FDA Cracks Down on 'Dangerous' Acetaminophen
Agency wants prescription combo drugs to contain no more than 325mg per dose
By Evann Gastaldo, Newser Staff
Posted Jan 15, 2014 12:25 PM CST
Updated Jan 18, 2014 7:01 PM CST
In this Feb. 19, 2013 file photo, hydrocodone bitartrate and acetaminophen pills, also known as Vicodin, are arranged for a photo at a pharmacy in Montpelier, Vt.   (AP Photo/Toby Talbot, File)

(Newser) – The FDA is taking steps to more closely regulate acetaminophen, issuing an official warning that doses over 325mg may hurt your liver. The FDA is asking doctors to stop prescribing "combination" drugs that contain more than that amount per dose—pain medications including Percocet, Vicodin, and codeine often contain acetaminophen, and patients who've been given those drugs may not realize it, CNN reports. That could lead to a dangerous situation in which they end up taking another drug containing acetaminophen, like Tylenol, thus ingesting an unsafe amount of the drug.

Almost half of all acetaminophen-related cases of liver failure in the US are caused by accidental overdose, Reuters reports. But the FDA warning does not apply to over-the-counter drugs; those will be addressed at a later date. For now, the agency also plans to withdraw approval of any prescription combination drugs that do not comply with the 325mg limit. The FDA first requested the limit in 2011, asking manufacturers to comply by this month, but not all of the drug makers agreed, and some drugs with higher levels of acetaminophen are still on the market. Acetaminophen is more dangerous than you might think, killing 150 people per year and sometimes causing rare skin diseases.

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Showing 3 of 49 comments
Ezekiel 25:17
Jan 28, 2014 10:39 PM CST
Haven't had Tylenol III in a long time but that was some nice junk. But one time while on an ER shift for a CEU credit a doc wanted me to get him some sample packs of extra strength Tylenol from the staff first aid kit in the lounge. I asked him if a single 2-pack was fine. They had 500mg tablets. He said, "bring me four 2-packs, I have a raging headache." I asked, "Isn't that a bit extreme?" He replied, "Oh, you're the surgeon now?" I got him the packs and he dropped them all with a diet coke. Oh well, he's the doc.
Jill MacCartney
Jan 19, 2014 7:05 PM CST
My husband is seriously allergic to it, and discovered that when given a a painkiller after an accident several years ago. They almost killed him! Now he can't take any pain killers carried by Kaiser, because they ALL have Acetaminophen in them. After he broke his foot in a motorcycle accident last year, he just had to suffer. How ridiculous!
JBHK
Jan 19, 2014 3:38 PM CST
I can't believe anyone didn't already know this. It says this on every bottle of Tylenol.