FDA Sends Out New Warnings About Baby Acetaminophen Dosages

An attempt by the Food and Drug Administration to reduce dosing confusion about liquid acetaminophen has led the agency to clarify a warning about dosing because the first changes created even more confusion.

Major manufacturers agreed in 2009 to produce acetaminophen in only one strength after FDA advisory committees raised concerns about confusion and dosing errors. The new standard concentration is 160 mg/5 mL.

Ideally, that would mean only one concentration of acetaminophen would be available. But because the change was only a voluntary one, some manufacturers opted not to comply with the single-concentration recommendation. As a result, multiple concentrations remain on store shelves including 80 mg/mL and 80 mg/0.8 mL. Adding to the confusion, manufacturers who changed the dosage did not always change the packaging to make it clear that the product is a different strength.

The FDA stressed that the new dosages come with an oral syringe to help with precise dosing. Older products came with droppers. Acetaminophen is still safe in other concentrations as long as parents continue to use the correct dose for the concentration. The FDA also urged healthcare professionals to instruct parents in proper dosing and to explain the problems associated with incorrect dosing when they recommend the drug for children.

Chicago medical malpractice attorney Paul Greenberg has experience in helping parents whose children have been given the wrong dosage by a medical professional. To learn more, call 877-595-HURT (4878) or visit more of https://briskmanandbriskman.com.


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