The US Food and Drug Administration (FDA) has announced it is calling a meeting of its Nonprescription Drugs Advisory Committee next month to review the safety and effectiveness of medicines used to treat coughs and colds in children following recent concerns about their use, especially in infants below two years of age.

Part of the review will cover reports of medical problems arising from incorrect use of cough and cold drugs for children, especially overdoses. For example, in some cases parents have not realized that different products may contain the same active ingredient and giving a child both at the same time results in a combined dosage that exceeds the safety level.

The debate has arisen because standards for drug approval have tightened in the last few decades and some children’s medicines were approved when standards were not so tight as they are now. According to the New York Times, in some cases the drugs were only tested on adults and it was assumed they would be safe for children.

“If those drugs were currently up for review, they would not be approved for use in children because the manufacturers never tested them thoroughly in children,” says the report in the New York Times.

Some of the drugs have packages showing pictures of babies in diapers.

The FDA has issued a Public Health Advisory to remind parents about the dangers of giving a child too much medicine. Parents should read the “Drug Facts” section of the package label carefully, said the agency.

And parents should also know:

  • Children get better with time, and cough and cold medicines only treat symptoms like runny noses, congestion, aches and fever, they don’t cure colds.
  • Giving children, especially those under 2, too much medicine can lead to serious life-threatening side effects.
  • Never give cough and cold medicines to children under 2 unless a doctor has specifically directed it.
  • Never give children cough and cold remedies packaged for adults; only give those indicated specifically for babies, infants, children or “pediatric” use.
  • Cough and cold medicines come in different strengths and parents should always check with their healthcare provider if they are not sure of the right strength or dose for their child.
  • When more than one drug is being given to a child, parents should check their health provider knows this and the health provider should review the combined use and check for overdose danger, among other risks.
  • The “Drug Facts” section of the drug package or label should be read thoroughly before giving the medicine to children; check active ingredients and warnings especially.
  • Never give a child more than the dose recommended in the “Drug Facts” box. Dose is the amount given at one go times the frequency, so if it says twice a day don’t give it to them three times a day, no matter how bad the symptoms, go back to the doctor if the symptoms don’t subside.
  • To get the dose right, use an accurate measuring device, such as the dropper, dosing cup or measuring spoon that comes in the package with the drug. Do not use a kitchen spoon.
  • If the package does not include a measuring device then buy one from the pharmacy and make sure it is the right size for the dose advised in the “Drug Facts” box of the medicine package label or by the doctor.
  • Never ignore the “Drug Facts” advice, and consult the doctor if the information is not clear, especially about how to give the right dose or how to use the measuring device.
  • If a child’s illness gets worse or does not improve, stop the medicine and take them to the doctor immediately.

Some doctors say that no drug for use with younger children, especially those under two years of age, should be available over the counter.

Click here for FDA Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children

Click here for New York Times article Parents Are Warned on Cold Medicines.

Written by: Catharine Paddock