With the majority of parents working and children being placed in daycare centers as early as 4-weeks-old, exposure to the common cold begins very early. First-ever study results provides evidence on the dangerous use of OTC cold meds in young children.
Early the year, the U.S. Food and Drug Administration
issued an advisory against the use of over-the-counter cold medicines on children under the age of two, stating that
"there are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness."
"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."
This advisory came
three months after drug companies issued the same warning and pharmacies began pulling the products from their shelves to prevent temptation. The recall was voluntary.
According to the report:
“The advisory committee declared the products were ineffective in younger children, but we were not able to identify a single adequately designed study that compared the efficacy of these products in older and younger children,” Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Thus the product’s efficacy remains unproven in all children under the age of 12.
“The companies have known for decades that their products are unproven, yet they have continued to foist them on concerned parents who believe that the FDA protects them and their children from ineffective medications,” said Lurie.
“Simply because these drugs are well-tolerated by many children is not an adequate rationale for allowing them on the market. The law is clear that ineffective medications are not to be sold, no matter how safe they appear to be,” he said.
In a
news report released today, a benchmarking study out of Emergency Medicine Network by Katherine O’Donnell, M.D. of Children’s Hospital Boston confirms the reports and reveals some interesting statistics related to those children under two.
Of the children under the age of two presenting with bronchiolitis, a condition that masks itself as the common cold but progresses more severe coughing and wheezing, the study found that one-third were given OTC cough and cold medications one week prior.
That is simply one hospital and one condition not indicated for cold medicines in the age group receiving the dangerous medication. It does not include the countless numbers who not take their children to the hospital and it does not include those who continue to ignore the warning.
According to O'Donnell, the need to continually monitor the use of the medications in the under two age group will remain, saying “After the recall and labeling changes, it will be important to monitor for potential ongoing use of these medicines in young children and observe if parents or physicians are turning to other therapies in place of these medications." She also encourages physicians to counsel parents of patients on the dangerous risk associated with these medications as well as their lack of efficacy on children under two.
As the medications continue to remain on pharmacy shelves, parents still have the opportunity to self-medicate their children despite the warning handed down by both drug manufacturers and the FDA.
High risk factors associated with the use of the potentially life-threatening medications were antibiotic use, daycare attendance, exposure to secondhand smoke and wheezing. The paper, entitled “Use of Cough and Cold Medications in Children Age