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Pain Management Health Center

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Acetaminophen Safety: FAQ

Questions and Answers About Acetaminophen, Liver Damage Risk, and the FDA

What did the FDA advisory committees recommend? continued...

Here are the measures that the FDA advisory committees did not recommend:

  • Limit pack sizes for over-the-counter acetaminophen products: 17 yes votes, 20 no votes. The yes votes include two committee members who said this should be a high priority.
  • Eliminate over-the-counter products that combine acetaminophen with other drugs: 13 yes votes, 24 no votes. The yes votes include two committee members who said this should be a high priority.

For more on the FDA advisory committee vote, and reactions from the drug industry, read WebMD's news story, filed on the day of the committee vote.

Are those recommendations now in effect?

No. FDA advisory committees make recommendations, but they don't set policy. That's the FDA's job.

The FDA has the final word on how to handle acetaminophen. The FDA often follows the advice of its advisory committees, but it's not required to do so. It could accept some, all, or none of the recommendations.

When will the FDA make its decision on acetaminophen?

There is no set deadline for the FDA to do that. It could take months. When the FDA acts on acetaminophen, WebMD will cover that news.

How can I take drugs containing acetaminophen safely?

The key with acetaminophen -- or any other drug -- is to take it exactly as instructed by your doctor or the drug label. Taking too much, even a little too much, is risky, even if you didn't need a prescription to get it.

Here are some specific tips from the FDA's web site:

  • Read all the information given to you by your doctor and follow directions.
  • Follow directions on the "Drug Facts" label of over-the-counter products.
  • Be sure you understand the dose (how much acetaminophen you can take at one time), how many hours you must wait before taking another dose of acetaminophen, how many doses of acetaminophen you can take safely each day, and when to stop taking acetaminophen and ask a doctor for help.
  • Never take more than directed, even if your pain or fever isn't any better.
  • Never take more than one medicine that contains acetaminophen.
  • Check the active ingredients of all your medicines to make sure you're taking no more than one medicine containing acetaminophen at a time.
  • Know that some prescription drug labels may abbreviate acetaminophen as "APAP." The same precautions still apply.
  • Talk to your doctor before taking acetaminophen if you drink alcohol, have liver disease, or take the blood thinner warfarin.

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