At the press conference that followed the votes, members of the FDA panel had the opportunity to address the question as to why they would recommend eliminating prescription acetaminophen combos, but not their OTC counterparts.
"It seems to me that the problems with [prescription] opioid combinations are really more prevalent," said Dr. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology, for the FDA's Center for Drug Evaluation and Research (CDER). "The data presented shows that here were many deaths annually in this country from the prescription of combination acetaminophen products, whereas the number of deaths that can be clearly related to the over the counter products appears to be much more limited."
Because the split on the prescription acetaminophen combo vote was so close, it is unclear whether the FDA will adopt the recommendation, as the FDA does not have to follow the advice of its advisory committees. But if it did, some options would be eliminated for pain patients. For instance, patients taking Vicodin would not have an acetaminophen-free option because there is no hyrdocodone-only formula.
What is far less uncertain is that the advisory panel's votes could mean big changes for acetaminophen. In particular, the 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).
Meanwhile, a less-than-overwhelming 21 to 16 majority voted to recommend that the FDA lower the maximum daily dose for acetaminophen below its current 4,000 mg.
It also voted that to lower single adult dose to 650 mg. While there is a 650 mg extended-release acetaminophen tablet, the most common is the 325 mg pill, so patient would be instructed to take no more than two at a time.
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