FDA panel backs ban on painkillers

Here's a ban that could be a real pain for drugmakers: An FDA advisory panel voted in favor of pulling the narcotic combo drugs Percocet and Vicodin, seven other acetaminophen/narcotic combos, and all their generic equivalents. It's not the narcotic portion of the drugs the experts are worried about, though. It's the acetaminophen, a.k.a. Tylenol, which can be toxic to the liver.

The panel also voted that recommended doses for regular old Tylenol be reduced, and that the extra-strength versions be sold by prescription only.

Say what? Isn't Tylenol billed as one of the safest drugs in the world? Yes, but acetaminophen is also a leading cause of liver injury and has been for more than 10 years, FDA says. And now that there's a new drugs sheriff in town, those risks are getting another look. "The reality is we've known for some time that Tylenol plus alcohol is potentially damaging to livers, and we've also known that way too much is damaging to livers," pharma analyst Les Funtleyder of Miller Tabak & Co. told Bloomberg. "It's not a huge surprise."

Still, banning those drugs would be a huge change. Vicodin, sold by Abbott Laboratories, and its copycats are the most popular drugs in the U.S., accounting for more than 100 million scrips last year, the New York Times reports. Many patients still think of acetaminophen as a super-safe med. And doctors are accustomed to handing out scrips for one of these combo narcotics post-surgery, post-trauma, and so on. Not to mention the average, everyday use of acetaminophen-containing meds for headaches, fevers, colds and the like. "Whatever we do on any of these options, it will really affect the whole health-care system," Gerald Dal Pan, director of the FDA's office of drug surveillance, told the Wall Street Journal. Indeed.

But pain-management experts point out that the narcotic portions of the painkillers and the acetaminophen can be prescribed separately. Let's see what the agency decides.

- read the NYT story [1]
- check out the coverage [2] from Bloomberg
- get the WSJ piece [3]

Related Article:
FDA: Tougher warnings, dose limits for Tylenol [4]