|J&J Product Integrity Slammed Again - Introducing A Decade of Benadryl Poisonings!|
|May 12, 2010 by Donald Riker, PhD|
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Before long J&J's new logo will be the skull & crossbones in the eyes of consumers. First plant shut downs, out-of-control formulae, recalls, failure to support Tylenol-PM's reason-for-being, and now, in a period of only weeks, Benadryl poisonings that create new product liability exposure. In 2009 P&G's OTC products suffered a string of product quality failures; now in 2010 it appears J&J is assuming that honor. Large healthcare companies need to understand that brand equity is supported not simply as a function of A&P spending but as a result of consumer trust. Until otherwise convinced to the contrary consumers should save their money by buying storebrands they can trust.
FDA's Medwatch announced to consumers today that J&J's Benadryl brand, already hit by recalls due to quality failures, has been implicated in unintentional overdoses leading to serious injury, but no deaths [link]. This incident involves Benadryl Extra Strength Itch Stopping Gel [link]. From 2001 to 2009 J&J had received reports of accidental overdose from 121 consumers (the youngest only 26-months old), seven of which resulted in hospital visits or admissions. Typically adverse events reports (ADR's) represent about 10% of the incidence, or liability exposure. As of today the www.benadryl.com website still has no warning notice or photographs of the new packaging, or alerts to consumers. Silence speaks volumes.
In all these cases it appears that consumers mistook this product as an oral medication for allergy rather than a topical gel for application to the skin. Because the product is packaged in a bottle, is a clear liquid, and says "Benadryl" in large letters some consumers ingested the gel. Not so far fetched. What was J&J thinking?
Benadryl (diphenhydramine) is widely associated by consumers as an oral brand for allergy; most of its sales are from oral forms. Benadryl topical gel for skin application is marketed as a 2% clear gel. Benadryl taken orally is approved up to 50mg/dose. Benadryl can be sedating at doses as low as 6.25mg and traditionally the maximal OTC dose of 50mg is considered by sleep researchers as the gold standard for setting the maximum sedation potential against which other anti-histamines are compared. This dose is chosen because 50mg is very sedating in most people while even lower doses can accomplish the same effect in many individuals. Now if consumers mistook Benadryl Gel as an oral liquid and took a one-tablespoon, or a two-teaspoon, dose how much diphenhydramine would they have taken? The answers are 300 & 200mg respectively, or 6-times, or 4-times, the maximal dose. FDA reports that the highest exposure was in fact 1,200mg (24-times the max)! These overdoses would produce all of the described symptoms, or worse.
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