December 27, 2011
FDA Warns Parents Of Confusing Acetaminophen Doses
The Federal Drug Administration (FDA) is asking parents and caregivers to double check the label on liquid acetaminophen before giving it to a child or infant.
The FDA asked guardians to be careful when reading the label on liquid acetaminophen marketed to infants and children as a new, less concentrated form of the popular pain reliever arrives on store shelves.
A new 160 milligram per 5 milliliter concentration of acetaminophen is now available in drugstores, which is a more concentrated version than the original 80 milligram per 1 milliliter version that may still be in people's cabinets.
"There is still some on store shelves; there is still some in homes; and there is still some in distribution," Carol Holquist, director of the FDA's Division of Medical Error Prevention and Analysis, said in a press release. "Be very careful when you're giving your infant acetaminophen."
Liquid acetaminophen marketed for infants use to be available only in stronger 80 milligram per 1 milliliter or 80 milligram per 0.8 milliliter concentrations. The less concentrated 160 milligram per 5 milliliter version was marketed for children.
A report from the FDA showed earlier this year that by different concentrations of the liquid acetaminophen for infants and children was leading to overdoses that made infants sick, while some died from liver failure.
Some manufacturers voluntarily changed the concentration of liquid acetaminophen for infants to the same concentration as the liquid acetaminophen in order to avoid these errors.
The new, less concentrated 160 milligram per 5 milliliter liquid acetaminophen for infants has new dosing instructions and may have a new dosing device in the box.
The FDA advises parents and caregivers to read the "Active ingredient" section of the Drugs Facts label on liquid acetaminophen marketed to infants or children in order to tell the difference between the products.
FDA officials said it´s important to note that there is no dosing amount specific for children younger than 2 years of age because those parents should check with a health care provider for dosing instructions.
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