U.S. panel said that children under age 6 should not get non-prescribed cold medicines including Johnson & Johnson’s PediaCare and Wyeth’s Dimetapp.  

No evidence has been found that the product work in children under age 12, concluded by the outside advisers to FDA. The panel said the risk of deadly overdoses and other side effects is greatest in the younger kids, the panel stopped short of calling for products to be pulled from the market.  
 
Last week, drugmakers decided to withdraw 14 cold medicines for infants after pediatricians asked the safety of product.

FDA got 54 reports of deaths of children related to decongestants and 69 associated with antihistamines from 1969 to 2006, involving both prescription and non-prescription drugs.

FDA should give drug-makers 3 years to do studies of over-the-counter remedies in kids, said the panel.

Dennis Bier, director of the Children’s Nutrition Research Center at Baylor College of Medicine in Houston, said “We haven’t demonstrated one way or the other whether or not they are efficacious, and we should have the opportunity to do that.”

In the advisers’ meeting in Silver Spring, Maryland, it was recommended adding warnings to product labels against use in children under age 6, standardizing dosing devices and measurements and banning marketing phrases such as “Doctor Recommended.”

John Jenkins, director of the agency’s office of new drugs, said, “The Recommendations won’t necessarily lead to a ban on the products, and parents should follow dosing directions and consult their doctor with any questions. Our advice in general remains to be cautious and aware about over-counter medicines when you are using them. FDA has never approved labeling for these products or recommended use under the age of two.”

“Drugmakers may discuss voluntary changes in labeling with the agency”, he added.

Market research firm AC Nielsen said that the sales of over-the-counter cold remedies for children rose 20 percent to $311 million in year ended Sept. 8., including Novartis AG’ Triaminic, J&J’s Children’s Tylenol Plus Cold, Prestige Brands Holdings Inc.’s Little Noses and Procter & Gamble Co.’s Pediatric Vicks 44 Expectorant.

Linda Suydam, president of the Consumer Healthcare Products Association, said, “Drugmakers will complete the clinical studies recommended by FDA panel.

Around 95 million packages of non-prescribed cold medicines for children are sold each year.   

The risks of products originate from overdoses and can be decreased by better educating parents, told the consumer products trade group.  The organization advised a warning to all pediatric cold drugs, “Do not use in children under 2” and a caution on antihistamines stating, “Do not use to sedate children.”   

Child’s cold can be best treated with plenty of liquids, saline drops and moist air.