Entries in Acetaminophen (6)


FDA Warns About Acetaminophen Dosage for Children

Hemera/Thinkstock(WASHINGTON) -- Parents with children who take liquid acetaminophen are being asked to take the time to read the label accompanying the drug before giving it to their kids.

The warning comes from the Food and Drug Administration (FDA), which says a less concentrated form of the drug is now hitting store shelves and parents are being asked to double-check the dosage since giving a child too little can cause the medication to be ineffective, while too much cause serious side effects and may even lead to death.

"Be very careful when you’re giving your infant acetaminophen" Carol Holquist, director of FDA’s Division of Medical Error Prevention and Analysis, said in a statement.

Acetaminophen is used for relief with fever, toothache, as well as cold and fever, among other illnesses.

The FDA warns that while some manufacturers are taking the precautionary step to only offer the less concentrated version of the medicine, parents must be aware that both the stronger and weaker forms are still on store shelves.

So, to help parents and caregivers ensure that they give children the right dosage of acetaminophen, the FDA is offering the following guidelines:

  • Read the Drug Facts label on the package very carefully to identify the concentration of the liquid acetaminophen, the correct dosage, and the directions for use.
  • Do not depend on a banner proclaiming that the product is “new.” Some medicines with the old concentration also have this headline on their packaging.
  • Use only the dosing device provided with the purchased product in order to correctly measure the right amount of liquid acetaminophen.
  • Consult your pediatrician before giving this medication and make sure you’re both talking about the same concentration.

Copyright 2011 ABC News Radio


New Dosing Instructions for Tylenol Products

Brendan Smialowski/Getty Images(FORT WASHINGTON, Pa.) – McNeil Consumer Healthcare Division of McNeil-PC, Inc. announced plans Thursday for new dosing instructions lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the U.S. from eight pills per day (4,000 mg) to six pills per day (3,000 mg).

The change is designed to help encourage safer acetaminophen use with the intention of reducing risk of accidental overdose.

Acetaminophen is the active ingredient in Tylenol and can be found in more than 600 over-the-counter and prescription medications, such as Sudafed Triple Action, NyQuil, Percocet and Vicodin. It is used by more than 50 million Americans each week to treat conditions such as pain, fever, and cold and flu symptoms.

“Acetaminophen is safe when used as directed,” said Edwin Kuffner, M.D., vice president of OTC Medical Affairs and Clinical Research at McNeil Consumer Healthcare. “But, when too much is taken, it can cause liver damage.  Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions.  McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances.”

McNeil says the new dosing instructions will appear on Extra Strength Tylenol packages in the U.S. beginning in the fall of 2011. Additionally, McNeil will be lowering the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen-containing products.

Copyright 2011 ABC News Radio


FDA Panel Recommends Dosing Changes for Children's Acetaminophen

Comstock/Thinkstock(WASHINGTON) -- When children have a fever or pain, the first over-the-counter medicine many parents reach for is acetaminophen, more commonly known as Tylenol.

A U.S. Food and Drug Administration advisory panel is recommending changes in determining how much of the medicine children should get, and adding dosage instructions for children under 2 years of age.

Currently, liquid formulas give instructions for children ages 2 to 12.  But the advisory panel unanimously agreed the dosage should be based on weight, not age.  While some product labels provide dosing information with both age and weight tables, the panelists emphasize weight is a more accurate measure and the preferred approach.

For children younger than 2, parents are advised to ask a doctor to avoid an overdose and rule out dangerous infections, which could be the cause of fevers.

Although safe when used as directed, children's acetaminophen accounted for 7,500, or nearly three percent, of emergencies reported to poison control centers last year.

Overdoses of the drug, most common among children under age 2, have increased in the last ten years.

While not obligated to do so, the FDA is expected to adopt the panel's recommendations.

Copyright 2011 ABC News Radio


OTC Drug Makers to Stop Producing Infant Doses of Acetaminophen

Comstock/Thinkstoc(WASHINGTON) -- The Consumer Healthcare Products Association (CHPA) announced Thursday on behalf of over-the-counter (OTC) drug manufacturers that parents will no longer find acetaminophen in concentrated infant drops at their local drugstores. Pediatric liquid acetaminophen for children 12 and under will only be sold in a 160 mg/5L concentration.

"CHPA member companies are voluntarily making this conversion to one concentration to make it easier for parents and caregivers to appropriately use single-ingredient liquid acetaminophen," said the CHPA President Scott Melville in a statement Thursday.

Melville added that the association is committed to educating parents and caregivers about the proper amounts and methods for giving these medications to their children.

While OTC manufacturers will continue to include cups with these medications for older children, they will also provide syringes with dose restrictors in products for infants.  Earlier this week, the FDA release guidelines recommending manufacturers to such devices.

Recent studies report that parents and caregivers often give children incorrect doses of OTC liquid medications due to poorly marked packaging and because they often use household spoons, according to MedPage Today.

The change will take place in mid-2011 after a transition period during which the concentrated products may still appear on store shelves for a time.

Copyright 2011 ABC News Radio


Study: Too Much Acetaminophen May be Dangerous

Photo Courtesy - Getty Images(NEW YORK) -- Concerns are being raised about the pain-killing drug acetaminophen and the problems that can arise from its usage.

One study found that acetaminophen, which is sold over the counter in items such as Tylenol, was responsible for almost 500 deaths a year in the U.S. due to over-consumption.

Medical experts say problems arise when people take too much at once, or too much over a length of time. Some health problems that can arise when too much acetaminophen is consumed include liver toxicity, liver failure, and death. Medical experts say extra strength Tylenol contains five hundred milligrams of acetaminophen in each pill, and by taking eight pills per day a person will have ingested 4000 milligrams of the drug, enough to damage the liver.

In January the FDA ordered a limit to the amount of the drug that can be used in prescription narcotic pain relievers, however this does not impact over-the-counter drugs. Medical experts suggest moderate consumption of acetaminophen, and that people consult their physician about the drugs they take regularly to find out about any potential risks.

Copyright 2011 ABC News Radio


FDA to Restrict Acetaminophen Content in Prescription Drugs

Photo Courtesy - Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration Thursday asked drug manufacturers to limit the strength of acetaminophen, a drug commonly used in both prescription and over-the-counter medications, in their products.  Combination prescription medications will be allowed to include no more than 325 mg of acetaminophen in each tablet or capsule.

The FDA's decision to restrict the drug's content level comes from acetaminophen's risk of severe liver injury as well as its associated allergic reactions.

Additionally, manufacturers of products containing acetaminophen will now be required to include a boxed warning emphasizing the potential risk of liver toxicity and a warning listing the drug's potential allergic reactions such as swelling of the face, mouth and throat, difficulty breathing, itching or rash.

The agency highlights that the action will only affect prescription medications (e.g., Vicodin, Lortab).  Over-the-counter products used to reduce pain and fever (e.g., Tylenol) were not included in the FDA's decision.

Copyright 2011 ABC News Radio

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