After hundreds of serious injuries and a handful deaths, the FDA warns parents not to give cough medicine to children under 2 years old.
The F.D.A. will convene a panel of independent experts on Oct. 18 to discuss whether more prohibitions or warnings are warranted. Such meetings often signal that the agency is seriously concerned about the safety of the drugs under review.
The drugs’ labels currently advise parents to see a doctor before giving the medicines if their child is under the age of 2, but too many parents are failing to heed this advice, the agency said.
“We continue to see adverse effects associated with the medicines because people are not using them properly,” said Susan Cruzan, an F.D.A. spokeswoman.
If, despite label warnings, parents continue to use the drugs inappropriately in young children, the agency could take more serious action, like restricting the drugs’ wide availability.Most drugs that have been withdrawn in the past 15 years were taken off the market because doctors and patients failed to heed prominent warnings.
The Times reports that some labels have pictures of toddlers in diapers on them, even though these medications were never throughly tested on children. And “a growing number of studies in children suggest that cough and cold medicines work no better than placebos.”