The FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed.
Ingesting over-the-counter Benadryl Extra Strength Itch Stopping Gel can cause serious health problems, including unconsciousness, hallucinations, and confusion, the U.S. Food and Drug Administration warned Wednesday.
The FDA and Johnson & Johnson warned consumers and notified healthcare professionals about the consequences of mistakenly swallowing the Benadryl itch-relief gel rather than applying it to the skin.
Benadryl Extra Strength Itch Stopping Gel is an over-the-counter product sold by Johnson & Johnson (JNJ). Benadryl is also sold in forms that are meant to be swallowed.
Don’t drink your lotion
Swallowing too much of the gel meant to be rubbed on the skin can result in exposure to dangerous amounts of the active ingredient, diphenhydramine, which in appropriate concentrations is also found in many over-the-counter sleep aids.
Exposure to diphenhydramine can cause numb lips, unconsciousness, hallucinations, sleepiness, dizziness and confusion.
On its website, the FDA noted that many pharmacies and grocery stores sell diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. The agency warns consumers not to swallow these products either.
Confusion and wrong medicine use
The warning came on the heels of reports of serious side effects in people who accidentally swallowed the skin treatment gel.
The FDA said between 2001 and 2009 it has received more than 100 reports of consumers who reported gulping the gel, which they confused with other over-the-counter Benadryl products that are actually meant to be swallowed.
Of those reports, seven were considered serious as the patients required treatment in an emergency room, hospitalization, or admission to the intensive care unit.
"Consumer confusion and incorrect product use are serious public health issues," Carol Holquist, RPh, director of FDA's Division of Medication Error Prevention and Analysis, said in a release, according to MedPage Today. "FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed."
J&J makes changes
Meanwhile, Benadryl maker Johnson and Johnson has taken steps to prevent serious injuries. The gel manufacturer has redesigned the bottle to add a new, prominent statement “For Skin Use Only,” and it also stuck a yellow sticker to bottle cap that states "for skin use" only.
On its website, the FDA noted that many pharmacies and grocery stores sell diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. The agency warns consumers not to swallow these products either.
The FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed. Consumers should also carefully read the “drug facts” box on all over-the-counter drug products and look for warnings and directions for proper use.