Magazine article Drug Topics

Inadvertent Oral Administration of Benadryl Itch Gel Causes Adverse Events

Magazine article Drug Topics

Inadvertent Oral Administration of Benadryl Itch Gel Causes Adverse Events

Article excerpt

FDA SAFETT PAGE

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 ac- tive ingredients, but also lists camphor as an inactive ingredient. Camphor is a common ingredient in many topical OTC medications, and its use is limited to topical and vaporized adrninistration only. Camphor is not intended for oral administration and can be toxic when administered orally. Camphor can cause gastrointestinal symptoms (burning of the mouth and throat, nausea, and vomiting), neurological effects (irritability, confusion, seizures, coma, and apnea), and has been associated with death in some cases.

In the FDA's Adverse Event Reporting System (AERS) da- tabase, seven reports of medication errors involving accidental oral ingestion of Benadryl Itch Stopping GeI 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 visit. …

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