SILVER SPRING, Md. -- For the first time since they came on the market in the 1950s, children's liquid medicines containing acetaminophen would carry dosing instructions for children younger than 2, if the FDA follows the unanimous recommendation of a federal panel.
The FDA's Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee voted 21-0 on Wednesday morning that children's oral single-ingredient acetaminophen products should carry instructions on how much to give to babies between the ages of 6 months and 2 years.
Currently, the labels of such products, including Tylenol or Triaminic, instruct parents to "consult a doctor" before giving the medicine to children younger than 24 months.
Despite that recommendation, however, parents still give their infants acetaminophen and products containing it, and in many cases, physicians suggest doing so to ease fever symptoms in babies.
Given that real-world situation, the advisory panel's new recommendation is a move to prevent acetaminophen overdoses in those younger than 2, which have increased in the past decade, said Scott Furness, PhD, director of the FDA's Division of Nonprescription Regulation Development.
Overdoses can occur when a parent or another caregiver is confused about the concentration of the medicine they're administering, when adult formulations are given to kids, when several products containing acetaminophen are combined, when a measuring cup is not clearly marked, or when a parent uses a household spoon or doesn't use a dosing device at all.
From 2002 to 2008 there were about 9,000 calls made each year to poison control centers where kids were given the too much acetaminophen according to a presentation by the FDA. About half of those calls involve a child younger than 2.
In four cases reported to the FDA's Adverse Event Reporting System, an infant died of severe liver damage after a parent gave the child too large dose of acetaminophen-containing medicine.
The joint panel also unanimously agreed that liquid medicines for children should prominently carry weight-based dosing charts, which panelists felt would be a more accurate dosing indicator than an age chart.
Weight-based dosing has been used many acetaminophen products since the 1980s, according to McNeil Consumer Healthcare, the company that makes Tylenol.
Overdosing isn't the only problem prompting the recommendation for weight-based dosing. Overweight children who are given doses intended for normal-weight kids may get too little of the drug to reduce the child's fever.
"The most accurate way of avoiding over/under dosing is to have weight-based schemes," said panelist Henry Farrar, MD, an Arkansas pediatrician.
Concern over acetaminophen misdosing has persisted for at least the past decade, and the FDA has held several advisory committees on the subject, but changes are just now beginning to happen.
In early May, the FDA issued a guidance for makers of OTC liquid medications, calling for every liquid drug sold over the counter to have a measuring device in order to prevent accidental overdose. Manufacturers of over-the-counter liquid medications have announced they would be adopting syringes with dose restrictors for products intended for infants, but that cups will continue to be provided for older children.
Wednesday's panel seemed to favor having all manufacturers use one standardized device -- possibly a syringe -- but mandating what device drugmakers package with their drug is out of the purview of the FDA. Some panelists said cups are too confusing -- with multiple measurement markings -- and contribute to overdose.
"Dosing cups just aren't a good device," said panelist Winifred Landis, RPh, a pharmacist in Lafayette, Ind. "They lead to so many errors."
A 2010 study found that parents giving children liquid medications often gave too much, especially when the dosing device was a cup instead of a spoon or oral syringe.
An earlier FDA panel favored nixing the various dosages of liquid acetaminophen products on the market and offering just one formulation. Over-the-counter drugmakers recently announced that liquid acetaminophen products for children under 12 will be sold only in a 160 mg/5 mL concentration.
The Consumer Healthcare Products Association (CHPA), the chief trade group for OTC drug manufacturers, also announced it would no longer produce acetaminophen in concentrated infant drops.
The FDA's review of OTC children's products found that between 1992 and 2000, the majority of inquiries received by McNeil -- the company that makes Tylenol -- were requests for dosing instructions for children under 2. Many of the inquiries were related to Infant Tylenol Drops.
The panel supported having just one dose of liquid medicine and voted 17-3, with one panelist abstaining, that the same should apply for pills, chewables, and meltaway tablets.
The panel also felt that drugmakers should stop advertising their products as painkillers for children under age 2.
Currently, many children's products are approved for reducing fever and reducing pain. But there have never been trials in children that prove acetaminophen eases mild-to-moderate pain in that youngest population; that data has always been extrapolated from trials performed on adults.
"The analgesic property of acetaminophen in young children has not been shown," said panelist Ruth Parker, MD, professor of medicine and public health at Emory University School of Medicine in Atlanta.
The panel voted 16-5 that acetaminophen products should not make analgesic claims for children younger than 2, but it voted unanimously that the products' fever reducing claims are legitimate.