7/1/09 An FDA advisory panel yesterday voted to recommend lowering the maximum daily dosage of acetaminophen – the active ingredient in Tylenol, Excedrin and other popular painkillers – in over-the-counter (OTC) products to reduce the risk of unintentional overdose. Too much acetaminophen is considered a leading cause of liver failure. The vote was held after the committee heard presentations from the public, including one from Pam Snow, an Arthritis Foundation representative who has osteoarthritis. She spoke of the need to increase consumer safety without restricting access to effective pain relief for people with arthritis [her remarks].
Acetaminophen is an effective solution for many people with arthritis pain and is safe, say medical experts, if used properly. It’s widely used by people with arthritis, because it does not have the gastrointesintal (GI) side effects or potential heart health risks associated with nonsteroidal anti-inflammatory drugs, such as ibuprofen (Advil, Motrin) and naproxen (Aleve).
If you currently take acetaminophen for arthritis pain, “Don’t panic,” says Donald R. Miller, professor and chair of the Pharmacy Practice Department at the College of Pharmacy at North Dakota State University and a member of the Arthritis Today medical advisory board. “All they’re trying to do is prevent people from overdosing. Anyone who is currently taking acetaminophen for arthritis shouldn’t have to change anything.”
The panel voted to strengthen and clarify labeling and to limit the maximum single dose of nonprescription acetaminophen to 650 milligrams (mg) from 1,000 mg. Now most OTC acetaminophen products come in 500-mg pills, with directions to take two pills per dose. The 1,000-mg single-dose option would be available by prescription only. Panel members also called for lowering the maximum daily dosage from 4,000 mg (or eight pills, for example, of Extra Strength Tylenol) but did not suggest a new, reduced maximum daily dosage.
Further, the panel called for banning the prescription drugs Vicodin, Percocet and similar pain medications that combine acetaminophen with narcotic pain relievers, such as hydrocodone and oxycodone. Experts have found that consumers who take those drugs are often unaware they contain acetaminophen. As a result, some unknowingly exceed the recommended maximum daily dosage of acetaminophen, risking liver damage.
Acetaminophen overdose resulted in an estimated 56,000 emergency room visits and 458 deaths over an eight-year period, according to a 2006 review of available data. Because the onset of liver damage is difficult to recognize – a key symptom is a flu-like achiness – it is hard to diagnose and treat in its early stages. The FDA panel is recommending changes in the use of acetaminophen because consumers aren’t highly aware of this possibly dangerous connection.
“I think the arthritis community is certainly going to embrace and support any decision that makes the drug safer for them to use,” says rheumatologist John H. Klippel, MD, president and CEO of the Arthritis Foundation. “The other thing to recognize is that of all the pain medication we know of, acetaminophen is not only one of the most widely used, it is clearly one of the safest when used as prescribed.”
Here are some guidelines for taking acetaminophen safely:
- Take the minimum amount of medication necessary. If your recommended dosage doesn’t relieve your pain, ask your doctor for suggestions. Increasing your dosage even a little beyond the current 4,000 mg maximum daily dosage may cause liver damage.
- Be sure you understand dosing directions. Confirm with your doctor or pharmacist how much acetaminophen you can take at one time, how long you should wait between doses and the maximum dosage you can take in one day.
- Check all labels and prescription inserts. Proceed with caution when taking more than one medication that lists acetaminophen as an active ingredient. Spotting acetaminophen can be tricky: In prescription medications, acetaminophen is often identified as APAP when combined, for example, with codeine, hydrocodone or oxycodone.
- Avoid excessive alcohol. People with pre-existing liver disease or those who consume more than three alcoholic drinks a day are at greater risk for liver toxicity when taking acetaminophen. “If you are a regular drinker or you have any kind of previous history of liver problems, that’s when you want to be careful,” cautions Miller.
- Check with your doctor before you stop taking a medication that has been working for you. “I am worried that many of our patients with osteoarthritis are well managed with acetaminophen or acetaminophen and narcotics, especially when they can’t take NSAIDs because of GI complications, and now they’ll stop taking the medication,” says rheumatologist Chad Deal, MD, of the Cleveland Clinic. “When taken properly, these drugs are effective and safe.”
