Drug Makers Voluntarily Recall OTC Infant Cough and Cold Medications

October 18, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

On behalf of manufacturers of over-the-counter (OTC) infant cough and cold medications, the Consumer Healthcare Products Association announced a voluntary withdrawal of products intended for use in children under age 2.

Washington DC (Oct. 11)-On behalf of manufacturers of over-the-counter (OTC) infant cough and cold medications, the Consumer Healthcare Products Association (CHPA) announced a voluntary withdrawal of products intended for use in children under age 2. The reason for the recall is not an issue of product safety; the concern is the possibility of overdose when used incorrectly with children age 2 and under.

Products being recalled are:

  • Wyeth: Dimetapp Decongestant Plus Cough Infant Drops, Dimetapp Decongestant Infant Drops, and Robitussin DM Infant Cough Drops

  • Prestige Brands: Little Colds Decongestant Plus Cough and Little Colds Multi-Symptom Cold Formula

  • Johnson & Johnson: Pediacare Infant Drops Decongestant, Pediacare Infant Drops Decongestant & Cough, Pediacare Infant Dropper Decongestant, Pediacare Infant Dropper Long-Acting Cough, Pediacare Infant Dropper Decongestant & Cough, Concentrated Tylenol Infants’ Drops Plus Cold, and Concentrated Tylenol Infants’ Drops Plus Cold & Cough

  • Novartis: Triaminic Infant & Toddler Thin Strips Decongestant and Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.

“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, 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.”

A review of side effects due to OTC cough and cold medication in children from 1969 to 2006 found 54 reported deaths associated with decongestants and 69 reported deaths associated with antihistamine medicines. Earlier this month, the CPHA made a recommendation to FDA that labels on children’s cough and cold products be changed from “ask a doctor” before use in children under age 2 to “do not use.”

FDA will hold a meeting on October 18 and 19 to further explore safety issues of OTC children’s medicines.

For more information on the voluntary withdrawal, visit otcsafety.org.