Consumer Alert: Stronger Warning Urged for Popular Painkiller

A Food and Drug Administration report released Wednesday recommends stronger warnings and dose limits on drugs containing the painkiller acetaminophen, citing an increased risk of liver injury.

The recommendation covers both prescription doses and over-the-counter medication, of which Johnson & Johnson's Tylenol is the most well-known. Acetaminophen is also widely available as a generic over-the-counter drug.

"There is extensive evidence that hepatotoxicity (liver toxicity) caused by acetaminophen use may result from lack of consumer awareness that acetaminophen can cause severe liver injury," the working group report said.

The outside advisers will meet in June to discuss the report's findings. The recommendations include enhanced public information efforts, stronger labels warning of liver side effects, and dose limitations.

"Consumers may not be aware that acetaminophen is present in many over-the-counter combination products, so they may unknowingly exceed the recommended acetaminophen dose if they take more than one acetaminophen product without knowing that both contain acetaminophen," the report said.

The recommendations also call for limiting the maximum adult daily dose to no more than 3,250 milligrams, limiting tablet strength for immediate release formulations, and limiting options in liquid formulations for children.

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  • by Anonymous on May 28, 2009 at 06:23 AM
    Almost every medication can cause damage to various organs
  • by RPH Location: LANSING on May 27, 2009 at 11:09 PM
    Almost all the dumb doctors in lansing prescribe Vicodin ES. Which has the highest levels of Acetaminophen of any prescription pain killer. You would think as pharmacist try to make them aware of the danger they would appreciate it. Instead, I constantly run into doctors who refuse to use a safer, just as effective pain killer with the same narcotic but about 30 to 60% less acetaminophen. Tell your friends, tell your doctors to stop writing for Vicodin ES. Norco and lortab have the same amount of narcotic pain reliever, just less acetaminophen. Thus you can take the dose you need (and that they want to prescribe) with a much lower chance of liver failure. Lived in this state over 7 years and have yet to have a physician switch or say thank you when I recommend those alternatives. Some of my patients listen and get their dr to switch them. PS-all are available in generic so I am not pushing for a more expensive alternative. Just safer.
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