We’ve written frequently about how difficult it can be to give children proper dosages of medicine — “How Big Pharma and the Fed Caused Infant Death Over Confusing Acetaminophen Dosages” and “Cold Medicines Are Dangerous for Very Young Children,” for example. ProPublica.org, the investigative news site, recently discussed how a certain safety device on medicine for kids could prevent drug accidents and overdoses.
Now, as reported by that outfit, New York Sen. Charles E. Schumer is urging the FDA and the Consumer Product Safety Commission (CPSC) to require drug makers to install flow restrictors in all liquid children’s medication within a year.
“If they don’t do it on their own, I will seriously consider legislation,” he said at a news conference last week.
Flow restrictors, as described by ProPublica, are small, plastic valves inserted into the necks of bottles of liquid medicine to slow the release of medication. That makes it more difficult for children to swallow a harmful amount. Approximately 10,000 children are seen every year in emergency rooms for potential medication overdoses, according to the Centers for Disease Control and Prevention (CDC). Some are hospitalized, and about 20 kids die from overdoses.
In 2011, drug makers voluntarily placed flow restrictors in bottles of infant’s acetaminophen, the active ingredient in Tylenol. Many also put them in children’s acetaminophen products.
But acetaminophen, says ProPublica, is involved in only about 1 in 4 of those emergency room visits. Other common over-the-counter medicines, including ibuprofen, cough and cold formulations and antihistamines, account for most of the rest.
Although industry trade groups say they are studying ways to minimize these accidents, federal regulators haven’t exactly been aggressive in making the industry do more. For one thing, FDA officials hold differing opinions about whether they have the power to mandate the devices.
Last year, the CPSC promoted the establishment of a voluntary set of standards for flow restrictors, working with a nongovernmental organization composed of industry representatives, federal officials and independent researchers.
The companies that make acetaminophen products have installed flow restrictors of varying efficacy, according to ProPublica. Different models were tested, and so-called “closed” restrictors — resealing rubber coverings that must be punctured by a syringe — worked better than “open” designs, typically plastic discs with small holes at their centers. But of the 31 bottles tested, only five had closed restrictors.
Schumer wants all the meds to have the closed restrictors. In his news conference, he said, “The closed restrictor, the foolproof kind, is 8 to 10 cents a bottle. You’re paying five, six, seven dollars, even more for this medication, so another dime to keep your kids safe is a choice that just about every parent would make.”