Originally Posted by kappys
Question 10 (Vote)
Indicate the single option, including both nonprescription and prescription options, which you recommend that FDA consider its highest priority. If you do not recommend that FDA implement any of the proposed options, please indicate this on the ballot provided.
Note: Options 1a and 1b may be considered a single option or two separate options.
9 members voted for Option 1a and 1b, as a single option.
3 members voted for Option 1a only - Reduce maximum dose of OTC acetaminophen
1 member voted for Option 1b only - Switch current maximum dose of OTC acetaminophen to prescription
0 members voted for Option 2 - Establish pack size limits for OTC products
2 members voted for Option 5a – Eliminate OTC acetaminophen combination products.
7 members voted for Option 6 - Limit OTC liquid formulations
7 members voted for Option 5b - Eliminate prescription acetaminophen combination products
1 member voted for Option 3 - Require unit of use packaging for prescription acetaminophen combination products
7 members voted for Option 4 - Require a boxed warning for prescription acetaminophen combination products
No member indicated on the ballot, that they did not recommend that FDA implement any of the proposed options.
1 member voted for C – No, I do not recommend this change.
Here's an article on Question #10 kappys posted above (writer mistakenly lumps Rx and OTC votes together)
Published: June 30, 2009
ADELPHI, Md. June 30 -- An FDA advisory panel voted 36 to 1 to recommend a "black box" warning for prescription medications that combine acetaminophen with another drug. If the FDA follows the advice, it would slap its strictest warning on prescription pain medications that combine acetaminophen with hydrocodone (Vicodin), oxycodone (Percocet), or codeine (Tylenol 3).
"History has been that some of these medications have [seemed] safe and effective and now we're saying they're not," said committee chairman Lewis Nelson, MD, an emergency medicine physician at New York University Medical Center. The panel voted for the warning after two days of hearings on ways to reduce acetaminophen's liver damage risk.
The FDA does not have to follow the advice of its advisory committees, but it usually does -- particularly when there is a substantial majority behind a proposal.
About 42,000 people visit emergency departments each year with acetaminophen overdoses, half of which are accidental. They often occur when a consumer unknowingly takes more than one acetaminophen product.
One advisory panelist attributed 10% of fatalities from acetaminophen overdoses to combination products.
The blue highlight is pretty important I think. Near the end of the last post I asked whether and how frequently these dangers manifested in plain Tylenol, OTC settings, as opposed to the comination drugs. If I'm reading that right, 90 percent?
Originally Posted by Dr. Broncenstein
You personal opinion of me is just that. If your ad hominem makes you feel better, then keep after it. I won't get offended. I certainly won't call you names. I will point out if your medical opinion on this football board is dumb and/or dangerous. I'm sorry if that hurts your feelings, but it's my honest evaluation. I would expect nothing less in return if I offered a comparable legal analysis to this football board.
My feelings are fine, pal. I'm sorry I questioned your credentials, but you repeatedly cited your micro experiences in this macro issue.
Look, the huge number of NSAID deaths sounds very disturbing. A small amount can be explained by their much greater market share, but they're still disturbing. My problem is - I keep wondering - where is the outcry in the medical community? Has the FDA investigated banning aspirin? What are the Lancet and the others missing that you understand?