FDA Issues Warning Regarding Benadryl Itch Stopping Gel

The Food and Drug Administration (“FDA”) and the Institute for Safe Medication Practices (“ISMP”) recently reported that consumers were swallowing Benadryl Itch Stopping Gel, an over-the-counter (“OTC”) product that must be used topically.  Orally ingesting the product can cause serious adverse reactions, including death, burning of the mouth and throat, nausea and vomiting, irritability, confusion, seizures, coma and respiratory failure.

 

The FDA and ISMP have suggested that the way Benadryl has packaged this particular product is the reason consumers are ingesting the product rather than applying it topically to the skin.  Instead of being packaged in a tube – like many other OTC topical products – Benadryl Itch Stopping Gel is sold in a 4 ounce bottle.  Thus, the FDA points out, consumers believe they are purchasing an oral liquid which should be ingested instead of applied topically.  Moreover, adding to consumer confusion, Benadryl Itch Stopping Gel has the same shape and size as other oral liquid products.  And although the words “external use” appear on the back of the bottle, the front of the bottle states “Topical Analgesic” in small letters, which “consumers could miss or not understand."  The ISMP claims that, "The packaging and labeling of Benadryl Gel is one of the key contributing factors associated with these errors."

 

If you or someone you know has ingested Benadryl Itch Stopping Gel and has been injured as a result, please contact us to discuss your legal options.