The U.S. Food and Drug Administration Wednesday warned consumers of the potentially serious side effects of swallowing Benadryl Itch Stopping Gel, an over-the-counter product made by Johnson & Johnson intended for use on the skin.
After several reports of injuries due to people mistakenly drinking the gel apparently thinking it was one of the Benadryl liquid allergy products that are supposed to be swallowed, the company will add prominent warnings “For Skin Use Only” on the gel’s label and on a sticker attached to the cap, according to the FDA.
The action by the company “to help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin” came more than 17 months after a problem was identified by a Philadelphia-area nonprofit.
In January 2009 and again this March, the Institute for Safe Medication Practices (ISMP), a Horsham, Pa.-based group devoted to medication error prevention, warned that it had seen a spate of mistakes caused by people who drink the gel apparently thinking it is the allergy medication.
The group has identified at least eight reports of people swallowing the gel and having serious adverse reactions. These included ER visits and hospitalizations in some cases, according to ISMP’s analysis FDA records.
ISMP's warnings also noted that poor labeling of the gel might be contributing to the problem as the front of the bottle says in small letters “topical analgesic.” The group suggested prominently featuring a warning such as “External Use Only” or “Apply ONLY to the Skin.”
Wednesday the FDA said, “people swallowing the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations and confusion.”
And the FDA said it “encourages manufactures of similar products to adopt similar changes to their labeling and packaging.”