FDA Committee Recommends Pulling Vicodin, Percocet

First an FDA panel went after Darvon (Darvocet, propoxyphene).

Now, an FDA committee has MUCH bigger targets in its sights—Vicodin and Percocet.

An FDA advisory committee just finished two days of meetings regarding the safety of acetaminophen (generic name for Tylenol) and your liver. Their two recommendations to the FDA?

ONE: Lower the recommended daily intake of acetaminophen. Currently, that amount is 4 grams, or 4000 milligrams. This amount is supposed to be safe even for people with various liver problems. Now, in terms of regular Vicodin 5/500 (hydrocodone, Lortab), that's 8 per day, since the regular strength of these meds each has 500 mg of acetaminophen. Percocet 5/325 contains less acetaminophen (325 mg), while Darvocet contains the most (650 mg).

TWO: Pull widely used opioid painkillers such as Vicodin and Percocet because of their acetaminophen content.

Do they have any idea how many people—including patients with lymphomas and other cancers—rely on short-term opioids like Vicodin and Percocet? Goodness, the number is enormous.

Fortunately, this is merely a recommendation. A larger FDA body has to approve it, and personally I don’t think it's likely. I also don't think it's likely that the amount of acetaminophen that goes into Vicodin or Percocet will be lowered, since that will make abuse much more attractive. At any rate, hydrocodone can be prescribed with higher narcotic content and lower acetaminophen content, in such combinations as Norco 10/325.

You can read the FDA's Q & A on acetaminophen and liver injury HERE.

You can read about the two-day meeting itself HERE.