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 that has been passed along from generation to generation.
In most cases, for healthy adults, both acetaminophen and aspirin are safe choices as long as they are taken occasionally and 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. In fact, acetaminophen overdose is a major reason for liver failure in the United States.
TAKE THE RIGHT DOSE: Many Americans just pop a few pills when they’re suffering pain or fever. The greater the pain, the larger the dose. That’s never a wise move.
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 should talk to your doctor. You may be able to safely tolerate only two or three grams of acetaminophen a day.
The listed maximum dose for Extra Strength Tylenol was once two 500 milligram tablets every six hours–pushing things to the limit. To decrease the risk of overdose, Johnson and Johnson recently reduced that from eight to six tablets daily. Starting in 2012, the maximum dose of regular strength Tylenol was also decreased.
A major reason for overdose is what’s known as a “staggered overdose”–repeatedly taking just a little extra. One study published in the British Journal of Clinical Pharmacology [November 22, 2011] found that patients taking staggered overdoses had a greater risk of dying and were more likely to have liver or brain problems compared to other patients. Most subjects listed pain as the primary reason they had repeatedly taken the extra dose.
It’s also important to consider how much you are using of the drug over the long-term. Over-the-counter remedies are designed for occasional rather than habitual use. Studies have found an increased risk of kidney impairment and even kidney cancer in persons taking acetaminophen fairly regularly over a 10-year period or longer.
WATCH OUT FOR HIDDEN DOSES: One problem is that acetaminophen is not just another name for Tylenol but 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. Use of combination acetaminophen products accounts for about half of all accidental overdoses that result in liver failure.
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 or cold, sinus or cough remedies. Some of these contain 500 to 650 milligrams.
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.
Whether you’re treating yourself or your child, it’s important to be extra careful any time you take more than one medication. Don’t be afraid to ask the pharmacist: “Does this contain acetaminophen?”
ELIMINATE DOSING ERRORS: Even formulations clearly labeled acetaminophen come in a variety of forms–drops, syrups, capsules and pills–and concentrations, making it more difficult to determine proper dosing. Concentrated drops for infants, for example, cannot be given in larger doses for older children without the risk of giving a fatal overdose.
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 (as opposed to 80 mg/0.8 mL). 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. This is the FDA’s strongest warning.
The greatest risks come from:
• taking more than four grams in a 24-hour period;
• taking more than one product containing acetaminophen at the same time, and
• drinking alcohol while taking the drug.
Staying safe means following one simple rule: take as directed.
REFERENCES:
William F. Balistreri, M.D., “Is acetaminophen harmful in children?”Medscape Gastroenterology, January 20, 2011.
Laurie Barclay, M.D., “Acetaminophen: repeated use of slightly too much can be fatal,” Medscape Medical News, November 22, 2011.
Food and Drug Administration, “New steps aimed at cutting risks from acetaminophen,” January, 2011.
Food and Drug Administration Consumer Updates, “Reducing fever in children: safe use of acetaminophen.”
Food and Drug Administration Consumer Updates, “New steps aimed at cutting risks from acetaminophen.”
Ellen Greenlaw, “OTC pain relief: understanding acetaminophen,” WebMD Feature, reviewed by Michael W. Smith, M.D.
Miranda Hitti, “Acetaminophen safety: FAQ,” WebMD Feature.
Robert Lowes, “FDA limits acetaminophen in prescription analgesics,” Medscape Medical News, January 13, 2011.
Marty C. Malheiro, et al, “Recent reformulation of infant acetaminophen products: potential for therapeutic errors,” AccessMedicine from McGraw Hill, May 11, 2012.
Jessica Sotvel, “Alternating acetaminophen and ibuprofen in children: unsafe?” Medscape Pharmacists, March 21, 2011.
“The toxic risks of acetaminophen every consumer should know,” SixWise.com.
“Tylenol dosages lowered to stem overdoses,” Reuters Health, July 29, 2011.
Charles P. Vega, M.D., “Acetaminophen and asthma: a bad marriage,” Medscape Family Medicine, May 2, 2012.
Jennifer Warner, “Infant acetaminophen dosage change m
09/06/2012
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