FDA Advisory Committees Recommend Against Cough and Cold Medications in Children Under 6

Citing a lack of proven effectiveness and a need for clinical trials in children, the FDA’s Nonprescription Drugs and Pediatric Advisory Committees recommended the ingredients in cough and cold medications not be used in children younger than 6.

The agency convened a two-day meeting in response to a citizen petition requesting the FDA not allow the drugs to be marketed for children younger than 6. The petition was filed by the Baltimore City Health Department on behalf of several hospitals and universities. Although the petitioners’ request applies to children younger than 6, the agency told the committees any actions it takes could apply to children younger than 12.

The FDA is not required to accept advisory committee recommendations but usually does. Petitioners testifying to the committees argued, based on review of published studies, that cough and cold products intended for use in children have not been proven effective. Therefore, any adverse events associated with their use in the respective patient populations are not appropriate, and use of the drugs in children should be limited.The FDA agreed that the drugs have not been shown to be effective but said it was important to consider the studies were not well designed. If the agency were to act on the advisory committees’ recommendations, it would have to start the rulemaking process.

The panel voted unanimously that the products should not be used in children younger than 2 and voted 13-9 against use in those between the ages of 2 and 6. The committees did not recommend against use of the drugs in children between the ages of 6 and 12, with seven members voting to ban it and 15 not to. However, the members voted unanimously that cough and cold medicines have not been shown effective in children younger than 12.

Source: http://news.google.co.in/news?hl=en&ned=in&q=FDA