As DT reader Gromit pointed out yesterday, there's something of an "information void" about what medicines and active ingredients are included in the drug industry's recent voluntary withdrawl of cold & cough medicines for 0-2 year-olds, and what medicines the FDA's advisory panel recommended banning for all kids under 6yo.
The medicines in question are generally described as over-the-counter cough and cold medicines for infants and children; that much is clear. For more details on what's included and what's not, click below. One key point to remember: pain reliever/fever reducers like acetaminophen and ibuprofen are NOT on the list.
Last week, the Consumer Health Products Association, which includes all the major drugmakers, published a list of all the infant medicines being withdrawn, sorted by brand name. There are 14 products on the list [source: chpa-info.org]:
* Dimetapp® Decongestant Plus Cough Infant DropsThe FDA Advisory Panel's briefing document for the 10/19/2007 hearing [discussed here, published here] opens with the following:
* 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
* PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
* Robitussin® Infant Cough DM Drops
* Triaminic® Infant & Toddler Thin Strips® Decongestant
* Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough
* TYLENOL® Concentrated Infants' Drops Plus Cold
* TYLENOL® Concentrated Infants' Drops Plus Cold & Cough
[p. 4] OTC cough and cold products are widely marketed and used by parents to treat children with symptoms of the common cold. They are available as either single ingredients or more often as combination products containing one or more of the following: nasal decongestant, expectorant, antihistamine, cough suppressant, and also an analgesic and fever reducer [emphasis added]So yeah, some combination cold medicines containing analgesics and fever reducers are on the line. But not single ingredient analgesics or fever reducers.
This whole ban/review process was begun in February when pediatricians from the Baltimore City Health Department filed a petition. Here's what they wanted reviewed--and banned:
[fda, p. 13] In the typical drugstore, over 30 separate cough and cold preparations are marketed to parents for use in children. Products advertised for use in toddlers and young children are typically liquid formulations or chewable tablets. There include dextromethorphan and guaifenesin for cough as well as chlorpheniramine maleate and phenylephrine for nasal congestion.Interestingly, the petitioners don't mention pseudoephedrine in their intro [though they do cite several infant deaths caused by pseudoephedrine overdoses probably caused by multiple doses of combination medications.]
Other products are labeled as "infant" formulations, display images of babies and infants, and include oral droppers or syringes to dispense medications to children too young to drink from spoons or cups. Examples include products containing acetaminophen and phenylephrine market for coled; products containing dextromethorphan and guaifenesin marketed for cough.
And finally, on pages 27-28, there is a pediatric dosing table of "antihistamine/antitussive/nasal decongestant commonly used ingredients" which includes:
AntihistaminesI think these eight active ingredients are really the beginning and end of the FDA's discussion. Am I missing something? Definitely let me know.
Codeine [whoa, really?]