Overdose of liquid acetaminophen in infants could have fatal effects, warns the U.S. Food and Drug Administration.
The FDA recently issued a report outlining the dangers of acetaminophen products geared at infants.
Concerns have been raised by the FDA as a new, less concentrated, liquid acetaminophen product has hit the market.
With both an older, much higher concentration of the drug and newer, less concentration of the drug available, there is potential for confusion about the appropriate dose.
“Be very careful when you’re giving your infant acetaminophen,” said Carol Holquist, director of the Division of Medical Error Prevention and Analysis, in the report.
The warning comes on the heels of a report filed by the Center for Drug Evaluation and Research in April, which found confusion over the varying concentrations of acetaminophen resulted in overdoses that caused serious illness in infants and in some cases death associated with acute liver failure.
“If a pediatrician prescribes a 5 milliliter dose of the less concentrated liquid acetaminophen, but the parents administer a 5 milliliter dose of the more concentrated liquid acetaminophen, the child can receive a potentially fatal overdose during the course of therapy,” Holquist explained in the report.
The FDA is advising parents to discuss with their pediatrician the appropriate concentration of medication before administering to their child and to read the Drug Facts label provided on the product package carefully.
The federal agency is also warning parents not to assume products displaying the word “new” are referring to the concentration level of acetaminophen.
The report stresses liquid acetaminophen products may not contain dosing instructions for children under 2 years of age and the importance of consulting a pediatrician before giving over-the-counter medication to an infant.
Liquid acetaminophen brands marketed for infants include Pedia Care Fever Reducer Pain Reliever, Little Fevers Infant Fever and Pain Reliever and Triaminic Infants’ Syrup Fever Reducer Pain Reliever.
Concerns of acetaminophen overdose are not exclusive to infants.
The FDA launched the Safe Use Initiative to educate consumers about the dangers of using too much of the medication.
The initiative warns consumers to avoid taking any over-the-counter acetaminophen if prescribed medication containing the drug, which increases the potential for overdose.
“Liver injury from acetaminophen overdose remains a serious public health problem despite ongoing regulatory and educational efforts over the past several years to improve the safe use of medicines that contain acetaminophen,” according to documents from the Safe Use Initiative.
The Safe Use Initiative also contains a list of recommendations for labeling prescription drugs containing acetaminophen in an effort to reduce the number of overdose incidents.
Some of the recommendations include spelling out the name of the drug instead of using abbreviations on the Active Ingredient list and including a Liver Warning on the label.
The initiative also recommends pharmacies use plain language on prescription bottles, making risks and dosing easier to understand.
However, the FDA has assured consumers acetaminophen is safe when used properly according to the label directions. |
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