FDA Endorses Flow Restrictors on Kids' Liquid Acetaminophen

Megan Brooks

August 12, 2015

In a "guidance to industry" document issued August 4, the US Food and Drug Administration (FDA) endorsed the use of flow restrictors for over-the-counter (OTC) pediatric oral liquid drug products containing acetaminophen.

"OTC pediatric oral liquid drug products containing acetaminophen have been associated with overdoses due to medication errors that resulted in serious adverse events, including severe liver damage and death, the FDA notes in the document. This guidance is designed to help "drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage" associated with use of these products.

Specifically, the FDA recommends adopting "container features designed to improve safety by potentially contributing to more accurate dosing and helping to reduce the incidence and magnitude of accidental acetaminophen ingestion by children, such as an appropriate flow restrictor contained in the opening of the immediate container."

"If a flow restrictor is included, it should be attached to the container in a way that prevents it from being pushed into the bottle or easily removed. Firms are encouraged to discuss innovative containers/packaging features with FDA before introduction into the market," the FDA says.

Flow-restrictors fit onto the top of a bottle to guard against children inadvertently squeezing or sucking out too much of the liquid medicine, the investigative news organization ProPublica notes on their website.

While the FDA guidance does not require use of the devices, "it is a strong signal to manufacturers that flow restrictors are considered an important safety feature to help reduce accidental overdoses," the organization notes.

"This is definitely significant," Daniel S. Budnitz, MD, MPH, from the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia, told ProPublica.

Each year in the United States, roughly 10,000 children are seen in emergency departments because of overdosing on liquid medicines, many of them containing acetaminophen, according to Consumer Reports .

The FDA guidance comes 20 months after ProPublica and Consumer Reports reported on the flow restrictors, which have been shown to reduce the liquid dose that children can accidentally remove from a bottle, ProPublica says.

In 2011, a month before an FDA panel was set to discuss the use of flow restrictors, pharmaceutical industry representatives announced that they would voluntarily begin adding flow restrictors to infants' and children's pediatric medicine bottles, led by McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol, ProPublica says.

Consumer Reports recently tested flow restrictors on more than 30 liquid infant acetaminophen bottles found on drugstore shelves. While all of them did make it harder for kids to consume the liquid, some devices worked better than others.

Efforts are under way by multiple partners to develop standards to test the efficacy of flow restrictors. Final results are expected to be issued in 2016 by the American Society for Testing and Materials (ASTM) International, according to ProPublica.

"Still, neither the drug agency nor industry has indicated a willingness to require the flow restrictors for other liquid children's medicines, such as prescription cough medicine. Researchers believe that installing the devices in all kids' liquid medicines might help further reduce accidental overdose," ProPublica says.

"It's incremental progress, but it definitely is progress," Dr Budnitz told the organization.


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