The solution to the acetaminophen crisis is simple, but the FDA won't sound the urgent warning

Panel of one

How many FDA experts does it take to change a light bulb?

I have no idea. But I can tell you how many it takes to pretend they see clearly, even in a pitch-black room: 37.

That’s not a panel of experts, it’s a BUSLOAD of experts.

And yet, it took that many to come up with a pointless recommendation to protect consumers from acetaminophen overdose.

Seeing orange

A recent article reminded me of this 2009 expert panel. That gang of 37 recommended a ban of the prescription painkillers Vicodin and Percocet because they contain acetaminophen.

Oddly, the panel did not call for a ban of Theraflu or any other over-the-counter med with acetaminophen.

And it took nearly 40 people to come up with that nonsense!

But the FDA response was just a pointless. Last year, agency officials reduced the amount of acetaminophen allowed in the two painkillers.

Um…FDA, why not just REMOVE acetaminophen from these drugs?

What a concept! You’ve got pain? Take a painkiller. Got a headache too? Take some Tylenol. Problem solved!

But that still leaves the issue of acetaminophen overdose. And it’s a huge problem. Many thousands visit an ER every year with their livers on the brink of failure. Sadly, hundreds die. Every single year.

But it doesn’t have to be that way. Because there’s a very simple solution. And the FDA knows the solution. But Johnson & Johnson (maker of Tylenol) and other drug companies would never allow it.

Create a powerful warning.

We often hear about the dreaded Black Box Warning. As we’re always reminded, it’s the most “severe” warning required by the FDA. And what is it? It’s a box made of four thin black lines.

It has all the severity of a kumbaya sing-along.

You want severe? Let’s put up a warning nobody will ever miss. Make it an Orange Box Warning. And no puny lines. I’m talking about a quarter-inch border in Day-Glo orange. Put it on every product that contains any amount of acetaminophen. Put it on the box. Put it on the bottle. Put it on the lid of the bottle. Put it on an insert inside the box.

I guarantee — in one year, accidental overdoses will plummet.

For anyone who thinks that’s overdoing it, I’d like to share two stories.

In 1995, Marcus Trunk began taking a codeine with acetaminophen to treat a sprained wrist. When he developed flu-like symptoms, emergency room doctors gave him further doses of acetaminophen. Within days, Marcus died of liver failure. He was only 23 years old.

In 2008, University of Oklahoma coed Madalyn Byrne used high doses of acetaminophen to relieve toothache pain. She died of liver failure at just 19.

These two young people, and many more, would still be alive if the warnings on their medications were impossible to miss. Or if more people knew about — and talked about — the serious dangers of this seemingly innocent drug.

FDA, stop futzing around with questions of recommended dosage. That’s a comparatively minor issue. Job one: post an unmistakable warning and get the word out.

Problem solved.

Sources:
“Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure” FDA Drug Safety Communication, 1/13/11, fda.gov