In this issue’s cover story, we address the search for alternatives to animal testing for drug safety. Using animal models to test the safety of drugs for humans has long been a controversial topic. New assays based on nanotechnology and stem cell science are offering some promise of reducing the need for extensive animal-based testing. But, despite the best efforts of drug researchers to ensure the safety of patients when developing drugs, some issues are out of their hands.
I had just finished proofreading the cover story, when a news item caught my attention: “Benadryl Gel: Use on Skin Only”.
That was the headline on the U.S. Food and Drug Administration’s (FDA) Web site. It seems that some people have swallowed Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin.
Serious side effects of ingesting a dangerous amount of the active ingredient, diphenhydramine, include confusion, unconsciousness, and hallucinations.
It appears that some confusion occurs before the product is used. The Web site www.consumermedsafety.org points to the packaging and labeling of Benadryl Itch Stopping Gel as a possible source of mix-ups. Consumers familiar with other Benadryl products intended for ingestion, such as cough syrup, could grab the wrong bottle by mistake.
Over the preceding week, I had become quite familiar with the labels of anti-itch medicines as I scratched my way through a bout of poison ivy. Nearly all products I reviewed stated clear instructions for the product’s use. Of course, it often was in very small type. And, some should have said: “This really expensive stuff won’t do a darn thing to stop the itching or clear up the rash.” (But, that’s another topic.)
Johnson & Johnson, manufacturer of Benadryl, has added “For Skin Use Only” to the label and a sticker on the cap. The company also initiated consumer studies to better understand factors that may contribute to consumer confusion.
“Consumer confusion and incorrect product use are serious public health issues,” said Carol Holquist, RPh, 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.”
Bottom line, drug companies have a defined level of responsibility for producing safe products. Distinctive packaging and clear instructions can help. But, consumers have a responsibility to observe what they hold in their hand, before they place it to their lips.
In spite of the normal confusion that I experience just by living my life, I have managed to avoid brushing my teeth, eating lunch, and drinking my coffee without mixing up any of the anti-itch formulas with what I was supposed to be ingesting.
Now, if someone could find a way to more clearly label poison ivy—fluorescent orange or neon lights would be great—I would be a happy camper.
This article was published in Drug Discovery & Development magazine: Vol. 13, No. 4, May 2010, p. 4.
Filed Under: Drug Discovery