Has Tylenol had its Day in the Sun?

November 12th, 2009. By janem

Bayer is likely seeing its Tylenol sales drop these past few weeks after the FDA finally took aim at acetaminophen over-the-counter (OTC) products and the media made it headlines.

Many consumers are loyal to certain brands and I’ve taken my fair share of Tylenol over the years, but for me, Tylenol’s had its day in the sun. What’s most disturbing is that the FDA has known since at least 1977 that severe liver damage can occur as a result of acetaminophen overdose. Back then,  their advisers recommended explicit warnings not to exceed the dose or take acetaminophen for more than 10 days, but the FDA never took action.

So now the agency is making up for lost time and warning people that taking a few extra Tylenol pills here and there, thinking OTC meds are safe, could result in acetaminophen toxicity. Isn’t that like shutting the barn door after the horse has bolted? Since 1977!

And the German drug maker (with HQ in New Jersey) may soon take a dive in profits-there’s a new kid on the block touting a safe alternative to acetaminophen.

BioElectronics Corp. recently completed an acetaminophen comparison study and its results will be announced next Monday, November 16. Their timing is ripe to introduce ActiPatch and Allay, alternatives to Tylenol and other acetaminophen products.

“We believe this is important research especially considering the many health concerns expressed by the U.S. Food and Drug Administration relative to Tylenol, NSAIDs and other over the counter pain medications,” said Andrew Whelan, CEO of BioElectronics, Corp. ” We look forward to reviewing the full study data and submitting it to FDA in support of our current pending 510(K) applications and additional applications we plan to file in the future.”

In the meantime, no doubt consumers are studying labels on OTC meds more carefully these days, especially after the FDA’s recent announcement about the dangers of acetaminophen overdose in children’s meds. The FDA committee has insisted that all children’s and infant’s acetaminophen products be sold at the same concentration, simplifying dosing instructions. Currently the labels are confusing– there are several different strengths of liquids, chewables, and “Junior” tablets that give dosage instructions by weight and age.

What I find mind-boggling is how Bayer has controlled OTC pain meds for so long while there are safer alternatives.

Tags: acetaminophen overdose, tylenol

This was posted on Thursday, November 12th, 2009 at 11:55 am and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.