Benadryl Overdoses Lead to FDA Warning: Do Not Swallow Itch Stopping Gel

Federal drug safety officials are warning people not to attempt to swallow or consume Benadryl Extra Strength Itch Stopping Gel after receiving reports that seven people have been hospitalized with Benadryl overdoses. 

The FDA released a drug safety communication on Wednesday, and is putting out pamphlets and created a new website to alert the public that Benadryl’s itch stopping gel is not meant to be ingested.

At least 121 people are known to have swallowed the gel between 2001 and 2009, resulting in negative side effects. Seven of those people required emergency medical care, including admission to the intensive care unit in some cases. The ages of those who were hospitalized ranged from 26 months old to 84 years old.

Benadryl Extra Strength Itch Stopping Gel, manufactured by Johnson and Johnson, is a topical product meant to be applied to the skin, not eaten. It contains high concentrations of the active ingredient, diphenhydramine, an antihistamine which can result in a drug overdose. It can also cause hallucinations, unconsciousness, sleepiness, difficulty walking, dizziness and an inability to speak.

In response to the reports, Johnson and Johnson has added both a new statement to the label and a sticker to the cap, prominently warning that the product is “For Skin Use Only.” The company has also begun consumer studies to determine what could lead to customers mistakenly ingesting the gel.

The FDA warns that there are a number of other topical gels on the market that are similar to Benadryl gel and often have very similar packaging. It is warning consumers to avoid swallowing those products as well, and is in the process of encouraging the manufacturers to make labeling changes making it clearer that the gels are not meant to be swallowed.

The FDA recommends that consumers:

• Never swallow Benadryl Extra Strength Itch Stopping Gel or similar topical products.
• Store products for the skin separately from products that should be swallowed.
• Read the “Drug Facts” label on the box to identify active ingredients, directions for use, and warnings before they start using any over-the-counter medication.
• Check with a doctor to make sure that over-the-counter products are safe for them to use.

The FDA is also calling on anyone who has suffered adverse side effects from ingesting Benadryl Extra Strength Itch Stopping Gel or similar products to contact the FDA’s Medwatch Adverse Event Reporting program at www.fda.gov/MedWatch.