Cough and Cold Medicines for Kids

As we approach the cold weather, you may see your kids sniffling more, having sore throats and stuffy noses.

Choosing the appropriate remedy from a wide variety of over-the-counter medications is an important choice for parents. Over the past year there has been a lot of communication about whether or not these products should be used to treat children. The rules for marketing many of these products were developed many years ago. These rules do not always require that the products be studied in children to show whether they work for children but instead allow conclusions from experience of their effectiveness in adults.

My Take is that we must now understand scientifically that children are not just little adults. Current scientific standards must be used to assure these medications are effective and safe for your children in the correct prescribed dose to treat your child’s cough and cold.

FDA has been gathering information on these products, and we have held two public meetings with stakeholders. Thus far, we have recommended that these products not be used in children under the age of two because of concerns about serious and potentially life-threatening side effects.

In the meantime, manufacturers are taking voluntary actions. Some have announced that they will change the labeling of these products to include the statement “do not use” in children under four years of age. Manufacturers are also introducing other ways to help better inform consumers and to prevent misuse – such as new child-resistant packaging and new measuring devices for use with these products.

One thing is for certain: we must not give children medication labeled only for adults. And, when deciding on the right doses for children we need to rely on modern scientific standards.

While the FDA works to gather data and revise the labeling of certain ingredients and dosing for cough and cold products for children, please consult with your doctor or pharmacist with your particular questions about the use of these medications for your child or grandchild.

Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs (FDA)

It’s Official! Feds Nix Cold and Cough Meds for Kids Under Six

After weeks of speculation, the Food and Drug Administration (FDA) took the additional step of recommending that cold and cough medicines used by parents for generations no longer be administered to children under six.

While the resolution of the FDA is "not binding," it will surely impact how such medications are marketed, displayed and used.

The recommendation applies to medications containing any of the following ingredients: decongestants, antitussives (against cough) and antiistamines.

Not only to the over-the-counter medicines for cough and colds apparently not work for kids, but there are documented incidents of the meds leading to death in the recipient kids (generally due to parental misuse).

In a separate action, the American Academy of Pediatrics recently backed a petition by pediatricians urging banning such medications from kids under six.

Source: FDA


List of Withdrawn Pediatric Cold Medicines

The following medicines are among those that have been withdrawn from the market by their manufacturers for treatment of coughs and colds in infants. If you have any of these medicines at home, it would be wise to discard them to avoid accidental administration.

If you wish to use any of these medications for children between the ages of 2 -6, please contact your pediatrician for additional information. Be advised that their use in the 2-6 age group, while not covered by the current voluntary withdrawal, remains controversial.

Manufactured by Johnson & Johnson:

  • Concentrated Infants’ Tylenol Drops Plus Cold
  • Concentrated Infants’ Tylenol Drops Plus Cold & Cough
  • Pediacare Infant Drops Decongestant (PSE)
  • Pediacare Infant Drops Decongestant & Cough (PSE)
  • Pediacare Infant Dropper Decongestant (PE)
  • Pediacare Infant Dropper Long-Acting Cough
  • Pediacare Infant Dropper Decongestant & Cough (PE)

Manufactured by Novartis:

  • Triaminic Infant & Toddler Thin Strips Decongestant
  • Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough

Manufactured by Prestige Brands Holding

  • Little Colds Decongestant Plus Cough
  • Little Colds Multi-Symptom Cold Formula

Manufactured by Wyeth Labs

  • Dimetapp Decongestant Infant Drops
  • Dimetapp Decongestant Plus Cough Infant Drops
  • Robitussin Infant Cough DM Drops

Source: FDA

Baby Cold Medicines Withdrawn

In a voluntary drug withdrawal initiated by the FDA, major manufacturers of over-the-counter cold and cough medicine targeted to infants have withdrawn their products.

The stated reason was to avoid misuse by misinformed parents. The withdrawal only affects products for infants, leaving products for use in children 2 and older on the market.

Further research, and further negotiations between pharmaceutical companies and the FDA will decide the fate of cold medicines marketed to the 2 – 6 year old population.

In the New York Times, Dr. Daniel Fratarelli, a pediatrician on the American Academy of Pediatric’s committee on drugs stated in regard to pediatric cough and cold medicines, "I don’t recommend their use in any child… These medicines don’t help, they may hurt, so don’t use them."

Taking Zinc for colds? Think Again

In a paper by Stanford University Department of Pediatrics and Medicine, with the University of Virginia School of Medicine, and published in the Journal of Clinical Infectious Diseases, 105 published reports of zinc efficacy in warding off the common cold were studied.

Of the 105 articles reviewed, fourteen were randomized placebo-controlled studies—in other words, proper scientific studies. Of these fourteen studies, eleven featured the qualities of inquiry representative of a proper clinical trial.

In reviewing these eleven trials, the author’s concluded "this structured review suggests that the therapeutic effectiveness of zinc lozenges has yet to be established. One well-designed study did report a positive effect of zinc nasal gel."