Drug Topics - May 12, 2008 - (Page 54)

54 DRUG TOPICS MAY 12, 2008 www.drugtopics.com Self-Care Are OTC cold remedies safe for kids? Jillene Magill Lewis, R.Ph. eports of children experiencing severe adverse reactions to over-the-counter cold remedies have grown in recent years. In the most tragic cases, the adverse reactions were fatal. The Food & Drug Administration addressed the problem last year. In August, the FDA published a health advisory warning parents about the potential hazards of OTC pediatric cold remedies. The FDA also tasked the Nonprescription Drugs Advisory Committee with addressing the safety of OTC cough and cold drugs for children. Three of the experts presenting evidence at the FDA advisory meeting last October also spoke at the Society of Toxicology annual meeting in Seattle in March. According to Richard C. Dart, M.D., Ph.D., director of the Denver Health Authority’s Rocky Mountain Poison and Drug Center, about four million kids take at least one OTC cough or cold medication each week in this country. In reviewing all reports of fatalities associated with OTC cough and cold drugs, Dart and his colleagues found 107 cases of children who died as a result of taking one or more of the drugs. Ninety-two of the cases were caused by supratherapeutic doses, and doses could not be accurately determined in 15 of the cases. Dart and his colleagues determined that none of the fatalities had occurred when using therapeutic doses of OTC cough or cold drugs. Even if the drugs are safe, do they actually help alleviate cough and Common OTC cough cold symptoms in and cold medicines children? Phillip The poison center referral dose is the dose D. Walson, M.D., at which patients should be referred professor of clinical to the poison center for advice and pharmacology and recommended treatment. director of clinical Therapeutic Poison centrials at Cincinnati dose ter referral Children’s Hospital, Drug (in mg) dose (in mg) said that all four Diphenhydramine 6.25 75 classes of OTC cough and cold remedies Pseudoephedrine 15 160 (antihistamines, deDextromethorphan 2.5-7.5 75 congestants, cough suppressants, and Chlorpheniramine 1 14 expectorants) have Brompheniramine 1 20 been proven safe and effective in adults. Phenylephrine 2.5 40 On the other hand, R Walson said, “Pediatric efficacy is clearly uncertain.” The problem, Walson explained, is there have not been sufficient studies in children to establish the efficacy of OTC cough and cold medications. No one even knows if the doses recommended for pediatric use are appropriate. The pediatric doses for these drugs have been extrapolated from the adult doses. “Adult drug study data can’t be extrapolated to children,” said Wayne Snodgrass, M.D., Ph.D., a pediatrician and professor of molecular toxicology at University of Texas Medical Branch. Walson did agree that extrapolation from adult doses isn’t always accurate for pediatric doses, but he did not agree that extrapolation has no place in determining pediatric doses of OTC cough and cold medications. Extrapolation is needed, he said, but it is still not clear when extrapolation is justified. Both Walson and Snodgrass emphasized that more research is needed to determine whether OTC cough and cold drugs are effective in children and at which doses. Research will take time, and parents need guidance now to prevent further deaths from OTC cold remedies. Manufacturers have responded to the issue by discontinuing the infant versions of their cough and cold products. The FDA has agreed that OTC cough and cold product use in children under two years old is too risky to warrant use. For now, the FDA will continue to allow these products to be available for use in children aged two to six. Dart pointed out that most of the deaths related to cough and cold OTCs resulted from mistakes by parents or caregivers. Using the wrong measuring device, or no measuring device, was a common error. Another common mistake was drug duplication due to multiple products with the same ingredients being used. Duplication also occurred when more than one person administered the drugs. In some cases, children took the medications themselves. In other cases, the drugs were administered to sedate the children. To prevent further deaths, parent education is crucial, Dart said. Improved measuring devices, clear labeling, simplified choices, and mechanical improvements to packaging are other potential solutions. And pharmacists can play a critical role by counseling parents on the proper use of OTC cold remedies. THE AUTHOR is a writer based in the Seattle area. http://www.drugtopics.com

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Drug Topics - May 12, 2008 Contents Latebreakers Letters R.Ph.s Say More Needs to be Done to Prevent Pediatric Drug Errors There's a New School of Thought on Use of Beta-Blockers for Hypertension Cover Story Guest Spot Letters Clinical Practice Special Report Professional Practice Broad Label for New Leukemia Therapy Looks Promising Treating Asthma During Pregnancy Safer than Not, Says New Guide In the Pipeline Clinical Q&A APhA Leader's Plan to Leave Office Takes Center Stage at its Conference Policies Passed at a Glance Giving a Talk to the Community? Check Out These Materials This Foundation has Funds to Spare JP at Large Cover Story: Employers and R.Ph.S: A Win-Win Combo FDA's Ilisa Bernstein Discusses Pharmacy Affairs Legal Q&A Manufacturers Unleash a Rash of Poison Ivy Treatments Are OTC Cold Remedies Safe for Kids? Probiotics are All the Rage: How You Can Capitalize on It CMS' Prices for Round One of DMEPOS Competitive Bidding Raising Concerns CVS Caremark's Mentoring Program Recruits and Retains R.Ph.s Antibiotic Resistance Among Community Pathogens Technology Update New Products Advertisers Index Classified Viewpoint

Drug Topics - May 12, 2008

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