In response to growing doubts about the safety and effectiveness of over-the-counter cough and cold medicines, the pharmaceutical industry conceded Tuesday that children younger than 4 should not take such drugs.
The voluntary changes came less than a week after federal health officials said they saw little evidence that the drugs work and some evidence that they can be dangerous. They did not, however, order the products off store shelves, for fear that parents would give their children adult medicines instead.
It's the latest chapter in a two-year tug of war between the pharmaceutical industry and pediatricians about over-the-counter medications that are in an estimated 39 percent of American homes.
Many pediatricians say home remedies such as honey and chicken soup are just as effective as commercial products. Meanwhile, for parents facing a winter of stuffed-up, sneezy kids who can't sleep, here's a backgrounder on the week's developments:
What happened Tuesday?
The Consumer Healthcare Products Association, which represents drug companies that make dozens of products marketed to children, intends to tell parents not to give them to any child under the age of 4. The association will also add a warning telling parents not to give children antihistamines to make them sleepy. Antihistamines are allergy-relief medications often found in medicines that combine several ingredients to treat a variety of symptoms.
At the urging of national pediatrician groups, the Food and Drug Administration last week held hearings on whether the cold medications should be banned for use by all children under age 6. The FDA has already banned their use for kids under the age of 2. The FDA, however, said that for older children, the issue needs further review. Leaving parents with no options for sick kids might cause parents to give their children medications intended for adults or unregulated herbal remedies, the FDA said. Pediatricians welcomed the shift by the industry.
So what's the problem?
Commercial cold medications have been around for decades, but there has been little research on their effectiveness, especially for children. Many doctors say non-medical remedies such as honey, humidifiers and chicken soup are just as effective. The industry says the medications are safe if used as directed. But misuse of cough and cold medicines sends about 7,000 children to hospital emergency rooms each year, with symptoms ranging from hives to drowsiness to unsteady walking. Many kids overdose by taking medicines when their parents aren't looking. In addition, parents sometimes accidentally give their children too much of a medication when they use more than one at a time without realizing that they contain the same ingredients. Doctors say that because a majority of the problems involve 2- to 3-year-olds, the industry's new instructions, if followed by parents, should help.
Pediatrician groups still support recalling the medicines for children under 6, and the FDA is studying their effectiveness for children under 12. But it could take a year or more for federal health officials to reach a final decision. The industry is also expanding an educational campaign aimed at getting parents to be more careful when giving their children cough and cold medicines.
The Associated Press contributed to this report. Josephine Marcotty 612-673-7394