In August the FDA issued a strong warning to parents about using cough syrup for babies that are under 2.
A final decision will be made next week, but U.S. Food and Drug Administration reviewers have recommended that over-the-counter cough and cold medicines that contain decongestants and antihistamines should come with new instructions saying they are not recommended for very young children.
FDA reviewers said reports submitted to the agency “suggest that the use of prescription and (over-the-counter) cough and cold medication in younger children, particularly in children less than 2 years of age, could result in fatal overdoses.”
The product labels “should include prominent language to describe the risk of overdose in children,” the FDA staff said in a summary posted on the agency’s Web site.
They also recommended dropping the statement on many over-the-counter cough and cold remedies urging parents to “consult a physician” about use of decongestants in children under 2 years of age and antihistamines in children under 6 years of age.
“We suggest that the revised wording state that dosing is not recommended in these age groups due to the lack of evidence of efficacy and safety concerns,” the FDA staff said.
The agency received 54 reports of deaths with decongestants and 69 with antihistamines from 1969 through 2006, reviewers said. Most were in children younger than 2. Overdose and “drug toxicity” were commonly reported in those cases.
The FDA should start with the fact that they make cough syrup sweet and yummy like candy. It is a medicine, kids shouldn’t want to drink it…Oh, and while your changing things – can you please ask them to remove the crummy red dye. Why does everything have to contain deep red dye?