The Enid News and Eagle, Enid, OK

October 3, 2012

Acetaminophen: Take as directed

By Judy Rupp, columnist
Enid News and Eagle

— Julie remembers her mother giving her Tylenol (acetaminophen), and she still thinks of it as the safest pill for treating a headache or bringing down a fever.    

Parents have long been warned against giving aspirin to their children because of an increased risk of Reyes syndrome when aspirin is taken for flu-like illness or chicken pox. As a result, acetaminophen has attained a reputation for safety.     

In most cases, for healthy adults, both acetaminophen and aspirin are safe choices as long as they are taken as directed for minor problems such as a headache or fever. Adults with ulcers or illnesses that could cause internal bleeding are likely to be steered away from aspirin. And those who consume more than three alcoholic drinks a day are safer avoiding acetaminophen.

Acetaminophen can cause severe liver damage, including liver failure and death, if too much is taken or even if a moderate dose is combined with moderate amounts of alcohol.    

TAKE THE RIGHT DOSE: The maximum dose for acetaminophen is four grams a day, but there is not much margin for error. Eight grams a day, experts warn, could be fatal. If you have a glass or two of wine every night with dinner, have kidney disease, liver problems or hepatitis, you may be able to safely tolerate only two or three grams a day.    

A major reason for overdose is what’s known as a “staggered overdose” — repeatedly taking just a little extra. One study found that patients taking staggered overdoses had a greater risk of dying and were more likely to have liver or brain problems. Most subjects listed pain as the primary reason they had repeatedly taken the extra dose.    

WATCH OUT FOR HIDDEN DOSES: One problem is that acetaminophen is an active ingredient in several hundred over-the-counter and prescription medications, including those recommended for pain, fever, colds and flu, allergy and insomnia.  These medications are best known by their brand names such as Vicodin or Percocet, and even if you know these drugs contain acetaminophen, it’s easy to forget this fact when you’re searching for pain relief.    

A 2009 FDA regulation requires that the word “acetaminophen” be placed on the front of the package and on the “Drug Facts” label of all products containing acetaminophen. Prescription products, however, do not have a “Drug Facts” label, and pharmacists often use the acronym APAP or some shortened version of the term.    

In January, 2011, the FDA asked drug makers to limit the amount of acetaminophen in combination products to 325 milligrams per tablet or capsule. In the past, some of these products — particularly opioids containing codeine, such as oxycodone and hydrocodone — contained as much as 750 milligrams. The dose restriction does not apply to over-the-counter pain medications.

The new regulations will be phased in over three years. In the meantime, the FDA says, patients should talk to their doctors and be careful not to exceed the four-gram maximum per day of acetaminophen.

ELIMINATE DOSING ERRORS: Even formulations clearly labeled acetaminophen come in a variety of forms — drops, syrups, capsules and pills — making it more difficult to determine proper dosing.    

In May of 2011, an FDA advisory panel recommended that all pediatric acetaminophen products be produced in one strength only — 160 milligrams per 5 milliliters. The panel also recommended dosing instructions based on weight rather than age.    

As these new formulations come to market, there is an interim period when older product may still be on the shelves, creating more possibilities for dosing errors.

Acetaminophen is one of the most widely used medications in the United States. And, when used as directed, it is as safe as Julie and other Americans believe. The FDA, however, now requires a boxed warning on all prescription acetaminophen products, highlighting the potential for severe liver injury.

The greatest risks come from: 1. taking more than four grams in a 24-hour period; 2. taking more than one product containing acteaminiphen at the same time, and 3. drinking alcohol while taking the drug.

Staying safe means following one simple rule: take as directed.



Rupp is a certified information and referral specialist on aging for NODA Area Agency on Aging. Contact her at 237-2236.