FDA considers new rules for kids
WASHINGTON —Pharmacy retailers can expect parents to be even more confused about what to give their sick kids this year during cold and flu season. The confusion follows an Oct. 2 Food and Drug Administration hearing on the appropriate use of pediatric OTC cough-cold remedies, followed closely by a move among makers of these medicines to issue new package labels to alert parents that the products are not for use in children under 4 years old.
Run the numbers and it leaves one huge hole in the market. The more than 20 million U.S. children under age 6 are expected to suffer, on average, three to eight colds this year, multiplying the opportunities for pharmacy retailers to help mom find alternative remedies.
The Consumer Healthcare Products Association earlier this month announced that its members have initiated a voluntary label change to advise parents that use of the medicines is not advisable in children under age 4. As of press time, many products with new labels already had begun to ship to retailers.
Makers of these products insist that it is not the safety of these products but rather how people use them that is the real issue. “Research shows that dosing errors and accidental ingestions—not the safety of the ingredients themselves when properly dosed—are the leading causes of rare adverse events in young children,” explained Linda Suydam, president of CHPA. “As a result, the leading manufacturers of oral OTC pediatric cough-cold medicines are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines.”
In addition, CHPA manufacturers voluntarily are adding language that warns parents not to use antihistamines to sedate or make their child sleepy, and the organization also has expanded its national education program on the appropriate dosing and use of OTC medicines in children.
Meanwhile, CHPA continues to back pediatric pharmacokinetic and efficacy studies on the seven most common monographed cough-cold ingredients. Together with pseudoephedrine, which already is backed by PK studies, those eight ingredients represent approximately 95 percent of the OTC products for children on the market, Suydam said.
Those closest to the situation have told Drug Store News it is unlikely that any action by the FDA could occur before the end of 2010, as any proposed change to the respective monographs would be followed by a comment period before any rule change. By that time, the CHPA studies could very well be complete, providing proof of the safety and efficacy of these medicines in a clinical setting.