I thought the parents on here might find this informative:



Cough and Cold Drugs Cause 7,100 ER Visits Yearly in Kids
By Michael Smith, North American Correspondent, MedPage Today
Published: January 28, 2008
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine. Earn CME/CE credit
for reading medical news


ATLANTA, Jan. 28 -- Cough and cold medications given to children account for nearly 7,100 visits to emergency departments every year for adverse reactions, the CDC has estimated.Action Points
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Explain to interested patients that the FDA has said that over-the-counter cough and cold medications should not be used in children under the age of two and that the industry has voluntarily withdrawn such medications.


Note that this study suggests that most cases of adverse events to the drugs that wind up in emergency rooms are the result of kids getting into the medications without adult supervision.
In the latest chapter of the debate over pediatric cold and cough medications, Daniel Budnitz, M.D., and colleagues said that most of these ER visits involve "unsupervised ingestion" of the drugs and not even one in 10 is the result of a medication error.


The findings emerged from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance system, which includes 63 emergency departments around the country, Dr. Budnitz and colleagues reported online in Pediatrics.


From Jan. 1, 2004 through Dec. 31, 2005, the 63 emergency rooms recorded 301 cases in which children younger than 12 were treated for adverse events attributed to cough and cold medications, the researchers said.


On a nationwide basis, that would work out to 7,091 cases a year, they reported, with 4,674 attributed to unsupervised ingestion and 582 blamed on an overdose. By comparison, 116,366 emergency room visits were laid at the door of other medication types.


The rate of unsupervised ingestion was significantly higher than for other medications, at 69.5% versus 47%, respectively, Dr. Budnitz and colleagues said.


Most of the children involved (64%) were two to five years old, they found, and among that group, an estimated 3,495 emergency room visits -- or 77% -- were blamed on unsupervised ingestion.


The report was immediately hailed by Linda Suydam, president of the Consumer Healthcare Products Association, a trade association representing U.S. makers and distributors of OTC medicines.


The study, she said in a telephone press conference, "underscores the need to get to the root causes of adverse events" linked to cough and cold medications.


One of those causes, she said, is accidental ingestion by curious and mobile younger children ages two through five -- a finding that was "no surprise to us," Suydam said.


Over-the-counter cough and cold medications for children have been recently under fire.


The FDA's Nonprescription Drugs Committee and Pediatric Advisory Committee recommended that they not be used in children age less than two and also said -- though less strongly -- that they should not be used in kids less than six. (See: FDA Warns Parents about Giving OTC Cough and Cold Drugs to Little Kids)


Following that, the association voluntarily recalled over-the-counter cough and cold medications labeled for use in infants but also argued that they should remain available to older children.


The CDC's study suggested one effect of banning the over-the-counter medications might be that parents would substitute others -- including adult-strength drugs.


Suydam said it's important that parents realize that over-the-counter medications "need to be respected" -- used as directed and kept out of the hands of kids.


"We need to educate parents that these are real medications and need to be treated as real medications," she said.


Fitting the CDC study into the current debate is difficult, because the researchers did not distinguish between OTC and prescription medications, said Richard Dart, M.D., Ph.D., director of the Rocky Mountain Poison and Drug Center in Denver.


"This is a bit of a challenge if we're interested in OTC drugs," he said during the press conference.


He also noted that the study did not list the types of adverse events that were seen. "The study just says they went to the emergency department and that they had an event," he said. "It doesn't say what the event was or how severe it was."


However, Dr. Budnitz and colleagues said, 93% of the children were treated and released, although 23% needed gastric decontamination. Of the 31 cases that required admission or extended observation, 25 were from unsupervised ingestion and 21 involved children ages two through five.


Dr. Dart said the most important adverse event is death, which is rare. He said that earlier research -- reported to the FDA -- had found that "it really takes an overdose" to cause death.


"At a therapeutic dose, we did not find a single death," he said. "There are some tragic cases where much more was given."


The authors pointed out that "engineering innovations could be particularly helpful in addressing unsupervised ingestions, which is the most frequent cause of adverse events. These innovations could be applicable to other children's medications."




The study was supported by the CDC and the Department of Energy.

The researchers reported no conflicts.