FDA ADVISORS REVIEW RISKS OF OTC COLD PRODUCTS

OCTOBER 01, 2007

New federal regulatory restrictions on the sale of OTC cough and cold medications may be in the cards, as key advisors to the FDA take a fresh look at the safety and effectiveness of these products for children.

Concern has been mounting within the agency that the risks posed by OTC cough and cold products may outweigh their potential benefits for children 2 years old or younger. This issue will be examined this fall by 2 separate FDA panels-the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. Both groups have been directed to make suggestions concerning the rationale behind dosing recommendations for age groups younger than 2 years, 2 to 5 years, and 6 to 11 years.

The FDA advisory committees also will examine "misuse, potential for misuse, unintentional overdose, and excessive dosing; [and] the aptitude of parents or caregivers to administer OTC cough and cold medications to children properly."

Pending the recommendations, the FDA already has issued a public health advisory urging parents to ask pharmacists or other health care providers to conduct a review of potential drug interactions if a child is being given a combination of OTC and prescription medications.

Additionally, the FDA said that parents should ask "about appropriate cough and cold medications based on the child's symptoms, since these products vary in strength."



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