10 takeaways from ProPublica's acetaminophen (Tylenol) investigation

Kathleen Blanchard's picture
Acetaminophen (Tylenol) investigation: What consumers should known
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Consumers know Tylenol, or acetaminophen can relieve pain and reduce fever. They also know it is widely used in hospitals and marketed as safe. But a recent report from ProPublica has found we don’t know enough about the dangers of the drug that sends 78,000 Americans to the emergency room each year. What can consumers learn about medication safety?

The FDA boosted warnings for acetaminophen, calling the potential health hazards a “persistent, important public health problem.”

One of the newest FDA warnings is that acetaminophen can cause severe allergic reaction known as SJS or Stephens-Johnson-Syndrome that can be life-threatening.

The purpose of the recent news about the drug is to educate consumers rather than cause alarm.

Consumers are often unaware that many other over-the-counter ,and prescription drugs too, contain the active ingredient in Tylenol.

The medication is used regularly in hospitals to treat pain and fever. Research shows acetaminophen can also help calm anxiety, making it useful – as long as it is used properly by consumers.

Amanda Zamora, a ProPublica investigator, asks how Tylenol became one of America’s top pain relievers, given the multiple risks, which also include liver damage and failure in high doses and for those who are susceptible from pre-existing liver abnormalities and particularly in combination with alcohol.

Has enough been done to educate consumers?

According to the press release, “…federal regulators delayed or failed to adopt measures designed to reduce the rising number of deaths and injuries from acetaminophen; …McNeil, while it undeniably took steps to protect consumers, also fought repeatedly against safety warnings, dosage restrictions and other protective measures.”

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According to the group, the FDA and the drug manufacturer have both been aware there is a slim margin between the amounts of Tylenol we can take that is safe and the amount that can cause harm, including death, is much slimmer than other pain relievers – yet it took 32-years to put a warning on the medication about risk of “severe liver failure”.

The FDA has continued to delay proposals for making acetaminophen safe per this 2009 document.

In statements, McNeil told ProPublica: “McNeil takes acetaminophen overdose very seriously, which is why we have taken significant steps over the years to mitigate the risk,” which indeed they have – though the company did not respond to questions about individual deaths and injury from taking Tylenol.

The group has offered 9 steps the FDA and the manufacturer could take to mitigate the harm from the drug, one of which is that death can occur from overdose.

Taking 25 percent more of the recommended dose can result in liver damage, that is a concern. According to the FDA, one-fourth of Americans take more than the maximum recommended amount, which is no more than 4 Grams a day, or 8 extra strength capsules or tablets.

If you have a story about acetaminophen causing harm, ProPublica would like you to share it here.

Nyquil, narcotic pain relievers such as codeine and oxycodone all contain acetaminophen, making it easier for consumers to err when estimating how much of the drug they are taking.

Here is another story from a man who took Tylenol as recommended and ended up needing a liver transplant within days. At the time, there was no warning about the risk of combing acetaminophen with alcohol.

10 takeaways from the Tylenol investigation

  1. Consumers should always read medication labels and take them seriously, regardless of what type of drug – prescription or over-the-counter.
  2. If you take other medications, such as blood thinners, understand that acetaminophen can increase your risk of bleeding. It doesn’t mean you can’t take the medication, but speak with your doctor about monitoring (for instance for those taking warfarin or Coumadin).
  3. Start with the lowest dose of any pain medication. If you are unsure if a medicine is right for you, take advantage of your pharmacist’s knowledge and ask for counseling.
  4. Understand that all medications have side effects. Never assume. If your health changes or worsens in any way after starting a medication, call your doctor.
  5. Try alternative therapies whenever possible. Use any over the counter medication for the shortest time needed until your health improves. Fever, pain and other ailments are the body’s way of telling you there is an underlying problem that should be diagnosed.
  6. Know your numbers. Be a savvy healthcare consumer and take advantage of your preventive blood tests that are now part of Obamacare. A simple blood test can check your liver enzymes and more. All medications are filtered either through the liver, kidneys or both. If you take multiple medications, you may be at higher risk for harm from acetaminophen.
  7. Avoid the need to take medications by practicing a healthy lifestyle and being kind to your body. Wash your hands frequently during cold and flu season. Eat a variety of foods that can help boost immunity and quell inflammation.
  8. Don't mix medications of any sort with alcohol.
  9. Understand that herbs and vitamins can interact with prescription and over-the-counter medications. Kava has been linked to liver damage and ibuprofen combined with gingko biloba can cause internal bleeding.
  10. Follow directions for dosing of acetaminophen in children to the letter. Here is a handy chart that tells you how much Tylenol your child can take from St. Louis Children's Hospital.

Acetaminophen or Tylenol is not a benign drug, highlighted by recent FDA warnings and an independent investigation. Consumers can remain safe by reading dosing and warnings on any medication. Don't mix medicines and also speak with your doctor or seek immediate help if your condition changes. Take time to learn what other drugs contain acetaminophen by reading labels.

Image credit: Wikimedia Commons

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