Medication Errors from Swallowing Topical Benadryl Extra Strength Itch Stopping Gel
On May 12, 2010, the Food and Drug Administration issued a drug safety communication titled: Medication errors from swallowing topical Benadryl Extra Strength Itch Stopping Gel.
I am Yolanda Fultz-Morris from F-D-A’s Center for Drug Evaluation and Research.
The U.S. Food and Drug Administration (FDA) has received reports of adverse events in consumers that 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 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 you receiving dangerously large amounts of the active ingredient. This can result in serious adverse events, such as unconsciousness, hallucinations and confusion.
To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has:
- 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 topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. Consumers should not mistakenly swallow these products; they can result in the same adverse events.
FDA encourages manufacturers of similar products to follow Johnson and Johnson's example and adopt similar changes to their labeling and packaging.
FDA provides the following additional information for consumers:
- 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, abbreviated as 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 at the end of this announcement.
We urge consumers to report any adverse events or side effects that may be associated with the use of topical products to FDA’s MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.
Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.