Monday, November 4, 2013

AASLD-Label Warnings Not Enough to Protect Consumer Safety When Taking Acetaminophen

Tylenol and Alcohol a Bad Mix, Study Suggests

Taking the recommended dose of Tylenol, also known by its generic name acetaminophen, combined with a small to moderate amount of alcohol produces a 123 percent increased risk of kidney disease, according to a new preliminary study.

"Most people take this medication without any input from pharmacists or physicians, and that's where the public-health concern is," said lead researcher Harrison Ndetan, an associate professor for research and biostatistics at Parker University in Dallas. "People buy acetaminophen over the counter, and they also are casual alcohol users, and they don't know that there is a harmful interaction."

The study, scheduled for presentation Monday at the American Public Health Association's annual meeting in Boston, establishes only an association between an acetaminophen-and-alcohol combination and increased risk for kidney disease, not a direct cause-and-effect relationship.

Chronic acetaminophen use and chronic alcohol abuse both have been separately linked to kidney and liver disease, said Dr. Martin Zand, medical director of the kidney and pancreas transplant programs at the University of Rochester Medical Center in New York.

"What has not been well-studied until now is the link between some regular alcohol use and regular acetaminophen use and increasing your risk of kidney disease above the risk of either of those used separately," said Zand, who was not involved in the new research.

For the study, researchers analyzed data from more than 10,000 people who participated in the 2003-04 U.S. National Health and Nutrition Examination Survey. It included questions about alcohol consumption, use of acetaminophen and health problems.

The study found that neither normal use of acetaminophen nor light to moderate drinking posed a potential threat to kidneys.

Nearly half of the people who combined the two, however, reported health problems related to their kidneys, the researchers said. Specifically, of the 2.6 percent who took the combination, 1.2 percent reported kidney dysfunction. 

Alcohol can interfere with the gene that regulates the way the body processes acetaminophen, Ndetan said, adding that this is the most likely potential explanation for the association found in the study.

The warning label included on acetaminophen packaging does say not to take the medication with alcohol, Ndetan said, "but it is important for people to receive this message because people will take them despite those warnings."

It's not known if similar interactions occur with other painkillers, he said.

In general, people who regularly consume one should not use the other, Zand said.

If you take acetaminophen daily for chronic pain, you should avoid alcohol, he said. If you drink alcohol regularly, you should try another painkiller or avoid over-the-counter pain medications altogether.

"I'm not suggesting people should not use acetaminophen and should not appropriately and modestly consume alcohol," Zand said. "But it's not a good idea to take acetaminophen for a number of days in a row and then drink alcohol."

So what about taking acetaminophen for a hangover?

"If you do need to take something for pain and if you are not a regular drinker, it would seem to be OK to take some acetaminophen for it," Zand said. "Assuming your kidneys are fine, you might want to choose another painkiller if you want to err on the side of caution, because you've just put your liver through a stress test and it needs all the breathing room it can get to recover."

Research presented at meetings is typically considered preliminary until published in a peer-reviewed medical journal.

AASLD Press Release

Label Warnings Not Enough to Protect Consumer Safety When Taking Acetaminophen

Acetaminophen is the leading cause of acute liver failure in the US. In January 2011, the Federal Drug Administration asked manufacturers to limit the strength of acetaminophen in prescription drug products. They also requested a Boxed Warning for severe liver injury to be added to the label of all prescription drug products that contain acetaminophen. The American Association for the Study of Liver Diseases (AASLD) has been a long-time proponent of these and other measures to improve the safety of acetaminophen, which if used properly, is a safe and effective drug.

Researchers from Northwestern University and Emory University concluded in a recent study that use of an enhanced icon on medication labels and additional written information were insufficient in ensuring the safe use of acetaminophen products. The study of enhanced communication strategies between healthcare providers and patients was conducted between August 2012 and February 2013. Patients at the general medicine clinics were either provided the usual care; provided enhanced bottle labeling with an with an icon identifying acetaminophen as an active ingredient and a flyer to explain safe use of the product (written strategy); or enhanced labeling, written brochure, and added verbal counseling (written and verbal strategy).

Patients in either of the enhanced information groups (written, written and verbal) were more likely to identify acetaminophen as an active ingredient. Only the verbal counseling strategy improved the understanding of the risk of concomitant use with other acetaminophen-containing products. Neither strategy improved understanding to greater than 50 percent. According to Marina Serper, MD, "The strategies we used were supposed to simulate what a patient may encounter in a typical pharmacy when picking up a prescription or choosing an over-the-counter product. We were somewhat surprised that these strategies improved comprehension but not to levels above 50 percent."

The study concluded that additional public health measures are needed to ensure the safe use of acetaminophen. "Acetaminophen is widely prescribed and is available in multiple over the counter products," said Dr. Serper. "Results of this study highlight the public's lack of knowledge of the potential dangers of acetaminophen and that broader public health campaigns may be needed to raise public awareness."

Dr. Serper also had some comments for healthcare providers, "We recommend that healthcare professionals routinely obtain detailed medication histories from their patients, counsel them on the maximum safe daily dose of acetaminophen, and the risks of combining multiple
acetaminophen-containing products."

Abstract title:
Effect of Enhanced Risk Communication on Patient Comprehension of Concomitant Use Warnings for Acetaminophen-Containing Products: A Randomized Trial


AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in Washington, November 2-5, will bring together more than 9,000 researchers from 55 countries.

A pressroom will be available from November 1 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.

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