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FDA Endorses Safety Device for Kids’ Liquid Acetaminophen


August 13, 2015 — The FDA has endorsed flow-restrictors on pediatric liquid medicines containing acetaminophen to help prevent accidental overdoses.

Studies have estimated that 10,000 kids are taken to the emergency room after overdosing on liquid medicines every year. Liquid medicines for cough, cold, fever, and pain often contain acetaminophen. Even small overdoses can cause liver damage.

Flow-restrictors are inexpensive, simple devices that fit on the top of the bottle and limit the amount of medicine a child can squeeze or suck out of the bottle. Experts have been recommending industry-wide adoption of the devices since at least 2001, according to ProPublica.

Consumer Reports also recommended flow-restrictors on liquid medicines for adults back in 2013.

The FDA recommends flow-restrictors but drug-makers are not required to use them. McNeil Consumer Healthcare, a unit of Johnson & Johnson, already uses flow-restrictors on Infants’ and Children’s Tylenol. They are considering adding the devices on Benadryl, Sudafed PE, and Motrin.

About 200 lawsuits involving liver damage from Tylenol overdoses are now pending against McNeil in federal court in Pennsylvania. The lawsuits have been centralized in a Multi-District Litigation (MDL No. 2436 since April 2013.

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