Drug Manufacturers Voluntarily Pull Children's Cold and Cough Medicines from the Shelves

Amy Rothschild

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On Thursday, October 11, 2007, drug companies announced that they will voluntarily recall over-the-counter cough and cold medicines for children over the age of two years, even though physicians have warned that the medications could post health risks for children up to the age of six years.

Both phyisicians and federal regulators warned of the potential health risks to children prior to the voluntary withdrawal. Apparently, researchers have identified occasions of patterns of misuse of the over-the-counter medications leading to overdose particularly as to infants.

The researchers found that 54 children had died from 1969 to 2006 after taking kids' medicines that use the ingredients ephedrine, pseudoephedrine and phenylephrine. The Food and Drug Administration (FDA) also found that 69 deaths of children were linked to antihistamines that contained diphenhydramine, brompheniramine and chlorpheniramine. Most of the children who died were under 2, and the FDA said that the medicines haven't been proved to work in little kids. Earlier research by the Centers for Disease Control and Prevention found that 1,500 children under 2 had suffered serious health problems after using the medicines. The American Academy of Pediatrics also has warned that kids' cough and cold products are not safe or effective for kids under 6.

Some of the products being withdrawn include over-the-counter infant cold medicines such as Tylenol, Dimetapp, Robitussin, Triaminic and Little Colds. The companies that manufacture these medications have posted information about alternative products on their websites. The medicines that are being withdrawn are as follows:

According to the Consumer Healthcare Products Association, the brands of cough and cold medicines that are being voluntarily withdrawn are:

• 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

Currently, the labels on these medications recommend that parents consult their physicians before administering them to their infants and toddlers. The Food and Drug Administration and the Consumer Healthcare Products Association, the latter of which represents drug manufacturers, ecommend that the labels read "do not use" for children under the age of two years. The FDA has scheduled public meetings on October 18, 2007 and October 19, 2007 to discuss officially changing the labels.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.