Addition Of New Infant Acetaminophen Concentration, 160 Mg/5 ML, Says FDA

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pediatrics / Children's Health;  Pain / Anesthetics
Article Date: 26 Dec 2011 - 0:00 PST


The FDA (Food and Drug Administration) says it has added a new concentration of acetaminophen aimed at infants, which is now available at retail outlets. The 160 mg/5 mL concentration has been added to the existing 80 mg/0.8 mL or 80 mg/mL concentrations. People who are used to the existing liquid acetaminophen concentrations should take note, the Agency emphasized.

Instead of being packed with a dropper, it will include an oral syringe.

Caregivers, consumers and parents need to read the Drug Facts label on the packaging carefully in order to avoid potential dosing mistakes, the FDA explained. They should not just go on what is written on the banners (that state it is a new product) when identifying various liquid acetaminophen concentrations. Several products have banners which are quite similar.

The product has a dosing device, which needs to be used so that the liquid acetaminophen dosages can be measured accurately.

If you find the measuring device confusing, or you are not sure how to measure the dosage for a child, you should talk to a doctor or health care professional.

Doctors and other health care professionals need to ensure that proper directions are given to caregivers and patients regarding how much should be administered to a child.

There is a list of questions and answers provided by the FDA, as well as a Consumer Update on OTC liquid acetaminophen aimed at infants.

Information for Parents, Caregivers and Consumers

• For the right dosing concentrations, and how to use the medication, read the Drug Facts label on the package
• If what you read on the label is not the same as what your healthcare provider said or wrote, check with a health care professional before administering the drug
• The oral syringe that comes with the 160 mg/5 mL liquid acetaminophen aimed at infants should only be used to measure the drug and administer it. Dosing devices should not be mixed and matched
• If you are not sure how to measure the dose using the device provided for you with the product, or if you have any doubts and queries regarding the concentration of liquid acetaminophen, check with a health care professional
• Any side effects experienced when taking OTC acetaminophen products should be reported to the FDA MedWatch program.

Information for Healthcare Professionals

• The new 160 mg/5ml liquid acetaminophen aimed at infants, which is now available at retail outlets, is less concentrated than existing concentrations of 80 mg/0.8 mL and 80 mg/1 mL.
• You should use your clinical judgment when recommending the best liquid acetaminophen medication for children aged under 12 years. Make sure caregivers are told about the differences between products.
• The liquid acetimophen 160 mg/5 mL concentration, that is aimed at infants, may have an oral syringe instead of a dropper. Only the device supplied should be used when dosing the product. Dosing devices should not be mixed and matched.
• When writing a prescription, the liquid acetaminophen concentration should be specific, because several products have varying levels of concentration
• Health care professional should also report medication errors and adverse events to FDA MedWatch program.

A recommendation was made in 2009, after a meeting involving the FDA Drug Safety and Risk Management Advisory Committee, the Anesthetic and Life Support Drugs Advisory Committee , and the Nonprescription Drugs Advisory Committee, that there should only be one OTC pediatric liquid acetaminophen concentration, thus preventing potential dosing confusion caused by different concentrations among caregivers and parents.

Some manufacturers decided to change their 80 mg/0.8 mL or 80 mg/mL concentrations to just 160 mg/5 mL to prevent dosing errors. However, this was a voluntary move, and many of the 80 mg/0.8 mL or 80 mg/mL concentrations were still available at retail outlets. Earlier this year, the 160mg/5mL concentrations started.

• Available in the past:
  
  80 mg/0.8 mL (dropper)
  80 mg/mL (dropper)
• Available now:
  
  80 mg/0.8 mL (dropper)
  80 mg/mL (dropper)
  160 mg/5 mL (oral syringe)

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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