (or that your child may take) to make sure they don’t contain the active ingredient acetaminophen. Your child should never be taking more than one medicine containing acetaminophen at a time.
- Read all the information given by your child’s doctor and follow directions.
- Read the information on the OTC “Drug Facts” label or on the prescription label and follow directions.
- Choose the right medicine based on your child’s weight and age. On OTC medicines, the Directions section of the “Drug Facts” label tells you:
- if the medicine is right for your child
- how much medicine to give
- how many hours you must wait before giving another dose
- when to stop giving acetaminophen and ask a doctor for help
If a dose for your child’s weight or age is not listed on the label, or you can’t tell how much to give, ask your pharmacist or doctor what to do.
- Use the measuring tool that comes with the medicine. It will give the exact dose. If you don’t have the right measuring tool, ask a pharmacist.
- Don’t use a spoon that’s meant to be used for cooking or eating. A spoon should not be used to measure medicine because it may give the wrong amount.
- Never give more than one medicine that contains acetaminophen. If you give more, it could harm your child.
Prevent medicine accidents:
- Keep a record of the medicines you give your child. Write down the dose and time when you give the medicine. This will help everyone who cares for your child know how much medicine your child has had. This will help everyone avoid giving an extra dose by mistake.
- Keep medicine where it can’t be seen or reached by children and pets; a locked box, cabinet, or closet is best.
Q: What should I do if the pain or fever doesn’t get better after taking acetaminophen as directed?
A: Take the medicine only as directed. Don’t take more. If the medicine doesn’t help you feel better, talk to your doctor, nurse, or pharmacist.
Q: What should I do if I took too much acetaminophen? What should I do if I gave too much acetaminophen to my child?
A: Don’t wait! Call 9-1-1 or Poison Control at 1-800-222-1222 right away to find out what to do. The signs or symptoms of liver damage may not be noticeable for hours or even days after taking acetaminophen. By the time you notice changes, the liver damage may be severe and could lead to death.
Q: Where can I get more information on acetaminophen?
A:
- Talk to a doctor, nurse, or pharmacist.
- Visit FDA’s consumer Web pages:
Don’t Overdo It with Acetaminophen (video)
Safe Use of Over-the-Counter Pain Relievers and Fever Reducers
A Guide to Safe Use of Pain Medicine
- Contact the FDA at 1-888-INFO-FDA.
- Or, e-mail questions to FDA at druginfo@fda.hhs.gov
The FDA's question and answer guidelines also appear on FDA’s Consumer Updates page, posted on June 24, 2009, which features the latest on all FDA-regulated products. Also view the informational uTube video below on this subject of guidelines for safe use of over-the-counter pain relievers and fever reducers, particularly acetaminophen.
Comments
Tylenol is the ONLY OTC headache med I can take. I'm highly allergic to everything else. I agree with closely following the directions on the bottle but I really hope tylenol is never taken off the shelves completely. Use some common sense with this and all medications good lord! For those of us with med allergies what are we suppose to do?
Great article! Very comprehensive!
xRenea, you might want to consider herbs, which have fewer side effects than meds. White willow is one that works great for headache. Others to look into include angelica, astragalus. celery, devil's claw, gingko, elderberry, marjoram. Tense muscles often lead to headaches, so a good massage could do wonders...Just some ideas...
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