Fewer kids went to U.S. emergency departments for reactions related to over-the-counter cough and cold medicine after manufacturers printed new warnings on medicine bottles, says a new government study.
But the researchers from the U.S. Centers for Disease Control and Prevention (CDC) say more can be done to prevent kids from accidentally taking cough and cold medicine.
“Progress has been made, but there is still a lot of work to do to reduce adverse events from cough and cold medications,” Dr. Lee Hampton, the study’s lead author, said. He’s a medical officer with the CDC in Atlanta.
After questions about the medicines’ effectiveness, reports of emergency department (ED) visits and even deaths among young children, drugmakers voluntarily recalled over-the-counter cough and cold medicines for children in October 2007.
The medicines were re-released the following year with stronger warnings that they should not be used among children younger than age four.
Although studies have reported drops in calls to poison control centers related to cough and cold medicine, surveys showed parents were still giving it to young children, write the researchers in Pediatrics.
For the new study, Hampton and his colleagues used information from a database that estimates the number of so-called adverse events reported in U.S. EDs.
Overall, there were about 61,168 ED visits between 2004 and 2011 among children younger than 12 years old for adverse events related to cough and cold medicines.
Before they were pulled from the shelves, the researchers found children under two years old who had a reaction to cough and cold medicines accounted for about 4 percent of all emergency visits for adverse events related to any drugs. After the medicines were put back on shelves, the number fell to about 2 percent.
Among two- and three-year-olds, reactions to cough and cold medicines represented about 10 percent of all ED visits for drug-related problems before the products were removed. That fell to about 7 percent after the medicines were put back in stores with new warnings.
Although the researchers focused on the labeling change, Hampton told Reuters Health the drop could be attributed to a few factors.
“It’s more complicated than that because there was a lot of media coverage around that labeling change in 2008,” he said. There were also educational campaigns launched to advertise the new labels.
Although fewer children in both age groups had a reaction after taking the medicines under adult supervision following the labeling change, the trends for unsupervised ingestion of cough and cold medicine were mixed.
The researchers found about 64 percent of children under two years old who ended up in the ED after taking the medicine had swallowed it while unsupervised. That was true both before and after the labeling change.
Cough and cold medicines accounted for a smaller proportion of emergency visits for unsupervised ingestions among children ages two and three in more recent years. Unsupervised use, however, still represented about 89 percent of ED visits for cough and cold medicine reactions in that age group after the labeling change.
“It’s not a labeling issue anymore,” Dr. Joshua Sharfstein said. “It’s that the bottles themselves could be made safer.”
Sharfstein, the secretary of the Maryland Department of Health and Mental Hygiene, was not involved with the new study. He was one of the first pediatricians to raise concerns over cough and cold medicine use among toddlers.
“I think the labeling is helpful, but more children can be protected,” he told Reuters Health. “I think looking at the design of the bottles is a smart thing to do.”
Hampton and his colleagues write that possible design changes to cough and cold medicine bottles could include flow restrictors, which would limit a child’s ability to get access to the syrup.
They also write that safer medication handling and storage practices could help.
“The three main things is first don’t give cough and cold medications to children less than four years old, keep medications up and out of sight and properly lock the caps on medication bottles,” Hampton said.
In a statement to Reuters Health, Barbara Kochanowski, vice president of regulatory and scientific affairs for the Consumer Healthcare Products Association (CHPA), said the study shows what the organization knows to be true.
“Through proactive education, packaging and labeling improvements, and continued research, manufacturers are helping parents choose the right medicine, use the right medicine, and store medicine appropriately to avoid accidental, unsupervised ingestion – the primary cause of the few reported adverse events involving these medicines,” she said.
The CHPA is a trade organization representing manufacturers of over-the-counter medicines and dietary supplements.
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