Too Much Of A Good Thing

Photo Credit – Wikipedia

 

# 6714

 

Today we’ve a bit of a follow up to a blog I wrote last month called The Narrow Margin that looked at the dangers of accidental overdosing with acetaminophen (APAP) which is an ingredient found in more than 600 prescription, and non-prescription, drugs.

 

While well tolerated and safe at normal doses, too much acetaminophen can cause liver damage, and even death. The maximum safe dose for an adult under 65 is considered to be 4g in 24 hours (3g for those over 65, or those with liver problems).

 

In October the AAC  (Acetaminophen Awareness Coalition) launched a Know Your Dose campaign to help educate consumers about the safe use of the popular pain reliever.

 

Credit – Acetaminophen Awareness Coalition

 

The problem goes beyond the public’s mixing and matching over-the-counter medications, as some doctors will typically prescribe  hydrocodone/APAP 5 mg/500 mg 1 to 2 tablets every 4 to 6 hours to give patients some latitude in pain control.

 

If a patient takes the full prescribed dose (12 pills in 24 hours) they will ingest 6 g of acetaminophen, or 50% more than the maximum daily recommendation.

 

In 2011 the FDA announced their intention to limit the amount of acetaminophen in opioid/APAP prescriptions like Vicodin and Lorcet to 325mg in order to reduce the risk of liver damage in patients taking these meds for chronic pain. 

 

Those regulations won’t come into effect until January of 2014, and for now, 500 mg & 600 mg APAP/opioid analgesics are common.

 

Which brings us to a study today in the Archives Of Internal Medicine called:

Supratherapeutic Dosing of Acetaminophen Among Hospitalized Patients

Li Zhou, MD, PhD; Saverio M. Maviglia, MD, MS; Lisa M. Mahoney, RPh; Frank Chang, MSE; E. John Orav, PhD; Joseph Plasek, MS; Laura J. Boulware; Hong Lou; David W. Bates, MD, MSc; Roberto A. Rocha, MD, PhD

Arch Intern Med. 2012;():1-8. doi:10.1001/2013.jamainternmed.438.

 

 

This study, which looked at the records of more than 23,000 patients at two Boston hospitals during the summer of 2010, and found that 14,411 patients during the study period were administered acetaminophen.

 

Nearly a thousand of those (n=955, or 6.6%) received more than the the 4g daily maximum dose.  Perhaps even more telling, 22.3% of patients older than 65, and 17.6% of patients with chronic liver disease exceeded the 3g/day limit.

 

No cases of liver toxicity were reported among these patients, although some patients did experience significant elevations of at least one liver enzyme (alkaline phosphatase). The authors caution, however, that a `causal relationship cannot be concluded’.

 

Patients receiving more than one acetaminophen containing drug, and those in surgical and intensive care units, were most likely to exceed the daily maximum dosage of APAP.

 

All of which shows that, even in a hospital setting, it is all too easy to exceed the 4 g/day APAP maximum dose.

 

The phasing in of lower APAP levels in opioid-combo  analgesics over the next year should go a long ways towards reducing this problem, as would better health information technology systems designed to catch such overdoses, and alert the nursing staff.

 

Until then (and even after) it is always a good idea to be proactive and ask what meds you (or someone in your care) is being given in a hospital, and to speak up if you suspect their might be a problem.

 

For more on this story, you may wish to check out this report from Reuter’s Health.

 

Many hospital patients get too much Acetaminophen

By Genevra Pittman

NEW YORK | Tue Nov 13, 2012 12:36pm EST

The Narrow Margin

Photo Credit – Wikipedia

 

# 6649

 

 

Cold and flu season is upon us, and that means the consumption of over the counter (OTC) remedies will go up considerably over the next few months. So each fall I try to do a piece on some of the hidden dangers of these commonly used medications.  

 

• Last year, in Kids, Colds, And OTC Meds we looked at the continuing trend of parents – against the advice of the CDC  – to use OTC medications to treat cold and flu symptoms in toddlers under the age of four.

