Setting the FDA straight on how to manage acetaminophen dangers

Unsafe at any dose

IF people couldn’t do simple math and IF we didn’t occasionally take more than one drug at a time and IF we hadn’t been led to believe for decades that acetaminophen is safe (safe enough for pregnant women and babies even!), then MAYBE the FDA’s recent “fix” would work.

But we can and we do and they did, so it doesn’t.

Less is more

If you’ve lived on this planet for a while, you’re probably aware that acetaminophen (best known by the brand name Tylenol) is one of the most-used drugs in history.

Unfortunately, too many people still are NOT aware that this most popular pain reliever is toxic to the liver – and that it’s very easy to take too much.

Because even if you think you’re avoiding that risk by not choosing acetaminophen, you still could be accidentally taking this dangerous drug.

Here’s the problem: Some prescription painkillers, such as Percocet and Vicodin, are formulated with acetaminophen.

People who take those drugs may not have a clue about their acetaminophen intake unless they read the packaging carefully. So if a patient is taking Percocet to relieve pain, and if he also has a stubborn headache, he might start taking extra strength Tylenol every four hours. Just a couple of days of this regimen may be all it takes to push his liver to the brink.

So the FDA has a solution. They’ve instructed drug makers to limit the added acetaminophen dose to those prescription drugs to a maximum of 325 mg per tablet. In some cases, that’s half the current dose. And that’s good. But here’s what’s better: GET RID OF THE ACETAMINOPHEN!

It’s completely absurd to have ANY of it in there in the first place because acetaminophen is one of the easiest drugs in the world to come by. So when a doctor prescribes a powerful opioid painkiller like Vicodin, all he has to do is say, “By the way, if you get a headache, take a couple of Tylenols.”

Done!

Now for Public Citizen…

And as much as I like to pick on the FDA, they aren’t the only ones that got it wrong this time.

Responding to the FDA action, Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, sent out a press release that sharply admonished the FDA for not curbing dosage on over-the-counter acetaminophen.

According to Dr. Wolfe, the agency should limit the OTC maximum dose to 325 mg per pill. The current maximum is 500 mg.

Right. And who would that protect? Only dunces who would take “maximum strength,” thinking they were still getting the same amount as usual and not realizing their headaches – or other aches – weren’t gone.

For everyone else – that is, for anyone who can figure simple math – an upper limit of 325 mg per pill would be a minor annoyance at MOST. Two pills? I don’t think so. Anyone aiming for their usual 1,000 mg is going to take three, of course. And if they’re absolutely dead set in getting at least 1,000, they’ll take four.

So limiting OTC dosages is pointless at best, and dangerous at worst.

Here’s what we really need: Serious labeling. And none of that “black box” nonsense. The black box warning is about as intimidating as Hello Kitty.

Instead, EVERY product that contains acetaminophen should be labeled with a large, orange box with large black letters that read: “Warning! Overdose or prolonged use of this product may result in death!”

I guarantee you, the death total will drop in the first year.

There. Now wasn’t that easy?

By the way, I’ve been sounding the alarm about the risk of acetaminophen overdose for years. For more information on the dangers and how you can avoid them, you can watch this interview I did: “When Over the Counter Turns Lethal.”

Sources:
“New Steps Aimed at Cutting Risks from Acetaminophen” FDA Consumer Update, 1/13/11, fda.gov
“FDA’s Response to Preventable Acetaminophen Toxicity Problem is Dangerously Inadequate” Statement of Dr. Sidney Wolfe, Public Citizen, 1/13/11, citizen.org