Children’s, Infant’s Acetaminophen To Be Standardized

Existing formulations of <"">liquid acetaminophen for infants are being removed from shelves and will be replaced the same drug concentration as the current version for children, said The LA Times, citing over-the-counter (OTC) drugs makers.

The change will occur mid-year, said Consumer Healthcare Products Association (CHPA), a group that represent nearly all brand name and generic OTC drug makers.

Today, infant acetaminophen is provided in two strengths: 80 mg/0.8mL and 80 mg/1 mL. Going forward, acetaminophen will only be offered in the strength sold for children ages 2 to 12: 160 mg/5 mL, said The LA Times. Packaging will still include dosing cups; however, infant versions will have flow limit restricting syringes. The LA Times noted that a number of infant medications, such as Infant Tylenol, come with a dropper in current versions.

“CHPA member companies are voluntarily making this conversion to one concentration to help make it easier for parents and caregivers to appropriately use single-ingredient liquid acetaminophen,” CHPA President and CEO Scott Melville said in a press release Wednesday, quoted The LA Times.

In a related announcement, the U.S. Food and Drug Administration (FDA) discussed how dosing tools packaged with liquid OTC medications should be labeled to match dosing medications saying, “The FDA issued the guidance because of ongoing concerns about the potential accidental drug overdoses that can result from the use of dosage delivery devices with markings that are confusing, unclear, or inconsistent with the labeled dosage directions,” quoted The LA Times.

The change in labeling followed a study released late last year in which researchers revealed that of 148 OTC children’s products sold with measuring devices, most—146—were delivered with inconsistencies, for instance, unneeded markings on those devices, said The LA Times. Meanwhile, we just wrote that following an unprecedented 22 product recalls, drug and medical device giant Johnson & Johnson announced its plans to introduce new packaging for some of its medications. According to The Wall Street Journal, packaging will be revised for OTC children’s medications to help ensure dosing accuracy. The move is a long time coming and follows a rash of Children’s Tylenol and other drug recalls that have left consumers uneasy about purchasing Johnson & Johnson products.

The cap change will enable parents and caretakers to insert a syringe into the top of the medicine bottle, obtaining the correct drug dose, said William Weldon, Johnson & Johnson’s CEO, speaking in an interview with the Health Blog. “We want to take safety to a new level,” he said, quoted the Journal. The so-called “flow restrictor,” or dose-limiting cap is scheduled to be introduced as a number of medications such as Tylenol and Motrin, are reintroduced to the market following recalls for quality issues, said the Journal. Weldon said the changes will be rolled out from the end of 2011 through the beginning of 2012, wrote the Journal.

Other proposals have not been accepted by Johnson & Johnson. For instance, limiting the variety of children’s liquid medication to ease dosing; Johnson & Johnson claims it can make amendments to its packaging, such as the flow restrictor, noted the Journal.

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