June 30, 2009

FDA Panel Calls For Tylenol, Acetaminophen Strength Reductions

An FDA panel meeting to come up with recommendations to address tens of thousands of overdoses each year of acetaminophen--ie, Tylenol, Excedrin, your favorite private label brand, etc.--voted today to recommend to the full FDA that the strength of OTC acetaminophen be reduced. The FDA is not bound by their recommendations.

The AP sketches out the problems around the painkiller and the votes:

"But despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.

"FDA's experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.

"The group was not asked to recommend an alternative maximum daily dose.

"The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Extra Strength Tylenol is 1,000 milligrams, or two tablets.

"In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription."

Not to throw too much cold water on these proposals--it's obvious we have rather large problems with acetaminophen in our culture--I'm not sure that there would be much benefit to the FDA adopting these recommendations, aside from looking like it's doing something proactive. If you lower the dose of acetaminophen by roughly 50 percent, then it's not difficult to imagine that patients will simply up the dose they take, buy more bottles of Tylenol at the store and so on, in order to get the same effect. The opportunities for unintended consequences abound, in my opinion.

Why not simply recommend a black box warning for all OTC acetaminophen warning of liver damage through overdosage, etc.?

It's worth noting that the makers of Tylenol have been running commercials in recent months advising patients to be good to their livers by not taking too much Tylenol.

Posted by Philip Dawdy at June 30, 2009 11:10 AM
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Comments

On the other side, try getting codeine without acetaminophen in it. You can't get the aspirin combination version and the just codeine only pill is equally as hard to get in the usa. Acetaminophen is forced on pain medications users and dose most of the long term harm and makes you feel physical ill. But if you ask for a version with less or without you're treated as a junkie just wanting to get high from the narcotic in it. In context I had to fight and argue to get prescribed 1 "Tylenol 4"'s ( 60mg of codeine 300mg acetaminophen instead of 2 "Tylenol 3" 30mg 300mg acetaminophen which works out to 60mg codeine and 600mg acetaminophen. Which sounds like its more but is less medicine in reality. its the same amount of codeine but less 300mg of acetaminophen. Wanting to reduce the toxic poison is viewed as you want stronger pills to get high on..... So this dangerous drug being called out is a good thing. Calm down no one is wanting to bar you from "this med saved my life".

So this drug getting restricted off the market is a good thing, maybe people will start to believe us chronic pain folks . Hell try finding cold medicine without it. You'll have to look closely. This toxic substance is whored out into almost every brand and version.

If the FDA wanted to really help, they need to strip this drug out(or at least lower the paired dosage greatly) of pain medication combinations for the folks who have to take large amounts every day and have no choice "pain that makes you pray death" or "drugs that cause death". Not much of a choice there is it....

But restricting size won't help, people will just take more. People who take more over the recommended dosage will get labeled as druggies and give their lawyers away to duck company responsibility for the damage their product really does. People in pain are viewed as weak and deserving of their suffering and any damage from med's should help learn to shut up and just take it.


Now only if there was a way to help get the word out that suicide attempts with this often fail (seldomly work). You wind up with massive organ damage which kills painfully by a long drawn out (sucks way worse) kinda death. Its not the rose tinted view of drifting peacefully off to sleep fairy tale.

Posted by: Acet isn't the golden child claimed at June 30, 2009 12:51 PM

From a natural health industry perspective, it's taken way too long for the FDA to talk about this: the number one cause of liver failure in the U.S. according to most reports. It always amazes us how the FDA ranks its priorities. A few weeks ago, Zicam was the target after 130 or so people lost their sense of smell, many just temporarily mind you. Where are the priorities. Liver failure vs. no smell? I choose losing my smell. What do you think? Read more: http://swansonvitamins.blogs.com

Posted by: Ben at July 1, 2009 08:16 AM

I was working in voc rehab when acetaminophen was approved for OTC sales. Since we had a ton of people with chronic pain (all of whom, by the way, were treated like crap by the medical establishment for the crime of "he wants his pain to go away") we were apprised of the danger to the liver. I remember thinking at the time "This is crazy. This stuff shouldn't be OTC, it's very dangerous."

It wasn't too long before we had chronic pain sufferers with impaired livers, most of them initially from failed suicide attempts. It's not uncommon for people trapped in chronic pain to come up with suicide as a possible exit.

I have mild asthma and have been told not to take aspirin (it can cause sudden death in some asthmatics, not a good side effect). The docs told me to take Tylenol instead. As if. I did enough liver-trashing drinking in my early twenties to not want to impair it any further. I take nothing when I have a headache now.

People with mental health issues are not the only ones stigmatized, lied to and patronized by the very people who purport to help them. Anyone will chronic pain can tell you all about it.


I

Posted by: Sherry at July 1, 2009 10:02 AM

I am a science writer for a small college newspaper and wrote a pretty comprehensive article titled something like, "The best analgesic for you." Anyway, after interviewing about 6 medical doctors, 5 told me that acetaminophen is extremely dangerous, and should be taken of the shelves. I was pretty shocked, but once they got in to it, I could completely understand why. The alternative? Ibuprofen or Aspirin (although be careful about Aspirin if you're young because of Reye's Syndrome.

Posted by: Mick at July 1, 2009 10:51 AM
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