Stanching the Flow of a Dangerous Drug for Kids

For years it’s been known that acetaminophen, the active ingredient in Tylenol, poses risks of overdose, particularly in children. Finally, the FDA has endorsed using a safety device to restrict the drug’s flow from bottles of the children’s medicine to prevent them from accidentally getting too much liquid.

As explained by, the feds took action nearly two years after ProPublica and Consumer Reports explained how a flow restrictor could prevent the overdoses that can cause liver damage and, in some cases, death.

Every year, about 10,000 children visit an emergency department after overdosing on liquid medicines, many of them containing acetaminophen, a common pain reliever. Many people want to put flow restrictors on all liquid medicines used by children, not just those containing acetaminophen, but that’s been a nonstarter for the authorities and the industry, even though ProPublica found internal FDA documents showing that the agency’s own scientists had lobbied for the adoption of restrictors since at least 2001. The FDA waffled, unsure if it had the authority to require their use.

In 2011, a panel of outside advisors to the FDA was supposed to discuss the use of flow restrictors and other measures, but a month before the meeting, pharmaceutical industry representatives announced that they would start adding the devices to infants’ and children’s pediatric medicine bottles as a voluntary measure.

Companies offered several kinds of devices, and Consumer Reports tested them.

After the reports were published, government regulators and industry reps worked to develop standards to test the efficacy of flow restrictors. Final results are expected to be issued in 2016 by ASTM International, which sets guidelines for more than 12,000 products and services.

“The FDA’s formal guidance,” according to ProPublica, “has the effect of pushing makers to use flow restrictors on acetaminophen products for kids. And the standards will provide makers with a uniform way to gauge the performance of the devices.”

Still, nobody – not the government, not the drug industry – seems willing to require the flow restrictors for other products that can be hazardous to children, such as prescription cough medicine.

Why not?

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