Over the counter (OTC) cough and cold medicines for infants under 2 years of age are being removed from the shelves of stores and drug retailers following a voluntary withdrawal by drug manufacturers ahead of an evaluation meeting by an advisory committee to the US Food and Drug Adminstration set to take place at the end of next week.

The announcement to the press was made yesterday in Washington DC by the Consumer Healthcare Products Association (CHPA) on behalf of leading makers of OTC cough and cold medicines.

The withdrawal does not apply to medicines for children aged 2 and over, and the announcement also points out that the withdrawal is being driven by potential misuse of the products, such as giving babies too big a dose, and not by concerns about inherent product safety.

President of CHPA, Dr Linda A Suydam said that the medicines were safe when used at the recommended dose:

“It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately.”

“The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority,” explained Suydam.

The drug companies are voluntarily withdrawing the following products:

  • Dimetapp Decongestant Plus Cough Infant Drops,
  • Dimetapp Decongestant Infant Drops,
  • Little Colds Decongestant Plus Cough,
  • Little Colds Multi-Symptom Cold Formula,
  • PEDIACARE Infant Drops Decongestant (containing pseudoephedrine),
  • PEDIACARE Infant Drops Decongestant & Cough (containing pseudoephedrine),
  • PEDIACARE Infant Dropper Decongestant (containing phenylephrine),
  • PEDIACARE Infant Dropper Long-Acting Cough,
  • Robitussin Infant Cough DM Drops,
  • Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough,
  • TYLENOL Concentrated Infants’ Drops Plus Cold, and
  • TYLENOL Concentrated Infants’ Drops Plus Cold & Cough.

Click here to see pictures of these products.

The product manufacturers and the CHPA have passed on recommendations to the FDA saying the label on these products should be changed to say “do not use” in children under 2 years of age. At the moment the labels say “ask a doctor” before using in children under 2 years of age.

These will be discussed by the panel meeting next week, together with other comments and proposals made by FDA reviewers themselves.

Suydam explained that the product manufacturers are withdrawing the products out of “an abundance of caution” and that:

“The vast majority of parents and caregivers safely use these medicines to help relieve their children’s symptoms.”

She emphasized that as with all medicines, it was important to read OTC medicine labels carefully, and only use them as directed. And always store them where children cannot reach them.

The CHPA has announced that it will be launching a major and prolonged national campaign, in partnership with practitioner organizations, to alert and educate parents, caregivers and healthcare providers about the safe use of OTC medicines for children.

An article in the Seattle Times questioned why the announcement was being made now, as the issue had been “brewing” since March, when Baltimore’s commissioner for health, Dr Joshua Sharfstein petitioned the FDA to look into the safety and effectiveness of cough and cold remedies for children aged 6 and under.

Pediatricians across America, and the American Academy of Pediatrics, also supported the move, arguing that such medicines “don’t work” in such young bodies, and that they present risks not just for infants but for preschoolers too, said the newspaper.

Sharfstein, a pediatrician himself, said that pediatricians are taught “these products don’t work and may not be safe”, and yet every parent gives them to their child, he told the paper.

There appears to be a reluctance to revert to messier, old fashioned, but potentially less risky methods, such as “suctioning out infants’ noses” or using nose drops made just of salt water, as suggested by Sharfstein.

One wonders if the education campaign that the CHPA is planning will show parents how to “suction out” their children’s noses as a potentially lower risk (and presumably lower cost) alternative to opening an attractively packaged and reassuringly labelled bottle of medicine and giving them a spoonful of a sweet tasting syrup?

Click here for information about this voluntary withdrawal, and “What Parents and Caregivers Need to Know: OTC Cough and Cold Medicines and Children” (CHPA).

Click here for the FDA’s “Public Health Advisory Nonprescription Cough and Cold Medicine Use in Children”, issued on August 15, 2007.

Click here for patient information on “Common Colds and Young Children” (American Academy of Pediatrics).

Written by: Catharine Paddock