FDA committees meet on pediatric OTC cough/cold meds

October 25, 2007

A joint meeting of the FDA's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee was held to review "the safety and efficacy of over-the-counter (OTC) cough and cold products marketed for pediatric use."

A joint meeting of the FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee was held to review “the safety and efficacy of over-the-counter (OTC) cough and cold products marketed for pediatric use.” Due to a lack of proven effectiveness and the need for pediatric clinical trials, the committees recommended against the use of these products in children under the age of 6.

The meeting was prompted by a citizen petition submitted to the agency on March 1, which raised concerns about the use of these products in children under 6 years old. It asked, among other things, that the FDA amend the OTC drug monograph for cold, cough, allergy, bronchodilator, and anti-asthmatic medications require labeling to state that they “have not been found to be safe and effective in children under 6 years of age for the treatment of cough and cold.”

The Consumer Healthcare Products Association recently announced that several of the makers of the OTC medications voluntarily pulled their infant formulations from the market over concerns of misuse.The list of withdrawn products is as follows:

Dimetapp Decongestant Infant Drops
Dimetapp Decongestant Plus Cough 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 and Cough (containing phenylephrine)
Robitussin Infant Cough DM Drops
Triaminic Infant and Toddler Thin Strips Decongestant
Triaminic Infant and Toddler Thin Strips Decongestant Plus Cough
Tylenol Concentrated Infants’ Drops Plus Cold
Tylenol Concentrated Infants’ Drops Plus Cold and Cough

The FDA is asking parents to use caution when administering OTC cold and cough medications to their children, especially those under age two, without the advice of a doctor. Other recommendations include:

•Use products marked for babies, infants, or children, and read the “Drug Facts” on the product label

•Do not give other prescription or nonprescription medications in conjunction with cough and cold medicine without first checking with the child’s pediatrician; •

Do not use household utensils to measure out drugs

—use the measuring device provided with the product, or purchase a pediatric dosing device and make sure its markings match the recommended dosages on the drug label, or given by a clinician

To view background materials for the 2-day meeting visit, www.fda.gov/ohrms/dockets/ac/cder07.htm#NonprescriptionDrugs