FDA Warning: Swallowing topical Benadryl product may cause serious side effects

05/13/2010 // West Palm Beach, Florida, USA // Sandra Quinlan // Sandra Quinlan

West Palm Beach, FL—The U.S. Food and Drug Administration (FDA) has urged consumers to pay close attention to medication labels, specifically Benadryl Extra Strength Itch Stopping Gel. The over-the-counter (OTC) product is indented for topical use only. However, the FDA has apparently received multiple reports of individuals experiencing adverse side effects due to the accidental consumption of the gel. The FDA issued the warning on Wednesday, May 12, 2010.

According to information provided, consumers have the potential to suffer serious side effects if the active ingredient in the Benadryl Extra Strength Itch Stopping Gel, diphenhydramine, is swallowed. Consumers may experience side effects including unconsciousness, hallucinations, and confusion if the diphenhydramine is ingested in a large enough dose.

Carol Holquist, director of the FDA’s Division of Medication Error Prevention and Analysis stated, “Consumer confusion and incorrect product use are serious public health issues… FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed.”

Since deciphering topical products from those intended for oral ingestion can sometimes be puzzling, Johnson and Johnson (the product’s manufacturer) has taken some steps to make labeling more clear to consumers. According to the FDA, Johnson and Johnson has taken the following measures:

• The statement “For Skin Use Only” has been added to the product label.

• A sticker stating, “For Skin Use Only” was placed on the cap of the product.

• “Initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.”

The FDA also recommended manufacturers of similar OTC products adjust packaging to prevent accidental consumption of topical products.

To report harmful side effects, consumers and health care processionals may contact the FDA’s MedWatch Adverse Event Reporting program or call (800) 332-1088.

Legal News Reporter: Sandra Quinlan- Legal News for Pharmaceutical Liability Lawyers.

Media Information:

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