Benadryl Extra Strength Itch Stopping Gel, an OTC (over-the-counter) medication that should be used only on the skin, can have some serious side effects if swallowed. The trouble is that some OTC Benadryl products are swallowed, and a number people may take the topical medication orally by mistake (topical medication = medication applied onto the skin).
The Food and Drug Administration (FDA), USA, says it has received reports of serious side effects in people who have swallowed the topical medication by mistake. The topical medications active ingredient - diphenhydramine - if ingested (swallowed) can lead to:
Hallucinations
Unconsciousness
Confusion
Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis, said "Consumer confusion and incorrect product use are serious public health issues. FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed."
Several pharmacy outlets and grocery stores sell diphenhydramine topical gels that look quite similar to Benadryl Extra Strength Itch Stopping Gel in their packaging - these products should not be swallowed either.
Johnson & Johnson, the makers of Benadryl Extra Strength Itch Stopping Gel, say they have taking the following actions to help consumers recognize that it is meant for use on the skin:
Altered 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.
Manufacturers of similar products have been encouraged to adopt similar changes to their labeling and packaging by the FDA.
The repackaged product is currently stocked in retail stores. The FDA reminds consumers and health care professionals to always read the "Drug Facts" box to identify active ingredients, directions for use, and warnings before using any OTC drug product.
Source: FDA