Cold Med Recall

Related to my post earlier this month, the Consumer Healthcare Products Association released a statement today announcing a voluntary recall of infant cold medications.  The American Academy of Pediatrics press release about the recall follows.

Cough and Cold Medicines for Infants and Children Withdrawn


The AAP applauds the decision of pharmaceutical companies
to withdraw cough and cold medicines for infants and children under 2
years of age. Evidence from controlled trials show that these products
are not effective in children under 6 and can have potentially serious
side effects. Dosage guidelines for cold and cold mixtures are
extrapolated from adult data and thus inaccurate for children.
According to the Consumer Healthcare Products Association (CHPA), the
cough and cold medicines that are being withdrawn are:

  • Dimetapp(R) Decongestant Plus Cough Infant Drops,
  • Dimetapp(R) Decongestant Infant Drops,
  • Little Colds(R) Decongestant Plus Cough,
  • Little Colds(R) Multi-Symptom Cold Formula,
  • PEDIACARE(R) Infant Drops Decongestant (containing pseudoephedrine),
  • PEDIACARE(R) Infant Drops Decongestant & Cough (containing pseudoephedrine),
  • PEDIACARE(R) Infant Dropper Decongestant (containing phenylephrine),
  • PEDIACARE(R) Infant Dropper Long-Acting Cough,
  • PEDIACARE(R) Infant Dropper Decongestant & Cough (containing phenylephrine),
  • Robitussin(R) Infant Cough DM Drops,
  • Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant,
  • Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant Plus Cough,
  • TYLENOL(R) Concentrated Infants’ Drops Plus Cold,
  • TYLENOL(R) Concentrated Infants’ Drops Plus Cold & Cough.

    Treatment of colds/upper respiratory infection should include
    plenty of fluids, rest, use of a bulb syringe to clear nasal passages,
    and in some instances saline nose drops.

    The AAP will be participating in the October 18-19, 2007 joint
    meeting of the FDA Non-prescription Drugs advisory Committee and the
    Pediatric Advisory Committee at which time FDA will discuss the safety
    and efficacy of over-the-counter cough and cold products marketed for
    pediatric use.

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