Drug Topics - April 21, 2008 - (Page 4)

4 DRUG TOPICS APRIL 21, 2008 www.drugtopics.com Of Interest to Pharmacists Treating kids with cough and cold: Filling the void Kelly Karpa, Ph.D., R.Ph., Megan Barnes, and Avani Patel A debate has been raging over what over-thecounter (OTC) cough and cold products should be used in pediatrics. This debate was prompted by a January 2007 study published in Morbidity and Mortality Weekly Report which noted that 1,519 children were treated in U.S. emergency departments for adverse events related to cough and cold drugs in 2004-2005. The Centers for Disease Control & Prevention and the National Association of Medical Examiners found that three infants under six months of age died from causes attributed to cough and cold drugs in 2005. The underlying causes of deaths were listed as pseudoephedrine intoxication, pseudoephedrine and dextromethorphan intoxication, and drug poisoning. In response to the CDC’s investigation, members of the Food & Drug Administration’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee voted to reject use of these drugs in children under the age of six. As most pharmacists are aware, no FDA-approved dosing recommendations for kids younger than two have ever existed for OTC cough and cold products. However, what R.Ph.s may not know is that safety and efficacy data for kids under 12 had been extrapolated from adult studies. Ian Paul, M.D., M.Sc., associate professor of pediatrics and public health sciences and director of the pediatric clinical research office at Pennsylvania State University College of Medicine, commented, “There are some good data for decongestants, but extrapola- Photo: Jim Shive http://www.drugtopics.com http://www.watson.com

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Drug Topics - April 21, 2008 Contents The 20 Drug Firms Par Excellence in 2007 Treating Kids with Cough and Cold: Filling the Void Promoting Medication Safety: A Community Outreach Event Scholarship Helps Students Get Into Pharmacy New Products Latest News Roundup

Drug Topics - April 21, 2008

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