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FDA Says No To OTC Cold Medications for Young Children

Posted by Jane Akre
Thursday, January 17, 2008 10:17 AM EST
Category: Major Medical, Protecting Your Family
Tags: Dangerous and Defective Products, FDA and Prescription Drugs

FDA issues a repeat health advisory against using cold medications for babies and toddlers under age 2.


The FDA is reissuing its public health advisory warning about over-the-counter (OTC) cold and cough medicines for babies and toddlers under the age of two.

Last October drug companies stopped selling to children under two because FDA advisers said the remedies didn’t work.

Johnson & Johnson (Tylenol Plus Cold) and Wyeth (Robitussin) announced they would voluntarily pull cold medications off the shelves.

Now the FDA is coming out with a tougher warning saying the non-prescription cold medications not only don't work they are too risky for children so young.

The FDA public health advisory warns parents “avoid cough and cold medicines because serious and potentially life-threatening side effects can occur."

Last October, the FDA reported it had 54 deaths reported in toddlers and babies linked to decongestants containing pseudoephedrine, phenylephrine and ephedrine.

And from 1969 to Sept. 13, 2006, the agency had 69 deaths reported with a link to antihistamines and ingredients diphenhydramine, brompheniramine and chlorpheniramine.

The Centers for Disease Control and Prevention reports that from 2004-2005, 1,519 children under two were treated in emergency rooms from an overdose of the cold medications. Overdosing can occur when parents give two different products with the same active ingredients or give too much of a dose too frequently.

The FDA feared that parents hadn’t stopped giving the drugs to young children if they had them around the house for older children.   

"We still have a concern," FDA’s Dr. Charles Ganley said. "It falls out of people's consciousness."

Joshua Sharfstein, Baltimore’s Health Commissioner first petitioned the FDA about the dangers of cough and cold meds for children under the age of six.  He says “It's a good first step.”

In May, his department forwarded to the FDA a medical examiner’s report of numerous incidents of death among youngsters who had taken cold medications. 

By next spring the agency should decide whether the OTC cold medications should be used for children under the age of 12. 

What should a parent do instead?  Sick children need to be hydrated so chicken soup is advised, saline drops for the nose and humidifiers bring moisture into the air. Wheezing coughs that last should merit a trip to the physician.

According to the Consumer Health Products Association (CHPA), the cough and cold medicines that were withdrawn are:

  • 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.




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