FDA Takes Steps Against Acetaminophen

FDA Takes Steps Against Acetaminophen

Acetaminophen - best known as the over the counter medication Tylenol - took a big hit today.  An FDA advisory panel advised that acetaminophen be removed from popular pain control drugs like Vicodin and Percocet, where it appears along with an opiate.  They also advised that the FDA issue a "black box warning," which is the last step the FDA takes before outright banning the sales of a drug.

This story has so many things which surprise me.  First of all, I didn't realize that Vicodin and Percocet include acetaminophen.  Is the hydrocodone not enough?  I looked around, but I couldn't find an answer as to why these prescription pain medications also include some Tylenol.

Second, I didn't realize that Tylenol can be so lethal.  It is the leading cause of liver failure in the United States, and it's easy to see why.  If you go over the maximum recommended daily dose, you risk liver damage.  That dose is 4 grams.  One tablet of Extra Strength Tylenol has 500 mg of acetaminophen, and a daily dose as low as 7,500 mg can cause serious liver damage.

One Vicodin tablet can contain up to 750 mg of acetaminophen.  If you're on Vicodin for pain control, and you either don't realize that it already contains Tylenol, or you don't realize how dangerous it is, you could step over that 7,500 mg threshold pretty quickly.  And the threshold is lower if you're taking it every day, possibly as low as 4,000 mg.

The statistics - 56,000 cases of liver failure a year - are apparently evenly split between accidental and intentional overdoses in the United States.  Again, it's easy to see why Tylenol would be such a popular choice for suicide.  Aside from its easy availability, ten Extra Strength Tylenol tablets can mess you up good, albeit not in the fatal way most intentional overdosers imagine. 

Evidently, the United States is one of the few countries in the world where you can walk into a store and buy a big bottle of Tylenol.  Many countries, in response to Tylenol's toxicity, have required that it be sold in small blister packs of only 10 or 20 pills per pack.  Heck, I recently pondered the purchase of a gigantic bottle of store brand acetaminophen at Walgreens.  The bottle was about six inches high, and contained 500 caplets.  (I went with the ibuprofen instead.)

Perhaps the biggest surprise in all of this is that Tylenol is ingrained in my consciousness as "the safe one."  I was born in 1972, and the big Reyes Syndrome news (which linked Reyes Syndrome to use of aspirin in children running a fever) hit the scene in the late 1970s and early 1980s. 

We didn't have ibuprofen as an over the counter medication back then, so parents across the country threw away their aspirin bottles and bought Tylenol in droves.  My parents (perhaps suffering from the media fear campaign of the day) thoroughly impressed upon me that I was NOT TO TAKE ASPIRIN.  I guess they were afraid that I would get sick at a friend's house, and be offered the DEADLY ASPIRIN.  To this day, I can't bring myself to take aspirin when I'm sick, even though it's perfectly safe for adults.