Early this year, the FDA issued a Public Health Advisory for parents and caregivers not to give their children below 2 years old OTC cough and cold drugs because of the serious and potentially life-threatening side effects of these medications. The advisory includes decongestants, expectorants, antihistamines and antitussives commonly used to treat colds.
Dr. Charles Ganley, director of FDA's Office of Nonprescription Products, explained the OTC medicines treat symptoms and not the cause of the ailment. Adverse effects of OTCs include death, convulsions, rapid heart beating and lower levels of consciousness.
According to data from Nielsen Company, a market research firm, American families spend at least $286 million a year on OTC cold medicine for children. Such medications are given to 10 percent of all children in the U.S. on any given week, a Boston University report said.
Dr. Joshua Sharfstein, health commissioner of Baltimore, said there is little evidence to show that OTC medication for cold are effective for young children. Sharfstein added, quoted by the Chicago Tribune, "There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6."
The FDA has scheduled a public hearing on the proposed OTC recall on Thursday.
