Overuse of acetaminophen, the active ingredient in over-the-counter pain relievers like Tylenol and Excedrin, is one of the leading causes of acute liver failure in the U.S, resulting in an estimated 56,000 emergency room visits, 26,000 hospitalizations and nearly 500 deaths a year. Most of that overuse is unintentional, the result of unwitting consumers taking both acetaminophen and a common cold medication that also contains acetaminophen (like Nyquil). 

In April, the FDA required manufacturers to include stronger warnings on the labels of acetaminophen-containing products. But today, the agency's drug safety advisory committee will consider what additional steps the agency should take to protect consumers from unwittingly poisoning themselves by double-dosing on acetaminophen. One of the major proposals on the table: Prohibit companies from marketing combination products.

Strong industry opposition makes it unlikely the advisory committee or the agency will go that far. If the advisors endorse less drastic measures, what might they be? This is an important first test of the FDA's new power to impose risk evaluation and mitigation strategies (REMS) on manufacturers of widely used drugs that pose a small but distinct public health threat when misused or abused. Can industry and the agency come up with something short of banning the combination products that will actually reduce the incidence of acute liver failure? It will be interest to see what they come up with.