FDA warns parents on cough, cold medicines
Cites risks posed to young children
WASHINGTON -- Hoping to prevent a growing number of injuries to infants and toddlers, the Food and Drug Administration issued an advisory yesterday warning parents never to give cough and cold medicines to children under the age of 2 unless instructed to do so by a doctor.
The warning is part of a broad reassessment by the agency on the safety of the popular medicines, which have been blamed for hundreds of injuries and a handful of deaths.
The FDA will convene a panel of independent experts 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 to children 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 FDA spokeswoman.
If, despite label warnings, parents continue to use the drugs inappropriately in young children, the agency could take more serious action, such as restricting availability. Most drugs that have been withdrawn in the past 15 years were taken off the market because doctors and patients failed to heed warnings.
Some of the drugs have drawings or pictures of infants in diapers on their labels.
The debate has arisen because the standards for drug approvals have changed sharply in the decades since many of the medicines in children's cough and cold products were approved. If those drugs were up for review, they would not be approved for use in children because the manufacturers never tested them thoroughly in children. Instead, the drugs' makers performed studies in adults and then assumed that they would work in children. Such assumptions, once common, are no longer acceptable. A growing number of studies in children suggest that cough and cold medicines work no better than placebos.
