Black Box, Mixed Message? FDA Panel Delivers Acetaminophen Recommendations

"The inconsistency is that they don't address the over the counter combination products -- the 'all-in-one' combinations of cough, 'congestion' and 'fever' products that have acetaminophen, and only reveal the amount of acetaminophen in really small print on the back," said Dr. Timothy Collins of the Pain and Palliative Care Clinic at Duke University Medical Center. "These products are the ones that have given me concern with my own patients, because many patients are not aware that their 'cold, cough and fever' product has acetaminophen in it, and take it along with their pain medications."

Meanwhile, family practitioners and rheumatologists -- those who regularly prescribe acetaminophen-containing medicines to their patients -- expressed some concerns over the recommendation that would eliminate medicines like Vicodin and Percocet.

"I do not think eliminating combination products is necessary and that the vote to do so goes too far," noted Dr. Randy Wexler, assistant professor of clinical family medicine at the Ohio State University Medical Center. "Combination products, especially in caring for patients with chronic pain, are important."

Panel Suggests OTC Acetaminophen Combos Remain Available

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.

Black Box May Be Imminent for Acetaminophen

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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