 

• And the year before, we looked at inconsistent and confusing dosing instructions provided by many manufacturers of OTC medications (see JAMA: Inconsistent Dosing Instructions For OTC Meds).

 

• Another study in 2010 (see Inappropriate Use Of OTC Medicines In Children) reported that inappropriate use, and incorrect dosing of OTC meds lead to a large number of accidental drug poisonings each year.

 

 

The plain truth is, accidental and intentional poisonings from OTC medications are very common.

 

A study published last year in the American Journal of Preventive Medicine (see Emergency Department Visits for Overdoses of Acetaminophen-Containing Products) found that - in the United States alone – there are an estimated 78,414 ER visits each year due to acetaminophen (aka Tylenol, paracetamol, APAP) poisoning.

 

While most of these were intentional overdoses (69.8%), more than 13,000 ER visits were described as due to `therapeutic misadventures’  . . . or accidental overdoses.

 

The problem with acetaminophen is that there is a narrow margin between the maximum therapeutic dose and a potentially toxic (and sometimes fatal) overdose. 

 

While well tolerated when taken as directed, APAP in larger doses is a hepatotoxin; it overwhelms and destroys the liver. In fact, APAP poisoning is the biggest cause of acute liver failure in the United States (cite).

 

Since more than 600 products (OTC and Rx) contain acetaminophen, many consumers may be unaware that they could be `doubling up’ their dose when they take two or more of them. 

 

All of which leads me to a press release issued earlier this week by the AAC  (Acetaminophen Awareness Coalition)  who have launched a Know Your Dose campaign to help educate consumers about the safe use of acetaminophen. 

 

Excerpts below, but follow the links to read them in their entirety.

 

Credit – Acetaminophen Awareness Coalition

 

 

U.S. Health Coalition Reminds Consumers: Double Check, Don't Double Up

As Cold and Flu Season Nears, Consumers Are Urged to Double Check Their Medicine Labels to Avoid Doubling Up on Acetaminophen

WASHINGTON, Oct. 17, 2012 /PRNewswire-USNewswire/ --

The Acetaminophen Awareness Coalition is launching a nationwide initiative today calling on consumers to double check their medicine labels so they don't double up on medicines that contain acetaminophen during the cold and flu season. Acetaminophen is the most common drug ingredient in America. It is found in more than 600 different medicines, including prescription (Rx) and over-the-counter (OTC) pain relievers, fever reducers, sleep aids and numerous cough, cold and flu medicines. It is safe and effective when used as directed, but there is a limit to how much can be taken in one day. Taking more than directed is an overdose and can lead to liver damage.

 

Each year, Americans catch an estimated one billion colds, and as many as 20 percent get the flu. Seven in 10 consumers use over-the-counter medicines, many of which contain acetaminophen, to treat their symptoms. The Coalition is targeting its "Double Check, Don't Double Up" message to the more than 50 million Americans who use acetaminophen weekly for conditions such as headache and chronic pain, and directing them to double check their medicine labels before taking a cold or flu medicine that also contains acetaminophen.

 

<SNIP>

When taking medicines for cough, cold or flu this coming season, consumers should follow these four simple acetaminophen safety steps:

1. Know if medicines contain acetaminophen, which is in bold type or highlighted in the "active ingredients" section of over-the-counter medicine labels and sometimes listed as "APAP" or "acetam" on prescription labels.
2. Never take two medicines that contain acetaminophen at the same time.
3. Always read and follow the medicine label.
4. Ask your healthcare provider or a pharmacist if you have questions about dosing instructions or medicines that contain acetaminophen.

(Continue . . . )

 

For more on this issue, we turn to the FDA’s  Youtube channel for the following videos.

 

 

 

 

 

 

While drugs like acetaminophen are extremely useful and safe when taken as directed, the number of ER visits each year testify to the harm they can do when taken inappropriately.