Makers Take Their Products Off the Market Citing Potential Misuse, Not Safety
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Reviewed By Michael Smith, MD
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Oct. 11, 2007 -- The makers of all over-the-counter oral cough and cold medicines for infants announced that they are taking those products off the market.
"Potential misuse of these infant medicines, not product safety, is driving the voluntary withdrawal," the Consumer Healthcare Products Association (CHPA), a trade group representing the makers and distributors of over-the-counter medicines, states in a news release.
The withdrawal only applies to cough and cold medicines that refer to "infants," not to children who are at least 2 years old.
The CHPA today issued this list of branded cough and cold medicines that are being voluntarily withdrawn:
- 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
- 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
FDA Reviewing Products
In August, the FDA warned parents not to give children younger than 2 over-the-counter cough or cold medicines unless given specific directions to do so by a health care provider.
The FDA is reviewing the safety and effectiveness of nonprescription cough and cold drug use in children. An FDA panel will discuss the topic next week.
Trade Group's Comments
"It 's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," CHPA President Linda Suydam, DPA, says in a news release.
"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," says Suydam.
The CHPA and its member companies have recommended to the FDA that the labels on all over-the-counter cough and cold medicines for children 2 and older be strengthened from "ask a doctor" before using to "do not use" in children under age 2. That way, parents will be aware that these products are not recommended for infants.
The CHPA states it made those recommendations in preparation for next week's FDA panel meeting.
"These medicines are -- and always have been -- safe at recommended doses," says Suydam.
She adds that "these voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children's symptoms."
"But as with all medicines, it's important that parents read over-the-counter medicine labels carefully, use these medicines only as directed, and store them safely out of the reach of children," says Suydam.
SOURCES: News release, Consumer Healthcare Products Association. WebMD Health News: "FDA Warns on Tots' Cough, Cold Drug Use."
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