FDA won't ban combo painkillers, but adds controls

FDA has issued an ultimatum to makers of combination painkillers such as Percocet and Vicodin. The agency won't ban the drug as an advisory panel recommended in 2009, the New York Times reports, but will restrict the amount of acetaminophen--the active ingredient in Tylenol--allowed in each combo pill. Drugmakers get three years either to reformulate their products or to stop making them altogether.

Combination painkillers have been under FDA scrutiny for some time, because acetaminophen can cause liver damage--and worse--when taken to excess. Some patients don't realize that their pain pills contain the same ingredient as Tylenol, the agency says, and so they pop over-the-counter painkillers on top of their prescription drugs. Plus, some people are more vulnerable to liver damage from acetaminophen and react badly even to recommended doses.

The FDA's expert advisors recommended banning the pain drugs that combine acetaminophen with opioids such as codeine and oxycodone, and they advised pulling extra-strength over-the-counter acetaminophen products, too. So far, there's no ban on either, but the FDA will limit acetaminophen content in combo drugs to 325 mg per pill, less than half the current number, and require more explicit labeling. "[W]e thought this was a more reasonable action to take and one that would not cause disruption," Sandra Kweder told Bloomberg. More moves may be ahead, officials told the NYT.

- see the FDA release
- read the Times piece
- get more from the Wall Street Journal
- check out Bloomberg's coverage

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