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WASHINGTON - Manufacturers of OTC cough and cold medicine yesterday began withdrawing infant oral cough and cold medicines due to their potential for misuse, according The Consumer Healthcare Products Association (CHPA) here, which announced the withdrawl on behalf of the suppliers.
"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda A. Suydam, D.P.A, president of CHPA. "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."
The branded cough and cold medicines that are being voluntarily withdrawn are:
- Concentrated Tylenol Infants' Drops Plus Cold
- Concentrated Tylenol Infants' Drops Plus Cold & Cough
- PediaCare Infant Dropper Decongestant
- PediaCare Infant Dropper Long-Acting Cough
- PediaCare Infant Drops Decongestant (containing pseudoephedrine)
- PediaCare Infant Dropper Decongestant & Cough
- PediaCare Infant DropsDecongestant & Cough (containing pseudoephedrine)
- Dimetapp Decongestant Plus Cough Infant Drops
- Dimetapp Decongestant Infant Drops
- Little Colds Decongestant Plus Cough
- Little Colds Multi-Symptom Cold Formula
- 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
This voluntary withdrawal does not affect medicines intended for children age two and older.
According to a report in the Waal Street Journal, On Sept. 28, the FDA released reviews of the medications by its staffers and other groups. Agency safety reviewers said their analysis suggested use of some of the drugs was associated with serious side effects and some deaths in patients younger than 6. The FDA noted, however, that the agency hadn't come to a final conclusion about how to deal with the products.
The FDA said in the documents that it had received 54 reports of deaths in children linked to decongestants containing the ingredients pseudoephedrine, phenylephrine and ephedrine from 1969 to Sept. 13, 2006, and 69 reports of deaths linked to antihistamines with the ingredients diphenhydramine, brompheniramine and chlorpheniramine, the Wall Street Journal reported. The agency said the bulk of the reports were in children younger than 2. Some of the deaths occurred in children who received overdoses, and an FDA official said the agency worried that parents might be inadvertently giving young kids multiple medications that contained the same ingredient.
The agency said it plans to hold a public meeting of a committee of outside advisers on Oct. 18 to examine the safety and effectiveness of the over-the-counter cough and cold medicines in young children, focusing on kids younger than 6.
CHPA and its member companies have put forth recommendations to the U.S. Food and Drug Administration (FDA) to strengthen the labels on all oral OTC children's cough and cold medicines from "ask a doctor" using to "do not use" for children under two years.
These recommendations were made in preparation for a joint FDA advisory committee meeting on October 18 and 19.
CHPA will be launching a major, multi-year national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse, and pharmacist organizations.
More information about the voluntary withdrawal can be found at www.OTCSafety.org.