[5-12-2010] The U.S. Food and Drug Administration (FDA) has received reports of adverse events in consumers who mistakenly swallowed Benadryl Extra Strength Itch Stopping Gel. Although there are over-the-counter liquid Benadryl products intended to be swallowed, Benadryl Extra Strength Itch Stopping Gel is a topical product that is used on the skin. Benadryl Extra Strength Itch Stopping Gel should NOT be swallowed.
Benadryl Extra Strength Itch Stopping Gel is safe and effective when used on the skin as directed. Swallowing it can result in people receiving dangerously large amounts of the active ingredient, diphenhydramine. This can result in serious adverse events, such as unconsciousness, hallucinations, and confusion (see Data Summary).
To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions:
- Changed the product label to add a new, prominent statement "For Skin Use Only."
- Attached a sticker to the cap of the product that says "For Skin Use Only."
- Initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.
Many pharmacies and grocery stores sell other diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. It is important that consumers not mistakenly swallow these products too. Swallowing these products can also result in adverse events.
FDA encourages manufacturers of similar products to follow Johnson and Johnson's example and adopt similar changes to their labeling and packaging.
- Benadryl Extra Strength Itch Stopping Gel and similar topical products used on the skin should NOT be swallowed.
- These products are safe and effective when used on the skin as directed.
- In your home, store products for the skin separately from products that should be swallowed.
- Read the "Drug Facts" box to identify active ingredients, directions for use, and warnings before using any over-the-counter (OTC) drug product.
- Check with a healthcare professional or pharmacist if you are not sure which OTC product is right for you.
- Report any side effects from the use of OTC products to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.
- When recommending an OTC product to a consumer, discuss the use(s) and route of administration of the product.
- Whenever possible, consider storing oral and topical products separately on store shelves; this may help reduce consumer confusion about how the products are used.
- Report adverse events or medication errors involving OTC products to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.
During FDA's evaluation of medication errors associated with Benadryl Extra Strength Itch Stopping Gel, the agency reviewed the adverse event reports submitted to both FDA's Adverse Event Reporting System (AERS) and the manufacturer, Johnson & Johnson.
Between 2001 and 2009, a total of 121 cases of mistaken ingestion of Benadryl Extra Strength Itch Stopping Gel were reported to the manufacturer. Of these, 7 were considered serious because patients required treatment in the emergency room, hospitalization, or admission to the intensive care unit. In the 7 cases:
- Patient ages ranged from 26 months to 84 years old.
- Reported adverse events included hallucination, confusion, increased heart rate, impaired vision, difficulty walking, unconsciousness, sleepiness, nausea, vomiting, dizziness, and inability to speak.
- All were single-dose ingestions of the topical gel ranging from ½ teaspoon (50 mg diphenhydramine) to 4 tablespoons (1,200 mg diphenhydramine). To compare, the labeled single dose of diphenhydramine for oral ingestion for children and adolescents is 6.25 mg to 12 mg, and the adult dose is 25 mg to 50 mg.
The following factors were identified as contributing to these medications errors:
- Appearance of the Benadryl Extra Strength Itch Stopping Gel is similar to oral liquid Benadryl products; including the shape of the container bottle with a tapered top and a flip top cap.
- Similar liquid consistency between the topical gel and oral liquid products.
- Several oral diphenhydramine products are marketed with the Benadryl name, therefore consumers may mistakenly associate the name Benadryl with oral liquid products.
- Lack of clear and prominent direction on the front panel of the topical gel bottle indicating "for skin use only."
- Consumers not reading the label carefully before using Benadryl Extra Strength Itch Stopping Gel.
|New Product Label:|
(top of bottle)
Old Product Label: