As kids' accidental ODs rise, FDA still won't mandate flow restrictors in medicine bottles


In America, more under-6 kids go to the emergency room from accidental overdose than from car-accidents — they get hold of medicine and drink the whole bottle. Since 2007, epidemiologist Dr Daniel Budnitz has campaigned for the use of flow-restrictors in children's medicine bottles, which dramatically reduce the likelihood of an OD; manufacturers started adding restrictors to acetaminophen in 2011, but stopped there.

Flow restrictors have not been added to bottles of antihistamines, ibuprofen, and cough and cold preparations — even where they contain the same concentration of acetaminophen as plain acetaminophen tinctures. These other medicines account for about half of all overdoses by small children.

In a long, investigative piece, Pro Publica and Consumer Reports exhaustively document the effectiveness of restrictors, the intransigence of bottom-line-focused pharmaceutical manufacturers, and the real risks of children's medicine overdoses.

An FDA mandate would solve the problem of liquid overdose at the stroke of a pen, but the FDA refuses, preferring a voluntary approach that is demonstrably not working — and putting kids at risk. The incidence of overdose in small children is not only widespread — it's rising. Flow-restrictors are cheap, effective low-hanging fruit. Restrictors were invented to improve dosing and reduce spills in adult medicine, and are thus of benefit to everyone, not just parents.

Budnitz's analysis showed that in 2011 about 15,000 of the 74,000 children who went to the emergency room after a drug accident were admitted for further evaluation or treatment.

The poison control center data showed that of 450,000 children evaluated, more than 25,000 exhibited symptoms ranging from a faster heart rate to brief seizures to liver damage, a life-threatening condition.

Even in cases in which children suffer no ill effects, pediatric drug accidents have other costs, from the anxiety experienced by panicked parents to the expense of unnecessary trips to the ER, medical experts said.

The Fix Isn't In: Why a Safety Device That Can Stop Overdoses by Kids Isn't Widely Used