Pharmacist offers advice on use of acetaminophen
FDA advisory panel's recommendations raise concerns
Acetaminophen, an ingredient in popular over-the-counter medicines like Tylenol and some cold remedies, has been in the news and you may be wondering what it means to you and your family.
On June 30, 2009, an advisory panel recommended the Food and Drug Administration ban prescription painkillers that contain acetaminophen, including the widely prescribed Percocet and Vicodin. While acknowledging that acetaminophen is safe when used properly, the panel recommended lowering the daily recommended dose.
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The experts also made two recommendations for over-the-counter drugs with acetaminophen: Reduce the highest allowed dose in pills for adults from 500
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Dianne Witten
Retail Pharmacy Director
Duluth Clinic
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milligrams to 325 milligrams and offer only one concentration level for children. The FDA hasn’t taken action, but it usually follows the recommendations of its advisory panels.
The panel’s recommendations are aimed at preventing liver damage caused by high doses of acetaminophen. More than 400 people die and 42,000 are hospitalized every year in the United States for acetaminophen overdoses.
Accidental overdoses occur when people don’t realize the amount of acetaminophen they’re taking, especially when they combine over-the-counter drugs, says Dianne Witten, the Duluth Clinic’s Retail Pharmacy Director. For example, you may take acetaminophen tablets to treat a headache and fever while also taking a cold remedy that contains the drug. And people who take prescription medicines sometimes need to take higher and higher doses to get the same pain relief, Witten adds.
Here are Witten’s answers to some frequently asked questions about acetaminophen and the FDA advisory panel’s recent recommendations:
Q. Is acetaminophen safe?
A. Acetaminophen is generally considered safe and effective when used according to label directions. You need to read labels so you can accurately calculate the amount of acetaminophen in any medicine. And if you are taking more than one medicine, the math is even more important because too much acetaminophen could lead to serious liver damage.
Acetaminophen is the active ingredient in many over-the-counter and prescription medicines to help relieve pain and reduce fever. It is also found in combination products that treat conditions such as symptoms of colds and flu, allergy and sleeplessness.
The FDA advisory panel recommended lowering the maximum daily dose for adults from the current 4,000 milligrams. For example, if you are only taking regular strength Tylenol (325 milligrams per tablet), then you could take two tablets five times a day (3,250 milligrams). If you’re taking extra-strength Tylenol (500 milligrams per tablet), then it’s only six tablets in a day.
Q. How can I tell how much acetaminophen is in each tablet of say, Tylenol? Where do I look for that information on over-the-counter medicines?
A. Check the “Drug Facts” label under the Active Ingredients section on the package of over-the-counter medicines. Acetaminophen will be listed if it is an ingredient. You can also ask your pharmacist.
Q. Acetaminophen is recommended for children over other fever reducers and painkillers. What do I need to know when I’m giving my kids over-the-counter medicines?
A. There are several things to keep in mind to keep your child safe.
- Check the active ingredients in any medicines and over-the-counter products that your child is taking (or may take) to make sure that these products don’t include acetaminophen. Your child should not be taking more than one medicine containing acetaminophen at a time.
- Follow all directions from your child’s doctor.
- Read the “Drug Facts” label on over-the-counter medicines as well as the prescription label and follow directions.
- Choose the right medicine and dose based on your child’s weight and age. Ask your pharmacist or doctor if the product is safe for your child and what dose to give if a dose is not available on the package for your child’s weight and age.
- Always measure the medication correctly and use the dosing tool that comes with the medicine – don’t use a spoon from your kitchen as it may give the wrong amount.
Q. Is acetaminophen still recommended for pregnant women?
A. Yes, acetaminophen is considered to be safe in normal therapeutic doses for short-term use for minor pain and fever in pregnancy. Overdose or prolonged use of high therapeutic doses may result in fetal liver toxicity and other adverse effects. A normal therapeutic dose of acetaminophen is 650 milligrams every four to six hours. Be sure to talk to your healthcare provider before you take any medication, including herbs, pain relievers and over-the-counter medications for appropriate dosages and safety during pregnancy.
Q. As a precaution, should I switch to another over-the-counter pain reliever such as aspirin, ibuprofen or naproxen?
A. Acetaminophen is generally considered safer than these other over-the-counter pain relievers because it has fewer side effects. Aspirin, ibuprofen (Motrin) or naproxen (Aleve) are called nonsteroidal anti-inflammatory drugs (NSAID). NSAIDs are safe when taken according to package directions and when used occasionally.
NSAIDs may cause kidney damage, with swelling of the legs, and worsening of high blood pressure. They can also increase your risk for heart attack and stroke, so if you have cardiovascular disease, acetaminophen is probably a better idea. For some patients with certain medications, NSAID’s can cause stomach bleeding or kidney disease.
Aspirin would be a last choice medication for pain relief as it is the most likely to cause side effects. The greatest risk with aspirin is bleeding ulcers.
Always ask your doctor or pharmacist if you have questions about your medication use.
Q. What’s the danger with prescription drugs that contain acetaminophen, such as Percocet and Vicodin?
A. Some prescription medications are combination products and contain acetaminophen in addition to other pain relievers. When you take more than one medication that contains acetaminophen you must keep in mind the total amount of acetaminophen that you are taking from all sources and not exceed the total recommended dosage.
Q. What does acetaminophen do to the liver? What are the symptoms? Does it happen all at once, or does it happen over a long time?
A. Acetaminophen can cause serious liver damage if you take too much. The signs and symptoms of liver damage may not be noticed right away because they take time to appear. Early symptoms of liver damage (such as loss of appetite, nausea and vomiting) may be mistaken for something else such as the flu. Liver damage can develop into liver failure or death and therefore is a serious concern.
Q. I’m not sure if my prescriptions contain acetaminophen. How do I find out?
A. Check the prescription label information for acetaminophen or “APAP,” which is an abbreviation for acetaminophen. You can also ask your pharmacist or physician. Another option is scheduling an appointment with a pharmacist in our Medication Therapy Management Program.
Q. How does the Medication Therapy Management Program work? Who do I call?
A. During a 30- to 60-minute appointment, a Medication Therapy Management pharmacist reviews each medication you are taking to make sure they are appropriate, effective, safe and convenient for you. The pharmacist then provides you with a medication dosing schedule and recommendations to improve your drug therapy regimen. To make an appointment, call the Internal Medicine Department at (218) 786-3337 or the SMDC Heart & Vascular Center at (218) 786-3443.
Q. What should I do if I think I may be taking too much acetaminophen?
A. Never take more medication than what is recommended. Ask your pharmacist or physician how many doses you can take at one time and how many doses you can take in one day. Be sure to let your physician or pharmacist know all of the medications that you are taking.
Q. Are there medical conditions that would warrant avoiding acetaminophen?
A. Patients who have liver disease or who drink three or more alcoholic drinks every day may be at greater risk for liver damage if taking acetaminophen, even at recommended dosages. You should also talk with your doctor before taking acetaminophen if you are on the blood thinner warfarin because warfarin and acetaminophen taken together may raise your risk of bleeding.