14 Children's Cold Meds Withdrawn From the Market

Johnson & Johnson today recalled several infant cough and cold medicines, citing “rare instances of misuse leading to overdose, particularly in infants under two years of age.”

The FDA recently issued a public heath advisory warning parents of the risk of overdose from OTC cough and cold medicines when administered to children under 2, and has been taking a much closer look at cold and cough medicines marketed towards small children. Safety experts advising the FDA on the issue have been recommending that the drugs be pulled from the market.

According to a safety report commissioned by the FDA, at least 54 children died after taking decongestants, and 69 died after taking antihistamines from 1969 to 2006. The report also suggested that that those numbers were probably significantly understated because deaths from overdose are “reported voluntarily and fitfully.”

The following products are being recalled by Johnson & Johnson:

  • 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

On Oct. 18, the FDA’s Nonprescription Drugs Advisory Committee will meet to discuss the issue.

McNeil Consumer Healthcare Is Voluntarily Withdrawing Infants’ Cough And Cold Products (Press Release) [Johnson & Johnson] (Thanks, M.!)