FDA Looking at Acetaminophen Dosing for Infants

The U.S. Food and Drug Administration (FDA) is looking into adding dosing instructions on over the counter (OTC) children’s medications containing <"http://www.yourlawyer.com/topics/overview/Acetaminophen-Liver-Damage-Injury-Failure-Lawsuit-Lawyer">acetaminophen, said MedPageToday. Dosing instructions are not provided for this demographic—children under the age of two—which many believe is linked to the rise in acetaminophen overdosing in children.

Acetaminophen was introduced into liquid cold and cough medications in the 1950s with instructions to “consult a doctor” prior to administering to children under the age of two; MedPageToday cited medicines such as Tylenol and Triaminic. It seems, noted MedPageToday, that parents are apparently treating infants with medications containing acetaminophen to manage cold and flu symptoms, citing FDA data and the increase in hospitalizations for acetaminophen poisoning in very young children.

The FDA’s Nonprescription Drugs Advisory Committee and its Pediatric Advisory Committee Meeting—panels comprised of outside experts—are meeting today and tomorrow to vote on if new dosing labels will be included for children’s OTC cough and cold medications, said MedPageToday.

Meanwhile, we recently reported that existing formulations of liquid acetaminophen for infants will be removed from shelves and replaced with the same drug concentration as the current children’s version. 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 previously. Packaging will still include dosing cups; however, infant versions will have flow limit restricting syringes.

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. 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. 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.

The 2009 panel, which spoke with parents and physicians, learned that the key reason children were suffering from acetaminophen overdoses was due to their parents’ confusion on how to dose the medications, said Scott Furness, PhD, director of the FDA’s Division of Nonprescription Regulation Development, in a letter to advisory committee members, said MedPageToday.

In 2009, 38,500 patients were hospitalized for acetaminophen poisoning; infants up to one year of age made up one percent and children from two to six years of age made up two percent of all the reports, said MedPageToday, citing an FDA report.

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