A majority of medicine cups accompanying children's over-the-counter medications are flawed and fail to match dosing instructions on the labels, said Rep. Steve Israel, who on Monday announced new legislation that would standardize dosing devices and simplify the instructions.
With a bag full of brand-name medications - a fraction of those affected - Israel said he's introducing legislation that would require the U.S. Food and Drug Administration to bolster safety, and thus make it easier to give medications to children.
Citing a statistic reported earlier this month in the Journal of the American Medical Association, Israel said 99 percent of medicine cups and dosing devices attached to children's medications are flawed. The cup may clearly mark teaspoons, but dosage instructions on the label may call for tablespoons, he said.
Also, printed instructions are so small and confusing they are difficult to understand, Israel said. "You have to be a NASA engineer with the eyesight of a hawk to read and understand the fine print," said Israel, who called for clear instructions in plain language to avoid potentially dangerous overdoses.
Israel said that as the nation's regulatory agency for drugs, the FDA is chartered to guard the health of people of all ages by requiring companies to provide clear dosing information and easy-to-use dosing devices - but "for 35 years the FDA has been inconsistent on medicine cup inconsistencies."
FDA officials could not be reached last night for comment.
Dr. Michael Grosso, senior vice president of medical affairs at Huntington Hospital and a practicing pediatrician, sees the dosing cup issue as just one aspect of several larger concerns.
"This is a two-part problem," Grosso said. "The first part is that most of the cold and cough medications have limited efficacy in children. The other problem is what Mr. Israel is alluding to, because we've known over a long period of time that parents have problems" with dosing.
Children's over-the-counter drugs have been plagued with problems for years. Earlier this year, many were recalled for contamination. In 2007, an FDA panel of outside experts cited seizures, hallucinations and heart-rate problems among children who received inappropriate dosages of cough and cold remedies.
Federal investigators estimate parents give children 4 billion doses of over-the-counter drugs annually. Israel told a news conference at Huntington Hospital that dosing problems are exacerbated by dosing devices themselves: One-fourth, he said, lack necessary markings, and 80 percent have extraneous dosage markings that have nothing to do with administering the medication. Both can cause medication errors.
Northport mother Kirsten Rasmussen said she has had fears of giving too much medication to her son Jesse, 3, because of dosing cup problems. "I don't think, technically, I overdosed him," she said, and also highlighted differences between dosing devices and instructions.