U.S. Representative Steve Israel announced legislation to direct the Food and Drug Administration to require drug makers to include safer and more accurate dosing devices, commonly known as flow restrictors, with their over-the-counter children’s liquid medication.
The congressman was joined in his remarks by Minu George, MD and Andrea Mokeski, MPH, a Port Washington resident and mother of two.
Speaking at a press conference at Cohen Children’s Medical Center on June 30, the congressman reviewed some sobering statistics.
“Data reported by the CDC shows that since 2011, about 74,000 kids per year were rushed to emergency departments after taking potentially toxic doses of medication,” he said. “Of that number, 1 in 5 needed to be hospitalized for further evaluation; about 20 kids die each year from such accidents.”
According to the congressman, including flow restrictors on over-the-counter children’s liquid medication “costs mere pennies to drug makers and helps keep our children safe by ensuring that they are getting the proper does of medicine.”
Flow restrictors are used voluntarily by the drug industry in infants’ and children’s acetaminophen (Tylenol) products. A syringe is inserted into a small opening (a self-sealing cap) and the exact amount of medicine required is withdrawn, rather than relying on a cup or a spoon that could lead to error. The device also slows the flow of medicine, making it more difficult for a child to ingest a dangerous amount. The FDA has indicated its support of flow restrictors, but they have not been required by law.
Dr. George, who introduced herself as “a mother and a doctor,” agreed with this demand.
“I’m very pleased to stand beside Congressman Israel in advocating for safer dispensers for children’s medications. When children are ill, parents are dealing with enough stress—they shouldn’t be concerned that they might be harming their precious children while trying to ease their pain. The flow restrictor would not only alleviate this concern, but further protect young children who face great peril, or even death, by overdosing on unsecured medication.”
The Protecting Our Kids’ Medicine Act would direct the FDA to require flow restrictors (or a safer tool if one becomes available) on all children’s liquid, over-the-counter medication and would also direct the FDA to require specifications to prevent the many dosing delivery device errors.
