FDA warns: Don't swallow the itch-stopping gel
Proton Pump Inhibitors such as Nexium are widely used to treat heartburn, although they are intended for more serious and chronic conditions such as bleeding ulcers. In Tuesday's edition of the Archives of Internal Medicine, five studies (1, 2, 3, 4, and 5) and an editorial examine the adverse consequences of the drugs, including a slight increase risk of fractures for women after menopause and an increased risk of a serious bacterial infection.
FDA warns: Don’t swallow the itch-stopping gel
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.”
People are idiots!— Phillygrlatheart- "Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations and confusion.” Sounds like a typical Saturday night for the Tonner.
- beware the coffee is hot!— pw1967
- Kind of reminds me of the story about the woman who got pregnant while using contraceptive jelly. "But doctor...I put it on my toast every day."— phillyexile
- um....read it people! I don't think you can idiot-proof anything but reading the damn label helps!— palmyra21
This sounds like something Ralph Wiggem would do...'Miss Hoover, I drank the gel and now my throat's not so scratchy.'— Ohmy
Comment removed.- Comment removed.
- Do not taunt happy fun ball.— snarfies
- Don't forget the Public Service Announcement to remind these people not to brush their teeth with the Preparation H either!— Catch22
"Do not spray oven cleaner into mouth." (Seriously, it says that.)— verve
- Abington Memorial Hospital
- Agency for Healthcare Research and Quality
- American Medical Association
- Aria Health
- Centers for Disease Control and Prevention
- Centers for Medicare & Medicaid Services
- Consumer Medication Safety site from ISMP
- Cooper University Hospital
- Crozer-Keystone Health System
- ECRI Institute
- Inquirer Health & Science
- Institute for Safe Medication Practices
- Jefferson Health System
- Kaiser Health News
- Kennedy Health System
- Lourdes Health System
- Medical Society of New Jersey
- Mercy Health System
- New Jersey Department of Health and Senior Services
- New Jersey Hospital Association
- NPR.org Shots
- NYTimes.com: Well
- Penn Medicine
- Pennsylvania Department of Health
- Pennsylvania Health Care Cost Containment Council
- Pennsylvania Medical Society
- Pennsylvania Patient Safety Authority
- St. Mary Medical Center
- Temple University Health System
- Tenet Healthcare
- The ACP Advocate Blog by Bob Doherty
- The Chester County Hospital
- The Hospital & Healthsystem Association of Pennsylvania
- U.S. Department of Health and Human Services
- U.S. Food and Drug Administration
- Virtua
- WSJ.com Health
