Drug Topics - November 10, 2008 - (Page 39)

Clinical CONSUMER ALERT FDA SAFETY PAGE Kellie Taylor, PharmD, MPh Inadvertent oral administration of Benadryl itch gel causes adverse events Benadryl is a well-recognized brand name that healthcare professionals and consumers associate with OTC allergy relief products. While many of the Benadryl products are intended for oral ingestion, there are ﬁve products intended for topical use in adults and children. The U.S. Food and Drug Administration (FDA) wants to alert consumers and healthcare professionals that one of the topical products, Benadryl Itch Stopping Gel, has been involved in several cases of accidental oral ingestion. This product contains diphenhydramine HCl (2 percent) and zinc acetate (1 percent) as the active ingredients, but also lists camphor as an inactive ingredient. Camphor is a common ingredient in many topical OTC medications, and its use POWER POINTS is limited to topical and vaBenadryl porized administration only. Itch Stopping Gel Camphor is not intended for contains camphor oral administration and can and is for external be toxic when administered use only. orally. Camphor can cause gastrointestinal symptoms FDA has identi ed seven reports (burning of the mouth and of accidental throat, nausea, and vomitoral ingestion. ing), neurological effects (irritability, confusion, seizures, The incidents resulted coma, and apnea), and has in hospital visits. been associated with death in some cases. In the FDA’s Adverse Event Reporting System (AERS) database, seven reports of medication errors involving accidental oral ingestion of Benadryl Itch Stopping Gel in adults and children have been identiﬁed. The contributing factors to these errors may be due to the packaging conﬁguration of the container and concurrent marketing of oral liquid Benadryl products. Consumers can mistake the Benadryl Itch Stopping Gel product for an oral product instead of a topical product because the container is shaped like a four-ounce bottle of oral liquid medication, with a tapered top. Additionally, the viscosity of the gel is very thin, resembling the viscosity of an oral liquid product rather than a gel product. The incidents of accidental oral ingestion of Benadryl Itch Stopping Gel resulted in serious adverse events that required hospitalization or an emergency-room W W W.D R U GTO P I C S .C O M visit. The reactions reported resulted from acute, onetime ingestion of the product, in quantities ranging from one-half teaspoon to four tablespoons. It’s difﬁcult to assess whether the adverse events resulted from exposure to camphor or diphenhydramine, since the overdose symptoms of camphor (nausea, vomiting, dizziness, headache, and convulsions) and diphenhydramine (nausea, confusion, convulsions, delirium) can appear similar. In light of the serious outcomes associated with these medication errors, the FDA is recommending that pharmacists counsel parents to use caution when purchasing and storing topical products. Here are some measures pharmacists can take to help avoid confusion: In the pharmacy setting, physically separate topical products from products intended for ingestion. Similarly, advise consumers to keep topical and oral products separated when they store OTC products and prescription medicines at home. Remind consumers to read the drug facts label for important product information before administering OTC products. COURTESY OF JOHNSON & JOHNSON If you become aware of medication errors involving Benadryl Itch Stopping Gel or other products, report them to the FDA MedWatch program online at www. fda.gov/medawatch. KELLIE TAYLOR, PharmD, MPh, is Team Leader, Division of Medication Error Prevention and Analysis, Ofﬁce of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA. N OV. 10, 2008 DRUG TOPICS 39 http://WWW.DRUGTOPICS.COM

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Drug Topics - November 10, 2008 Contents Up Front Up Front in Depth Letters Rx Care Government Community Practice First Responders Clinical Practice Self-Care FDA Safety Page Weighing the Complications of Obesity New Products Viewpoint

Drug Topics - November 10, 2008

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