Drug Topics - November 26, 2007 - (Page 4)

4 DRUG TOPICS NOVEMBER 26, 2007 www.drugtopics.com Of Interest to Pharmacists FDA’s cough and cold recommendations may impact other products Kathryn Foxhall wo Food & Drug Administration advisory committees, meeting jointly last month, voted 13 to 9 to recommend that cough and cold over-the-counter medications not be used for children older than two and less than six years old. It also voted 21 to 1 to recommend that the products not be used in children under two. In contrast, the committees voted 15 to 7 against a statement that would have opposed the medications’ use for children over six and under 12. The panel members did not say the drugs are not effective in children, although there was skepticism on that point among some of them. They did state that they had not seen adequate studies to indicate that effectiveness. The committees asked that careful studies be done to prove the medications’ efficacy in children. Those studies will probably take at Two FDA advisory committees least two to three years, said John voted to recommend that Jenkins, M.D., director of the Office cough and cold OTCs not be used in children older than two of New Drugs, in the FDA’s Center and less than six years old. for Drug Evaluation and Research. T Many of these cold products also have labeling statements for other indications. The FDA monograph for these medications is the same one for the bronchodilators and some allergy products, Jenkins stated. He also said the agency must decide what the implications are for hay fever and other types of allergic conditions. Combination forms The committees also voted for these products to be allowed in combination forms, if safety and efficacy of the separate ingredients are demonstrated, for children over two and under 12. The FDA had asked the panel about such combinations in light of concerns that caregivers may use several products and not realize the same ingredient is in more than one. In discussions on the FDA’s list of questions—with many of the conversations held without a specific vote— the committees also urged that safety improvements be made in labeling, dosing instructions, and dosing devices. Some committee members questioned whether it is feasible to do studies large enough to identify relatively rare adverse events for these products. But Marie Griffin, M.D., a Vanderbilt University School of Medicine professor, cited some large trials that have been done on other drugs and said, “It may be beyond the scope of manufacturers to do this, but it may be in the interest of the public and government to support these trials for a very, very common condition for drugs that are used by half of the population.” In testimony prior to the committees’ discussion, Winnie Landis, president, American Pharmacists Association, told the panel, “Unfortunately, despite a recommendation from a physician or pharmacist not to use a cough or cold product in children under six, parents do give such medication out of desperation to do something to address their child’s health needs. This is a patient safety issue that may be more common than we like to admit.” Of the 22 voting members on the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee, a majority was made up of professors of medicine and epidemiology. There were also experts in pharmacology and pharmacoepidemiology. Information about the issues and the meeting can be found at www.fda.gov/oc/advisory, under “FDA Science Board: Pediatrics,” then under “briefing document.” THE AUTHOR Follow the leader The FDA usually follows the recommendations of its advisory panels. However, in a press conference after the meeting, Jenkins said officials need to “discuss within the agency all the advice and recommendations we heard so that we can decide what our course of action will be.” The agency must go through a formal rule-making process to change the drugs’ labeling, which could take a year or longer, but Jenkins said the FDA may get back to the public soon with interim recommendations. The committees discussed extensively the issue of whether efficacy data should be extrapolated from adults to children for these products and voted that extrapolation was not appropriate for children under 12. Jenkins pointed out that the vote was “in contradistinction to the advice that we received approximately 30 years ago for the original cough and cold panel for the monograph process.” Jenkins noted that extrapolation from adults to children has been done for other medications. He said the agency would have to think about whether the committees’ advice is pertinent only to the cough and cold arena or if it has broader implications. is a writer based in the Washington, D.C., area. Photo: Kathryn Foxhall http://www.drugtopics.com http://www.fda.gov/oc/advisory

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Drug Topics - November 26, 2007 Contents Cough & Cold Recommendations May Impact Other Products More Novelty OTCs Elbow Onto Store Shelves Medication Reconciliation Policies Incomplete at Many Hospitals Hospitals Regress in Reconciling Drugs in 2006 Latest News Roundup

Drug Topics - November 26, 2007

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