The FDA is not obligated but is expected to follow the panel’s suggestions, although a final decision is most likely several months away.
to limit to once a day in evening, but sometimes just need it twice a day. But am aware of side effects of possible liver damage. Good thing I am getting liver function studies every 3-4 months for post
breast cancer to try to decrease possibility of reoccurrence of breast CA from 27% to maybe 6% within next few years. Of course, that drug causes bone and joint pain in, and
of itself, so that exacerbates the arthritis.
So give me back my Darvocet and better quality of life.
This will only make the people drink more and smoke pot to kill the pain.
If you want DUI's on your record, and people sueing you because it is your fault (remember lawyers can find anything)then make everyone think the sky is falling!!
Un=Frigging believeable
I been in pain for a year now and dr has yet to prescribe anything that works. Seems fear of addiction and getting sued are of more importance than people like myself who battle pain daily and have no relief!
I might also suggest because of the aging of the population, the directions should be written larger.
Second, the FDA is considering removal of COMBINATION products with acetaminophen added to oxycodone, hydrocodone, etc. The narcotic medications themselves would still be available. Overall, the changes should result in improved safety without affecting the ability of people to get the medication they need.
It's incredible but I don't have pain, I'm not constipated. Really I'm OK.
If you want prove it! It's not dangerous.
Dr.Robin August
Further, if doctors and pharmacies would take time to educate the consumer, perhaps medicines would be taken more safely.
I agree with those asking for better EDUCATION of the consumer! This is what is needed!
Vioxx has already been taken away from us, rather than give us the choice of use to risk. Now Vicodin? How about not showing the constant abuse of these meds ('Dr.' House eating them like candy, with no side effects) on TV? Unfortunately, TV is always 'educating', for good or bad.
THE NEW GUIDE LINES FOR TYLENOL NEED TO BE EXTRA ATTENTION GETTING ...AS WELL AS ALL LIVER DAMAGING MEDS......IN LARGE PRINT
IN THE EARLY 70S I HAD A DR. TELL ME I COULD TAKE AS MANY AS 17-20 TYLENOL(((FOR EXCESSIVE LEG PAIN)))) MY YOUNG DAUGHTER WROTE A REPORT IN H. SCHOOL...CAME HOME WAVING THE PAPER IN FRONT OF MY NOSE TELLING ME I WAS KILLING MYSELF SLOWLY...I READ HER REPORT..AND LOWERED THE HIGH AMT OF TYLENOL IMMEDIATELY....I'M NOW 75. WE HAVE TO RESEARCH FOR OURSELVES ALSO.
"Take the minimum amount of medication necessary. If your recommended dosage doesn’t relieve your pain, ask your doctor for suggestions. Increasing your dosage even a little beyond the current 1,000 mg maximum daily dosage may cause liver damage."
"Panel members also called for lowering the maximum daily dosage from 4,000 mg (or eight pills, for example, of Extra Strength Tylenol) but did not suggest a new, reduced maximum daily dosage."
Do you know of any harmful sideeffects from this drug?
the Dr, gave me a nerve test, and said i have Arthritis and did some x rays,ther are bone sprus all over my hands.I dont really think Tylnol,is going to take care all of this pain!!!!
Again, why not EDUCATE instead of going too far to the extreme by taking some helpful products off the market?
PLEASE bear this in mind when considering changes to protect the public. Education, VERY VISIBILE AND FREQUENT, is key to implement. Please do not make changes that will put me and others in uncontrollable pain.
My doctor changed me to Propoxy-N/APAP 100-650 TA (1 tablet every 4 hours as needed for pain) saying that it contained a narcotic, but less of the acetaminophen. Now I am reading in the news that the FDA may pull this medicine.
I am concerned because this works really well for me, but I don't want to take it if it is dangerous to me. Should I continue the medication I have on hand or should I discontinue immediately?
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