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FDA Panel: There Are Ways to Make Acetaminophen a Safer Painkiller

A popular drug for arthritis pain relief is still safe, if you use it wisely.

By Mary Jo DiLonardo

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.

John Rooney
10 May 2011, 11:46
I take 1 Tylenol 650 mg and 1 Hydrocodone 500 mg for sciatic pain once a day in the A.M. My question is how far apart do I have to space them so as not to worry about liver damage ? Thank You.....
Leona
17 Feb 2011, 20:44
I have been taking 2 extra strength tylenol for at least 10 years for pain from pinched nerves in my back. I have just recently decided to stop taking tylenol to cut down on the danger of liver damage. Are there any side effects for stopping taking tylenol after such a long time using it?
Elizabeth Gilbert, RN
13 Jan 2011, 10:25
Now that Darvocet has been taken off the market for those of us who suffer from arthritis- I have resorted to 3 extra strength-fast acting Tylenol-at one time-try
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.
Citizen
11 Jul 2010, 12:10
FDA WAKE UP!!!!!
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
MotherHeart
05 May 2010, 00:40
This is so sad to hear. I have chronic pain of fibromyalgia right now I have lortabs -- don't work at all for me and flexril == haven't noticed much relief. I will probably need to take something stronger to relieve this pain but they're thinking of taking them off the market! I am in constant daily pain! I used to be extremely active person and now I can barely walk most days! Please people rethink this there are many of us in dire pain and we need relief.

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!
terry
30 Mar 2010, 13:22
Banning vicodin, are you kidding...That drug has helped so many in pain including cancer...Its a wonder drug if use correctly..The dr. needs to give our rx very carefully...BUT TO FREAKEN BAN IT...THE DOCTORS MUST BE CRAZY.!! WHY NOT TAKE ALEVE, MOTRIN AND ECT AWAY....ANYTHING USED ABUSIVELY IS BAD FOR YOU...GIVE ME A BREAK!
Janie Jackson
19 Jan 2010, 12:03
I have fibromyalgia, osteoarthritis, spinal stenosis, hip problems and other problems from a fall down a flight of stairs. I take a regimen of medications, the most important being Norco 10/325. It is the only thing that helps without going to something much stronger and more dangerous. I cannot take hydrocodone with ibuprophen (generic) because it causes me to gain 14 pounds of water weight and I have developed bad cellular damage in my legs. If they change my medication, I will be in a lot of trouble!!! I agree with the others--Leave the dosing of our medications alone and do a huge education drive in electronic and print media. Why always take away medications so the people who really need them suffer; when the real problem is either illegal use or stupidity for not following directions. Use the power of the media!!!!
I might also suggest because of the aging of the population, the directions should be written larger.
WILLIAM KILBERRY
15 Dec 2009, 11:57
I TAKE 1OR 2 VICODIN PILLS WHEN I HAVE A LOT OF PAIN IN MY LOWER BACK, AND MY HIP, I HAVE HAD REPLACED, I DONT TAKE PILLS NO MORE THEN 4 HOURS APART, IS THIS OK
mitzi
04 Dec 2009, 06:29
I too take the hydrocodone/apap 10. I have chronic problems that will not go away. I have tried the combo without the tylenol in it and it does NOT work as effectively and the ones with the tylenol. And what the FDA does not understand about it is-people will still just go buy tylenol OTC and take it anyway. I know it covers their butt, however it doesnt solve the problem. More awareness and more frequent checking by the physician would alleviate some of it. Seems its an individual choice whether to kill their liver or not. I take milk thistle weekly to help ai in liver cleansing.
Lettie Butler
31 Jul 2009, 22:48
I'm very concerned about the new dosage for tylenol. I too was taking Meloxican, the minimun dosage because the Tylenol didnt stop my pain of degenerative Osterarthritis in my goin area..I'm in the process of trying to eat healthy lots of fruit and vegetables and using cherry juice for the inflammation and pain.
Dr. Donald Miler
24 Jul 2009, 10:39
Two clarifications. As Barbara mentioned, proposed FDA regulations would only affect the availability and labeling of OTC acetaminophen. You could still use higher doses under your doctor's supervision.
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.
Jennifer Peebles
22 Jul 2009, 04:45
I am concerned to read that they are considering taking Hydrocodone away. If my pain is really bad...it is the only one that works as I have Crohn's Disease and cannot use any aspirin products ever in my life. My kidneys and liver are tested through my blood regularly. I only have times when my pain is really bad. I use the Rapid Release Gels made by Tylenol and only as directed. My mom saw the TV information concerning overusing Tylenol. Thanks for helping us. It is sad to think that people are not paying attention to the Tylenol in other products.
LILIAM
21 Jul 2009, 20:05
I'm from Peru so I speak English more less but I have to tell you something. I'm a patient with rheumatoid arthritis and I was taking a lot of medicine and I was good but my wallet don't. I didn't have too much money for the medicine so I herd to my mother about linseed. I know that it has to be tested but I put in hot water two spoonful of linseed, wait for 1 hour then you can eat or you can liquefy and drink every day in the morning or at night if you can't.
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
21 Jul 2009, 17:41
As one who writes a blog on Fibromyalgia and Chronic Fatigue Syndrome, I am astonished about the lack of thorough thought as to what this mess is doing to people who need to take drugs like Vicodan to survive. These people are very frightened about the talk of Vicodan and Percocette being taken off of the market with no alternatives available that are spoken about. This is CRUEL!! The FDA should get its act together and realize that there are many people who have legitimate needs for pain killers. If you are going to take Vicodan off the market, why aren't you discussing a Vicodan which has little to none acetaminophen in it?

