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Acetaminophen Safety: FAQ

Questions and Answers About Acetaminophen, Liver Damage Risk, and the FDA
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What was the FDA advisory committee meeting about? continued...

Those options that the committees considered are as follows:

  • Lower the maximum total daily dose in over-the-counter products.
  • Limit the maximum single dose for adults taking over-the-counter products.
  • Switch the current maximum dose of acetaminophen to prescription status.
  • Limit pack sizes for over-the-counter acetaminophen products.
  • Eliminate over-the-counter products that combine acetaminophen with other drugs.
  • Make only one concentration of nonprescription liquid acetaminophen available.
  • Eliminate prescription drugs that combine acetaminophen with other drugs.
  • Require certain packaging changes for prescription drugs that combine acetaminophen with other drugs.
  • Require a "black box" warning (the FDA's sternest warning) for prescription medicines that combine acetaminophen with other drugs.

 

What did the FDA advisory committees recommend?

Here are the measures that advisory committees voted to recommend to the FDA:

  • Lower the maximum total daily dose in over-the-counter products: 21 yes votes, 16 no votes. The yes votes include 11 committee members who said this should be a high priority.
  • Limit the maximum single dose for adults taking over-the-counter products: 24 yes votes, 13 no votes. The yes votes include 12 committee members who said this should be a high priority.
  • Switch the current maximum dose of acetaminophen to prescription status: 26 yes votes, 11 no votes. The yes votes include eight committee members who said this should be a high priority.
  • Make only one concentration of nonprescription liquid acetaminophen available: 36 yes votes, 1 no vote. The yes votes include 19 committee members who said this should be a high priority.
  • Eliminate prescription drugs that combine acetaminophen with other drugs: 20 yes votes, 17 no votes. The yes votes include 10 committee members who said this should be a high priority.
  • Require certain packaging changes for prescription drugs that combine acetaminophen with other drugs: 27 yes votes, 10 no votes. The yes votes include five committee members who said this should be a high priority.
  • Require a "black box" warning (the FDA's sternest warning) for prescription medicines that combine acetaminophen with other drugs: 36 yes votes, 1 no vote. The yes votes include 25 committee members who said this should be a high priority.

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