The Food and Drug Administration began looking to ban the use of cough medicine for children 4 years old and younger last month based in part off of a Boston University professor’s survey.
BU epidemiology assistant professor Louis Vernacchio’s study found that at least 10.1 percent of U.S. children are administered cold and cough medicine at least once a week, and a large percentage of these children were 5 years old or younger ‘-‘- results found through surveys conducted in Boston.
Vernacchio conducted the study primarily between 1998 and 2007. He included over-the-counter drugs as well as prescriptions, vitamins and supplements. Pediatrics: the Official Journal of the American Academy of Pediatrics published the study in August.
Though the research targeted only medication usage, without tracking side effects, the study should be important to the medical community’s new examination of children’s medicine, Vernacchio said. He said he thinks the FDA is aware of the study, and that it gives a lot of important information to the medical community.
‘I think that our research answers questions about cough medicine, and gives an understanding as to which children are taking those medicines,’ he said.
The FDA is in the process of changing the pediatric cough medicines’ monograph, which lists key ingredients in a medicine, as well as dosage amounts and other regulations, FDA spokeswoman Rita Chappelle said.
Changing a monograph is a messy process that could take years to change, however. The FDA will begin drafting a new monograph for pediatric cough medicine and is open to receiving all kinds of data’ for the new regulations, Chapelle said. In the meantime, the FDA has strongly encouraged drug companies to voluntarily change many of their standards to prevent overdose in children, she said.
The risks of cold medicine outweigh the temporary relief, especially for children who are under school age. A normal, healthy 5-year-old child living in Boston will get an average of eight to 10 colds per year and, unless there is a fever or a high risk for a bacterial infection, there is no better medicine than ‘rest, plenty of fluids and lots of Kleenex,’ Sege said.
‘I never prescribe cold medicine to my own patients, and I never give them to my own kids.’
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