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.
Why now?
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.
