Liver Damage From Opioid/Acetaminophen Combination Products

Opioid/Acetaminophen Combination Products
A few days ago CNN reported on the FDA's recommendation that physicians stop prescribing pain medication that contain more than 325mg of acetaminophen.

Acetaminophen is commonly found in over the counter medication, the most popular is Tylenol. Acetaminophen is also combined in many prescription products, usually opioids, for example codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).

To reduce the risk of liver damage, in 2011 the FDA asked drug manufacturers to limit the amount of acetaminophen in prescription medication, which were predominantly opioid products; to no more than 325 milligrams(mg) of acetaminophen in each tablet or capsule.  The FDA also required manufacturers to update labels warning consumers of the potential risk for severe liver injury.

Although, over the counter acetaminophen products were not affected by the FDA's action, in the fall of 2011 new dosing instructions for TYLENOL were put in place by Johnson & Johnson. The maximum daily dose was changed from 8 pills (4,000 milligrams) per day to 6 pills (3,000 milligrams) per day. The drug company also changed the dosing interval from every 4-6 hours to every 6 hours.

An update from the FDA was issued this past January asking health care professionals to stop prescribing and dispensing painkillers that exceed 325 mg of acetaminophen. In the same release, the FDA reported 50% of manufacturers followed the FDA's request to lower acetaminophen, moving forward the FDA will begin proceedings to withdraw approval of any drug products that still remain on the market containing too much acetaminophen.

Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much. In an effort to improve regulation of OTC products the FDA is holding a public hearing today and tomorrow to obtain information and comments from consumers. 

Hepatitis C And Acetaminophen
Generally experts agree low dosages of acetaminophen can safely be used in most patients with chronic hepatitis C infection. According to the Veterans Affairs website (updated July 30, 2013) the maximum recommended dose of acetaminophen (Tylenol®) for patients with hepatitis C is two grams or (four 500mg tablets) per day, but people with cirrhosis should use only one gram or two 500mg tablets per day. It goes without saying, people who actively consume alcohol should avoid taking acetaminophen altogether.

Of Interest

Cirrhosis - Warning About NSAIDS
According to this publication by the University of Michigan health System, patients with cirrhosis should avoid pain medications called “non‐steroidal anti‐inflammatories (NSAIDS)” which include over‐the‐counter medications such as ibuprofen (Motrin, Advil), naprosyn (Aleve), as well as some prescription medications.

Additional Reading

March 2014
Acetaminophen Toxicity: What Pharmacists Need to Know
Acetaminophen-induced liver toxicity has become the most common cause of acute liver failure and the second most common cause of liver failure requiring transplantation.10,11 Therefore, it is imperative that pharmacists recognize signs and symptoms of overdose and toxicity, and counsel their patients on proper dosing and usage.

Although progress has been made, some things are still to be determined. The FDA Advisory Committee has voted in favor of many changes thought to improve safety and decrease toxicity, yet the FDA has not yet taken action. For example, while the maximum daily dose of acetaminophen was previously set at 4 g/day, the FDA Advisory Committee suggests decreasing it in an effort to reduce overdoses. It is important to note that some manufacturers have already updated their labeling to reflect these recommendations, although it is not yet mandatory to do so. Efforts are also being made to improve product labeling, enhance patient education, create a universal pediatric formulation, eliminate acetaminophen combination products, and reduce the strength of OTC acetaminophen products to 325 mg per tablet with a maximum single dose of 650 mg. While no final consensus on any of these issues has been reached, healthcare providers should educate their patients on the importance of following labeling instructions.......

OTC Drug Dangers You Should Know About
By Dr. Sanjay Gupta
Michael Lynch, MD, medical director of the Pittsburgh Poison Center at the University of Pittsburgh Medical Center, sees many patients who take OTC drugs for something other than their main intended use. “A common one I hear is people taking Tylenol PM just to sleep,” said Dr. Lynch. “But that also has acetaminophen in it; and if you’re taking too much, it can lead to toxicity.”

How to protect your liver when taking prescription and over-the-counter medications, herbal remedies or other drugs
The liver is the body's clearinghouse for most drugs, herbal remedies, vitamins and supplements which means it is vulnerable to the toxic consequences of inadvertent overdoses, unexpected interactions or extended use. View the following tips to help safeguard your liver health and ensure that the medications and remedies you need to take achieve their desired effect......

Bottom Line
The FDA reported;  most cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products. 

Make sure you take your prescription and over-the-counter (OTC) medicine properly, read the package insert or label in order to calculate your daily intake of acetaminophen.  As mentioned, remember that many narcotic combination pills and over-the-counter cold and flu medications contain acetaminophen.

For important information check out; KnowYourDose.org., a website ran by the Acetaminophen Awareness Coalition, which offers information on some 600 medications that contain acetaminophen.

While you're there play the "Game of Life" and test your "Acetaminophen Knowledge." 

Stay healthy!
Tina