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FDA Drug Safety Podcast for Healthcare Professionals: Addition of another concentration of liquid acetaminophen marketed for infants

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Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information I'm Steve Jackson, a pharmacist in the Division. Today's topic: Addition of another concentration of liquid acetaminophen marketed for infants.

On December 22, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at local stores. Until now, liquid acetaminophen marketed for infants was only available in 80 mg/0.8 mL or 80 mg/mL concentrations. This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.

In addition to this change in concentration, this product may also be packaged with an oral syringe instead of a dropper.

To avoid confusion and the potential for dosing errors, consumers, parents, and caregivers should carefully read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use. Do not depend on banners stating that it is a new product to identify different concentrations of liquid acetaminophen. Many products have similar banners.

It is also important to use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Patients and caregivers should contact their healthcare professional if they find the measuring device confusing or are unsure how to measure a dose for a child using the device provided.

Healthcare professionals should make sure to provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to a child.

FDA has prepared a list of questions and answers and has issued a Consumer Update to provide an additional overview of these changes to OTC liquid acetaminophen marketed for infants.

At this time FDA recommends that Healthcare Professionals be aware that:

  1. Another concentration (160 mg/5 ml) of liquid acetaminophen marketed for "infants" is now available in stores. This product is less concentrated than other liquid acetaminophen products marketed for infants. The other products currently available are in 80 mg/0.8 mL and 80 mg/1 mL concentrations.
  2. Clinical judgment should be used to recommend the most appropriate liquid acetaminophen product for children under the age of 12, and they should counsel caregivers on product differences.
  3. The 160 mg/5 mL acetaminophen marketed for infants may be packaged with an oral syringe instead of a dropper. It is important to use only the dosing device provided with the product. Do not mix and match dosing devices.
  4. The concentration of liquid acetaminophen should be included on a prescription because multiple products with different concentrations are available.
  5. Adverse events involving OTC infant acetaminophen products should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including additional background information and pictures, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.


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