[Posted 01/14/2014] ISSUE: FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.
took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period
took more than one acetaminophen-containing product at the same time; or
drank alcohol while taking acetaminophen products.
BACKGROUND: In January 2011 FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. FDA requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.
Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. FDA will address OTC acetaminophen products in another regulatory action. Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.
More than half of manufacturers have voluntarily complied with the FDA request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. In the near future FDA intends to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.
RECOMMENDATION: FDA recommends that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. FDA also recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.
Health care providers and pharmacists who have further questions are encouraged to contact the Division of Drug Information at 888.INFO.FDA (888-463-6332) or firstname.lastname@example.org.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Infants' Acetaminophen Product Changes
Children's acetaminophen has been available as concentrated infant drops (containing 80 mg of acetaminophen per 0.8 mL of drops or 80 mg of acetaminophen per 1 mL of drops) and as a less concentrated liquid (containing 160 mg acetaminophen per 5 mL of liquid) for older children. The Food and Drug Administration (FDA) received reports of children who were given too much acetaminophen when their caregivers mistakenly used a more concentrated product in place of a less concentrated product. To prevent this type of mistake, the concentrated infant drops will no longer be manufactured for sale in the U.S. Instead, all liquid acetaminophen products for children under 12 years of age will contain 160 mg of acetaminophen in 5 mL of medication.
Although the more concentrated products are no longer being manufactured, they may still be available in stores for some time, and you may already have these products in your home. You may continue to buy and to give your child the concentrated products, but you will need to be especially careful to follow directions so that you give your child the right amount of medication.
Before you give your child acetaminophen, check the active ingredient section in the Drug Facts label on the package to see whether the medication is an older concentrated product containing 80 mg per 0.8 mL or a newer product containing 160 mg per 5 mL. Do not assume that a product with the word ''new'' on the package contains the new concentration because the word ''new'' may also appear on older products. Read the directions on each product label carefully and give only the amount of medication listed in the instructions on that package to your child. Do not just give your child the same amount of medication that you have given in the past, follow instructions that you have read on a different package in the past, or rely on dosing instructions from the Internet, old dosing charts, or family members. If your child's doctor prescribes acetaminophen for your child, be sure that he or she knows which product you will be using so that he or she can prescribe the correct dose.
If you have an older concentrated product, it will probably come with a dropper, and if you have a newer product, it may come with an oral syringe. Only measure your child's medication with the device included in that package . Do not switch measuring devices between the old and new acetaminophen liquid products.
Talk to your pharmacist or doctor if you have questions about these acetaminophen product changes.
Taking too much acetaminophen can cause liver damage, sometimes serious enough to require liver transplantation or cause death. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen.
not take more than one product that contains acetaminophen at a time. Read the labels of all the prescription and nonprescription medications you are taking to see if they contain acetaminophen. Be aware that abbreviations such as APAP, AC, Acetaminophen, Acetaminoph, Acetaminop, Acetamin, or Acetam. may be written on the label in place of the word acetaminophen. Ask your doctor or pharmacist if you don't know if a medication that you are taking contains acetaminophen.
take acetaminophen exactly as directed on the prescription or package label. Do not take more acetaminophen or take it more often than directed, even if you still have fever or pain. Ask your doctor or pharmacist if you do not know how much medication to take or how often to take your medication. Call your doctor if you still have pain or fever after taking your medication as directed.
be aware that you should not take more than 4000 mg of acetaminophen per day. If you need to take more than one product that contains acetaminophen, it may be difficult for you to calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist to help you.
tell your doctor if you have or have ever had liver disease.
not take acetaminophen if you drink three or more alcoholic drinks every day. Talk to your doctor about the safe use of alcohol while you are taking acetaminophen.
stop taking your medication and call your doctor right away if you think you have taken too much acetaminophen, even if you feel well.
Talk to your pharmacist or doctor if you have questions about the safe use of acetaminophen or acetaminophen-containing products.
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Acetaminophen comes as a tablet, chewable tablet, capsule, suspension or solution (liquid), drops (concentrated liquid; removed from U.S. market), extended-release (long-acting) tablet, and orally disintegrating tablet (tablet that dissolves quickly in the mouth), to take by mouth, with or without food. Acetaminophen also comes as a suppository to use rectally. Acetaminophen is available without a prescription, but your doctor may prescribe acetaminophen to treat certain conditions. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
If you are giving acetaminophen to your child, read the package label carefully to make sure that it is the right product for the age of the child. Do not give children acetaminophen products that are made for adults. Some products for adults and older children may contain too much acetaminophen for a younger child. Check the package label to find out how much medication the child needs. If you know how much your child weighs, give the dose that matches that weight on the chart. If you don't know your child's weight, give the dose that matches your child's age. Ask your child's doctor if you don't know how much medication to give your child.
Acetaminophen comes in combination with other medications to treat cough and cold symptoms. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.
Swallow the extended-release tablets whole; do not split, chew, crush, or dissolve them.
Place the orally disintegrating tablet ('Meltaways') in your mouth and allow to dissolve or chew it before swallowing.
Shake the suspension well before each use to mix the medication evenly. Always use the measuring cup or syringe provided by the manufacturer to measure each dose of the solution or suspension. Do not switch dosing devices between different products; always use the device that comes in the product packaging.
Remove the wrapper.
Dip the tip of the suppository in water.
Lie down on your left side and raise your right knee to your chest. (A left-handed person should lie on the right side and raise the left knee.)
Using your finger, insert the suppository into the rectum, about 1/2 to 1 inch (1.25 to 2.5 centimeters) in infants and children and 1 inch (2.5 centimeters) in adults. Hold it in place for a few moments.
Stand up after about 15 minutes. Wash your hands thoroughly and resume your normal activities.
Stop taking acetaminophen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, including redness or swelling, your pain lasts for more than 10 days, or your fever gets worse or lasts more than 3 days. Also stop giving acetaminophen to your child and call your child's doctor if your child develops new symptoms, including redness or swelling, or your child's pain lasts for longer than 5 days, or fever get worse or lasts longer than 3 days.
Do not give acetaminophen to a child who has a sore throat that is severe or does not go away, or that occurs along with fever, headache, rash, nausea, or vomiting. Call the child's doctor right away, because these symptoms may be signs of a more serious condition.
Acetaminophen may also be used in combination with aspirin and caffeine to relieve the pain associated with migraine headache.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
This medication is usually taken as needed. If your doctor has told you to take acetaminophen regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Acetaminophen may cause side effects.
red, peeling or blistering skin
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
Acetaminophen may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
loss of appetite
unusual bleeding or bruising
pain in the upper right part of the stomach
yellowing of the skin or eyes
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking acetaminophen.
Ask your pharmacist any questions you have about acetaminophen.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
§ These products are not currently approved by the FDA for safety, effectiveness, and quality. Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. Please see the FDA website for more information on unapproved drugs (http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213030.htm) and the approval process (http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm).
Last Revised - 01/15/2014
AHFS® Consumer Medication Information. © Copyright, 2014. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.