FDA issues new warnings about acetaminophen

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acetaminophenThe Food and Drug Administration is asking doctors to stop prescribing combination medications that contain more than 325 milligrams of acetaminophen per pill, because of concerns about liver damage.

The agency says it soon will withdraw approval for any of those medications containing more than 325 mg of acetaminophen. It also said that it is planning new regulatory action on over-the-counter acetaminophen, but did not give details. 

Overdoses from acetaminophen send 56,000 people to emergency rooms and kill about 500 each year, according to FDA. The drug is a leading cause of acute liver failure.

Below are  five things all consumers should know about this particular pain killer:

1. It’s not great for muscle pain. 

Acetaminophen is part of a class of painkillers called non-opioid analgesics, which are used to treat mild or moderate pain. These include acetaminophen, ibuprofen and aspirin.

Most non-opiod analgesics work in the peripheral nervous system, or the nerves not included in your brain and spinal cord. But scientists believe acetaminophen works primarily in the central nervous system, attacking a slightly different form of the enzyme called COX-3.  So, acetaminophen is great for headaches, fever and minor aches and pains but won’t reduce inflammation of the muscles.

2. It’s found in more than Tylenol.

Though many people know that acetaminophen in the active ingredient in Tylenol, it’s also found in many other over-the-counter drugs including (but not limited to) some Excedrin, Robitussin and Sudafed products.  Acetaminophen is also used in combination with opioids in prescription pain medications such as Percocet, Vicodin and Tylenol with codeine.

To find out whether your medications contain acetaminophen, read the drug label and look for the word “acetaminophen” or the letters “APAP,” an abbreviation sometimes used for the drug.

3. It’s easy to accidentally take too much.

The FDA has set the recommended daily maximum for adults at 4,000 milligrams. It’s easier to reach this limit than you might think; one gel tablet of Extra Strength Tylenol, for example, contains 500 mg.  Taking too much acetaminophen can lead to liver failure or death.

Consumers should not take more than the prescribed dose of any medication that contains acetaminophen, according to the FDA, and should avoid taking more than one acetaminophen product at a time.

4. It’s not the best way to fight a hangover.

Most of us have popped a couple of painkillers after a night out to ward off a hangover. Taking acetaminophen with alcohol, even in small amounts, can increase your risk of liver damage and/or kidney disease.

You may not notice the signs of liver damage right away; some symptoms like loss of appetite and nausea can be mistaken for the flu (or that hangover). If you suspect you’re at risk, contact your doctor immediately.

5. It’s not like “a spoonful of sugar.”

Children can take acetaminophen to fight pain or a fever, but parents should read drug labels carefully to avoid dosage errors.  The “directions” section of the label tells you whether the medicine is right for your child and how much to give.

Liquid acetaminophen for infants and children is now sold in the same concentration: 160 mg/5 mL. That means infants need less; acetaminophen products for infants are usually packaged with an oral syringe instead of a dropper.

Parents should always use the measuring tool that comes with the medication, the FDA says — never a kitchen spoon.

Related Stories: U.S. Marshals seize more than $2 million in dietary supplements containing hazardous DMAA & FDA takes action to speed safety information updates on generic drugs

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