PEDIATRIC NEWS UPDATES OCTOBER 2007

Submitted by admin on Sun, 07/03/2011 - 03:27

Infant Cold Remedies Pulled off the Market

All four types of cough and cold medications are NO LONGER APPROVED for kids younger than 2 years of age.
All bottles of cold and cough meds that have dosing labels for kids under 2 have been taken off the shelves and are no longer available. The reason for this is two-fold: First, there have been a number of infants and young children harmed by accidental overdoses of these meds when a parent mixed different meds together OR gave too high a dose, this is the reason that the FDA decided to step in and make them no longer available. Second, there has been very little research done on young kids to prove that cold and cough meds are safe and/or effective. Even though they seem to work well and rarely cause any problems when dosed properly, the FDA felt it was prudent to put a hold on their use until further safety and efficacy data become available. And we agree.

What can parents do in the meantime to relieve cough and congestion when their young kids catch a cold or flu?
We suggest you try a natural alternative called SINUPRET. This plant-based pharmaceutical grade natural cold and cough medicine has been used in Europe for decades as a primary treatment for kids of all ages, and it just became available in the U.S. Not only does it relieve nasal and chest congestion and help clear out mucus, it also boosts the body’s own immune response to infections to help clear them out faster. It comes as a liquid or capsules. For more information visit www.bionoricausa.com/. Click here to find a retailer in your area.

The Consumer Healthcare Products Association announced Thursday that manufacturers were voluntarily ending sales of over-the-counter oral cough and cold products aimed at infants. The list includes infant drops sold under the brand names Dimetapp, Pediacare, Robitussin, Triaminic, Little Colds, and versions of Tylenol that contain cough and cold ingredients.

The withdrawal includes medicines aimed at children under age 2, after the Food and Drug Administration and other health groups reported deaths linked to the remedies in recent years, primarily from unintentional overdoses.

This recall comes just a week before government officials were set to begin debating these medications. Physicians have been warning that cold and cough remedies may not be effective in young children, and occasionally cause unwanted side effects.

Dr. Sears' Comments:

Do parents need to worry?
No, these medications are generally considered safe when used properly at the correct doses. If you have kids under the age of 2 who have used or are using these medications, you don’t need to worry about it, but you should stop use for now. Most of the problems resulted from improper dosing by the caregivers. The Sears doctors have long understood the challenges of infant colds and have always been very explicit in helping our patients realize the importance of proper dosage and use. We trust that our detailed dosing charts in the Medicine Cabinet section of AskDrSears.com has helped parents administer the correct dosage.

Once again, these medications are not harmful when given in the proper doses.

Which medications are being pulled off the shelves?
The remedies in question are mainly the “infant drops” by the brand names mentioned above. These medications usually come with a dropper or syringe for dosing. Medications for older children usually come with a medicine cup – these are not involved in the recall. Here is a complete list of brand names:

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

If my baby gets a cold, what should I do?
With cold and flu season just around the corner, it is important to remember there are many other ways to help a young infant get through a cold:

  • Nasal saline and bulb suctioning
  • Staying well hydrated
  • Getting plenty of rest
  • Cool-mist humidifier in the bedroom

For more information on treating colds click here to read our Colds and Coughs article.