Skip to main content
Advertising

Originally published January 15, 2014 at 7:35 PM | Page modified January 16, 2014 at 1:14 PM

  • Share:
           
  • Comments (21)
  • Print

FDA asks doctors to stop prescribing high-dose acetaminophen

Citing the risk of liver failure, the Food and Drug Administration has asked health-care professionals not to give patients more than 325 mg of acetominophen when the pain reliever is combined with drugs like Codeine, Percocet or Vicodin.


Los Angeles Times

Most Popular Comments
Hide / Show comments
Acetaminophen is a dangerous drug - often combined by non-educated people with... MORE
This has been far too long in coming; go to the medical library and see for yourself. MORE
In the UK, paracetamol (acetaminophen) is over-the-counter, but better regulated. The... MORE

advertising

LOS ANGELES — The Food and Drug Administration (FDA) has asked doctors, dentists, pharmacists and other health-care professionals to stop giving patients high-dose acetaminophen, the active ingredient in the popular pain-reliever Tylenol.

Pills, capsules, tablets, syrups and other formulations that contain more than 325 milligrams of acetaminophen have not been shown to reduce pain better than lower doses of the medication; however, such high levels of the drug can cause liver damage, the FDA explained in a recommendation issued Tuesday.

One of the most commonly used drugs in the country, acetaminophen helps with pain and fevers.

Pharmacists who are asked to fill prescriptions for medications with more than 325 mg of acetaminophen should contact the doctor or dentist who ordered it and see if a lower dose would suffice, the recommendation said.

The warning may surprise people who take Tylenol Extra Strength, for instance, which can contain 500 milligrams of the drug in each tablet. But the FDA is focusing on acetaminophen-combination drugs that require prescriptions like Tylenol with Codeine, Percocet and Vicodin.

The FDA has warned consumers about the risk of inadvertent overdoses of acetaminophen, which can happen when people simultaneously take several drugs that contain the painkiller.

Reducing the maximum dose of acetaminophen should also reduce the risk of an accidental overdose, since nearly half of such cases involve a prescription medication, the FDA said.

Patients who have too much acetaminophen in their systems can suffer liver failure, since that organ is responsible for metabolizing the drug.

As explained by Harvard Medical School’s Family Health Guide, most acetaminophen is broken down into harmless substances that are removed from the body in urine. “But a small percentage is rendered into a compound that’s extremely harmful to cells,” the guide says.

The compound is known by the acronym NAPQI, and it’s combined with an antioxidant called glutathione to make it safe to ingest. But in the case of an overdose, there’s “not enough glutathione to sop up NAPQI,” making liver damage a threat.

Three years ago, FDA regulators asked drug manufacturers to voluntarily reduce the amount of acetaminophen in powerful medicines like Percocet and Vicodin that also contain opioids or other painkillers. Physicians and dentists typically prescribe these drugs to patients after surgery, serious injuries or dental procedures.

The FDA had set a target date of Jan. 14, 2014. As of Tuesday, more than half of the manufacturers contacted had complied with the request, according to the agency. Regulators will take steps to withdraw their approval of drugs containing more than 325 mg of acetaminophen “in the near future,” according to the statement.

Acetaminophen is also an extremely popular over-the-counter drug. Both Tylenol and generic versions are used to treat pain and fevers, and they are also combined with cough and cold medicines. Some of the over-the-counter brands that include acetaminophen include Benadryl, Excedrin, Nyquil, Robitussin, Theraflu and Vicks, according to the Acetaminophen Awareness Coalition.



News where, when and how you want it

Email Icon

The summer is wide open.

The summer is wide open.

Follow our three-part "Washington's National Parks" series running through August 10 for an in-depth look at some of our local treasures.

Advertising

Partner Video

Advertising


Advertising
The Seattle Times

The door is closed, but it's not locked.

Take a minute to subscribe and continue to enjoy The Seattle Times for as little as 99 cents a week.

Subscription options ►

Already a subscriber?

We've got good news for you. Unlimited seattletimes.com content access is included with most subscriptions.

Subscriber login ►