Navigation Links
FDA: Serious Side Effects from Swallowing Topical Benadryl Product
Date:5/12/2010

SILVER SPRING, Md., May 12 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is warning consumers about potentially serious side effects from mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

The FDA has received reports of serious side effects in people who have mistakenly swallowed the product. Some OTC Benadryl products are intended to be swallowed. However, Benadryl Extra Strength Itch Stopping Gel is only safe and effective when used, as directed, on the skin.. 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.

"Consumer confusion and incorrect product use are serious public health issues," said Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis. "FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed."

Many pharmacies and grocery stores sell diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. It is important that consumers also avoid swallowing these products.

To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions:

  • Changed 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.

The FDA encourages manufacturers of similar products to adopt similar changes to their labeling and packaging.  

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.

Consumers and health care professionals are encouraged to report adverse side effects to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

For more information

FDA 101: Medication Errors

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048644.htm

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Medical Research Council Technologys Centre for Therapeutics Discovery Opens its First Call For Targets in an Effort to Develop Drugs in Areas of Serious Unmet Need
2. Dermatologists Caution That Severe Cases of Psoriasis Can Be Associated With Other Serious Medical Conditions
3. Genomas Clinical Study Finds Increased Prevalence of Drug Metabolism Deficiencies in Patients With Serious Psychotropic Side Effects
4. FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
5. Video: New Survey Finds Mothers See Influenza as a Serious Health Threat, but Often Dont Get Their Families Vaccinated
6. VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease
7. Omega-3 Fatty Acids Critical to Infants, Mothers and the Seriously Ill
8. The Largest Ever Study of Diabetes Shows Intensive Glucose Control Reduces Serious Complications
9. Vermillion and the Ohio State University Report That Novel Diagnostic Test May Help Predict Risk for Relapse of TTP, A Serious Blood Disorder
10. Infant Formula Manufacturers Again under Ethical Cloud: Marketing Gimmick Linked to Serious Illnesses
11. Simple Test Accurately Predicts Risk of Serious Jaundice in Newborns
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... May 24, 2016   ... beide primären Endpunkte und demonstriert Ebenbürtigkeit ... ‚ausgezeichneter plus guter , ... ,      (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a ... neue positive Daten von der MORA-Studie der Phase ...
(Date:5/24/2016)... 2016 Celsion Corporation (NASDAQ: ... provided an update on its ongoing OVATION study, ... GEN-1, the Company,s DNA-based immunotherapy, with the standard ... with advanced ovarian cancer who will undergo neoadjuvant ... an IL-12 DNA plasmid vector formulated as a ...
(Date:5/24/2016)... -- Open Access Journal Focusing on ... Elsevier , a world-leading provider of scientific, technical ... launch of Clinical Neurophysiology Practice ... clinical practice issues in clinical neurophysiology. The journal will ... and didactic reviews. It is an official journal of ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... Nike Yoga ... activities from daily practices, arts & crafts, discussions, and games all geared towards ... Christy Evans have combined backgrounds in kids’ yoga, collegiate sport yoga instruction, and ...
(Date:5/26/2016)... ... May 26, 2016 , ... Eugene Batelli, ... Along with his wonderful accolades and stellar patient reviews, Dr. Batelli continues to ... , Dr. Eugene Batelli is a highly trained Podiatric Surgeon who specializes in ...
(Date:5/26/2016)... ... May 26, 2016 , ... OncLive® ... added National Cancer Institute-designated University of Virginia (UVA) Cancer Center to ... OncLive’s editorial and marketing teams will publicize and promote public awareness of UVA ...
(Date:5/26/2016)... ... May 26, 2016 , ... The introduction of our professional athletes ... YOUR HEAD ™”. , “We are proud to introduce Meghan Klingenberg, defender ... we have Brian Quick, wide receiver for Los Angeles who was a second round ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... safety efforts for several years, and the efforts have paid off. Since ... include new standards of care to enhance perioperative patient experiences and reduce costly ...
Breaking Medicine News(10 mins):