Originally Posted by kappys
FWIW I also did a 2 year toxicology fellowship - so this fits into my area of expertise. I know some of the members of the drug safety advisory board for the FDA - but I don't recall exactly who was on the acetaminophen panel.
At any rate its worth remembering that these are vote based findings from a panel that are then put forth to the general voting body of the FDA - somewhat of a parlimentary procedure.
- In a single large overdose tylenol is more dangerous than NSAIDs which tend to be pretty safe. Aspirin is also quite dangerous in such an overdose
- In a chronic overdose - i.e. taking too much pain medicine for some time - both tylenol and NSAIDs can be quite dangerous. Fewer people develop severe liver toxicity from chronic overuse of tylenol than patients who develop serious GI bleeding or kidney injury from NSAIDs, but the latter group tends to do better once identified and treated appropriately. Reducing the tylenol dosing from 500 mg to 325 mg will likely reduce the number of people who develop tylenol toxicity from overuse of pain medications by reducing the total tylenol ingested.
- In appropriate doses - i.e. 4 g of tylenol daily it is much, much safer than appropriate doses of NSAIDS which still carry significant GI bleeding risk. There does appear to be a population which develops mild liver function test abnormalities at these doses but again the consequences are not really clear - no one seems to develop overt liver disease or cirrhosis.
I sat through the mandatory biennial proper prescribing CME lecture last year. I was stunned by the OBNDD's statistics regarding diversion, especially the mortality attributable to diversion of prescription opiates and benzodiazipines. We had approximately 600 overdose deaths last year in this setting, which is just about even with MVC related mortality. Prescription diversion is rampant here, and I would imagine similar trends nationally.
As we have both stated, there is almost no chance for hepatic injury with the proper dose of acetaminophen. Do you think that the diversion trends played any role in the FDA's recommendation to reduce the acetaminophen dose in combined opiate analgesics? More to the point, do you think that knowing the sheer number of people illegally obtaining and abusing these medications had anything to do with the FDA's recommendations?