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Drugmakers recall infant cough/cold medicine in U.S.
By Debra Sherman

CHICAGO (Reuters) - Johnson & Johnson . Wyeth and other makers of infants' nonprescription cough and cold products are recalling certain medicines in the United States because of the danger of overdose, the Consumer Healthcare Products Association said on Thursday.

Novartis and Prestige Brands Holdings are recalling their oral infant cough and cold medicines, as well, because data show that when the medicines are misused, it can lead to overdose, especially in children under the age of 2 years.

A spokeswoman for Consumer Heathcare, a trade association representing the makers of over-the-counter medicines, said overdoses have led to death and serious injury in rare instances.

The recall comes ahead of an October 18-19 meeting of outside experts who will make safety recommendations to the U.S. Food and Drug Administration.

Questions have been raised for more than a year about the safety of the use of nonprescription cough and cold products in children and whether the benefits justify any potential risks, especially in children under 2 years of age.

Safety experts for the U.S. Food and Drug Administration have urged the agency to consider a ban on these medicines for children under the age of 6 years.

Many say there is little evidence that these medicines are effective in such young children anyway and are calling for mandatory warning labels that say the medicines should not be used in children under 2 years of age.

Medicines that are being recalled from the U.S. market include: Concentrated Infants' TYLENOL Drops Plus Cold; Concentrated Infants' TYLENOL Drops Plus Cold & Cough; PEDIACARE Infant Drops Decongestant (PSE); PEDIACARE Infant Drops Decongestant & Cough (PSE); PEDIACARE Infant Dropper Decongestant (PE); PEDIACARE Infant Dropper Long-Acting Cough; PEDIACARE Infant Dropper Decongestant & Cough (PE) products; Dimetapp Decongestant Plus Cough Infant Drops; Demetapp 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 and Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.

(Reporting by Debra Sherman)