Schumer wants safety devices added to children’s medicines

by Theodoric Meyer and T. Christian Miller ProPublica, Jan. 20, 2014, 9 a.m.

Sen. Charles E. Schumer is calling on federal regulators to require that all liquid children’s medications be equipped with safety devices called flow restrictors, following an investigation by ProPublica and testing by Consumer Reports showing that the devices can help prevent accidental overdoses.

Flow restrictors are small plastic valves that fit into the necks of bottles of liquid medicine, slowing the release of medication and making it harder for children to swallow a harmful amount. Each year, about 10,000 children visit the emergency room for potential medication overdoses, according to data from the Centers for Disease Control and Prevention. Many suffer no lasting harm, but some are hospitalized. About 20 kids die each year from overdoses, federal data shows.

Schumer, a New York Democrat, cited ProPublica’s reporting on Sunday in urging the U.S. Food and Drug Administration and the Consumer Product Safety Commission to study the issue and move 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,” Schumer said at a press conference in New York.

Following a voluntary industry pact in 2011, drug makers placed flow restrictors in bottles of infant’s acetaminophen, the active ingredient in Tylenol. Many also placed the safety valves in children’s acetaminophen products. (ProPublica published an in-depth investigation of acetaminophen’s risks in September.)

But acetaminophen is only involved in about a quarter of the 10,000 annual emergency room visits. Common over-the-counter medicines, such as ibuprofen, cough and cold formulations and antihistamines, account for the majority of the remaining trips. The Consumer Healthcare Products Association, an industry trade group, said it is studying whether to install the devices in other medications.

“Our member companies are committed to efforts to reduce medication errors,” said Elizabeth Funderburk, a spokeswoman for the group. She added that caregivers can reduce the chances of an accidental overdose by properly locking child-resistant caps and storing medicines out of the reach of children.

Federal regulators have done little to press the industry to do more. In 2010, FDA Commissioner Margaret Hamburg made a direct appeal to drug makers to explore the use of flow restrictors. But agency officials have offered differing opinions about whether they have the power to mandate the devices. FDA officials did not return a request for comment on Sunday.

Last year, the CPSC began a process to promulgate a voluntary set of standards for flow restrictors, working with a non-governmental organization comprised of industry representatives, federal officials and independent researchers.

The commission “shares Sen. Schumer’s belief that preventing child poisonings from household medicines is a vital product safety issue,” said Scott Wolfson, a commission spokesman. The standards setting process “is moving in a positive direction.”

In the absence of federal guidance, companies that make acetaminophen products have installed flow restrictors of varying efficacy. Consumer Reports tested various models and found that so-called “closed” restrictors

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