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FDA Restricts Acetaminophen In Popular Pain Medications

This is a guest post from Dr. Mary Lynn McPherson.

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FDA Restricts Acetaminophen In Popular Pain Medications

The Food and Drug Administration (FDA) made an announcement yesterday that affects one of the most common pain medications on the market, and as a consequence may affect countless numbers of the 75 million Americans who experience chronic pain (for perspective, that’s more than the number of people suffering from cancer, heart disease and diabetes combined.) The FDA has asked manufacturers of popular prescription pain medications like Vicodin or Percocet to limit the amount of acetaminophen (also known as Tylenol, or APAP) used in these drugs to no more than 325 milligrams per tablet — the equivalent of one regular-strength Tylenol tablet.

The move came because research has shown that acetaminophen can cause liver damage when taken in higher than recommended doses. The problem is that many over-the-counter medications ALSO contain acetaminophen, and patients may take one or more of these common products (like Tylenol) to reduce their fever or get rid of a headache along with their prescription pain relievers.

Before you know it, you could be taking more than the maximum daily dose of acetaminophen which is 4,000 milligrams. I go out of my way to advise people I work with of this warning, but not everyone takes time to talk to the pharmacist and not all pharmacists make themselves readily available. That is why it is critically important that you talk to your pharmacist to make sure that you are not taking more than this amount. The pharmacist is the last stop between you and medication misuse — you could be taking a medication that contains acetaminophen and not even know it.

There is more good news from the FDA, as it is also requiring manufacturers to strengthen warnings to doctors about overprescribing acetaminophen. Based on research showing that almost half of accidental acetaminophen overdoses are due to these pain medications, it is critical that doctors and patients know the risk factors: Patients who take more than 4,000 milligrams of acetaminophen in a 24-hour period, patients who take more than one medication containing acetaminophen, and patients who drink alcohol while taking acetaminophen (even while taking less than 4,000 mg of acetaminophen per day). Severe liver injury can lead to liver failure, which can lead to a needed liver transplant or even death.

Pharmacists — the drug experts — offer these guidelines about staying safe while taking acetaminophen:

  • Acetaminophen is a safe drug when taken as directed.
  • Do not take more than 4,000 milligrams of acetaminophen in a 24-hour period. Your pharmacist can tell you how many milligrams are in each tablet or capsule of pain medication you are currently taking.
  • Do not stop taking your prescription pain medication unless told to do so by your doctor.
  • Read all labels for prescription and over-the-counter medications to determine if they contain acetaminophen; your pharmacist can also help you determine this.
  • Do not take more than one medication at a time that contains acetaminophen.
  • Do not drink alcohol while taking acetaminophen.
  • Never take someone else’s medications, particularly pain medications. What is safe for one person may be dangerous for someone else.
  • Never give children an adult-strength tablet or capsule of acetaminophen. Check with your doctor or pharmacist for appropriate doses of acetaminophen for children.
  • Rarely, acetaminophen can cause allergic reactions, so if you experience swelling of the face, mouth, and throat, difficulty breathing, itching, or rash seek emergency help.

Your pharmacist can work with your doctor to suggest pain medications to effectively manage your pain while reducing the risk of side effects. Uncontrolled pain is an epidemic in the United States, but medication safety is first and foremost. The FDA has required that these changes to acetaminophen products happen over the next three years. To learn more about these changes, watch the video below and visit www.fda.gov/acetaminophen.

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Mary Lynn McPherson, PharmD, BCPS, CPE is a Professor and Vice Chair in the Department of Pharmacy Practice and Science at the University of Maryland School of Pharmacy in Baltimore, Maryland. Dr. McPherson works in both hospice and primary care, serving as the Director of Pharmacotherapy Services at the UniversityCare at Waxter Center in Baltimore. She is President of the American Society of Pain Educators and is a fellow of the American Society of Health-Systems Pharmacists and the American Pharmacists Association. She teaches and publishes extensively on pain management and palliative care. Dr. McPherson is also a 2010-2011 fellow with the Mayday Pain & Society Fellowship supported by The Mayday Fund, a New York-based private foundation dedicated to alleviating human physical pain.

Disclosures: None


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