Dr.Robin August
D
21 Jul 2009, 16:33
I agree with alot of you about education. You cannot always trust the doctor or the drug companies to warn you of everything they should. Whether it just slips their mind or if they just don't put it boldly enough.Every time I take a new med or change meds. I type it and all my others into an online drug interation site and you would be surprized how many times you get red flags. I personally would want to know all the side effects of all my meds and whether they should be taken together. But that is me. I am also so happy when I get any relief at all from my RA,Gout,and Fibromyalgia.
Macky
21 Jul 2009, 15:50
Laurie, the article contradicts itself! The 4th paragraph says: maximum daily dosage from 4,000 mg (or eight pills, for example, of Extra Strength Tylenol) and the 1st paragraph of the guidelines says: Increasing your dosage even a little beyond the current 1,000 mg maximum daily dosage may cause liver damage.
Cynthia Wilder
21 Jul 2009, 15:47
I have Fibromialgia,Degenerative disc disease,Osteoarthritis,Arthritis in knees and ankle,nerve damage in my arms, back and neck, buldging disc,and bone spurs in my knees and I was taken off Oxycotin and put on Vicodin in Er and then Hydrocodine/apap 500 mg 4-5 times a day as needed for pain. Am also on muscle relaxer(Baclofen), Lyrica,and Naproxin to name a few.I have bad headaches and take Topomax 1 times a day and have to take 2 Excedrin migraine with everything to get rid of the headaches on occassion. If they do away with my meds or decrease them I will not be able to move and will be in a wheelchair. I am checked by my Dr by getting bloodwork done to watch my levels and make sure there are no problems. When patients are getting their blood work done and the levels are good there should be no problems but if they have a problem seen then and ONLY THEN check into other meds for that patient to see what is to their best interests. This is my opinion. Thank you.
Laurie
21 Jul 2009, 14:05
The first comment by 'Mary' just shows how people do not read information completely. The max DOSE is 1000mg, the max DAILY DOSE is 4000mg, clearly stated in the article.
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.
Barbara
21 Jul 2009, 14:03
The FDA is stating that OVER THE COUNTER use of Tylenol is creating problems. It will allow prescription medication at the higher dose. Also, if your RA physician recommends a higher dose than what the label indicates, question the physician but follow his/her recommendation. Every medication is a selective poison; one must decide if one is better with the poison or without it! FDA is concerned about people who are unconcerned about the medications they are taking!
Lucy Herring
21 Jul 2009, 14:01
IF IT ISN'T BROKE ....DON'T FIX IT.
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.
Mary
21 Jul 2009, 11:55
The current maximum daily dosage is 4,000 mg, not 1,000 mg.

"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."
Sandra Thornton
21 Jul 2009, 11:47
I noticed they just put a stronger warning on Darvocet and I hope this same practice is carried out with oxycodone as it took me 10 years to find a drug that worked through trial and error. If this drug is taken off the market I will be back to square one and once again become nonfunctional with my arthritis, fibromyalgia, degenerative disk disease.
John
21 Jul 2009, 11:37
I have had Fibromyalgia and osteoarthritis and soft tissue disorder for 7 years now.I had to take 8 10/5 loritabs per day to relieve the pain.After a few years it did not help anymore so my doctor put me on 10 to 40 mg of methadone per day.This takes care of my pain better than Loritab ever did.
Do you know of any harmful sideeffects from this drug?
Alice
21 Jul 2009, 11:13
I just went to a hand Dr, the other day i have a lot of pain in my hands and nerve pain
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!!!!
SUJAY BASU
21 Jul 2009, 11:03
I had severe bouts of gout, and though I tried all medicines nothing worked and the side effects of allopathy was too much to bear, finally I started loosing all hopes, then I came accross Aloe Vera Based products from FLP absolutely natural and with the combinations of Aloe Freedom, Arctic Sea, Garlic Thyme and by applying Forever Heat Lotion and MSM gel within a span of six months got all fit, and for the last one year did not receive any bout of Gout attacks. One can contact at flpindia.basu@gmail.com for further informatins
Dianne
21 Jul 2009, 10:43
I take fiorcet for migraine and did not realize that it had acetaminophen because it is tylenol based. and took Excedrin on other days because too much fiorcet can cause what is known as rebound headaches and then found out that it also contained acetaminophen. Thankfully my rheumatologist tests my blood every three months because of all the meds I am on so I am sure if there was anything wrong she would be the first to know. Now I'll have to ask my neurologist what I can take to safely get rid of my migraines.
Martha Ory
21 Jul 2009, 09:47
I am concerned about all these changes concerning tylenol. I found it to be the only drug that has helped my pain, however I have tried to be very careful with it. I just had knee replacement surgery and am taking Vicodin I don't take the recommended dose i take much less but I have found it to be very helpful for pain relief. I hope that all these people who did the research will also research to find something else that is safe for pain relief. I have been unable to tolerate any of the NASAIDS, so tylenol has been my only recourse
Claudia Metting
21 Jul 2009, 09:28
I had been a school nurse for many years and have seen a big problem with OTC(over the counter)drugs once they added multi-ingredients. Many parents would give Tylenol along with products containing more Tylenol(acetaminophen) because they did not READ the ingredients in the "cough" medicine. I believe it is an EDUCATION problem and would also be more helpful to take the acetaminophen out of cold products than penalize those that need them for pain products.I have chronic pain and am monitored for increased liver enzymes.
Again, why not EDUCATE instead of going too far to the extreme by taking some helpful products off the market?
Jenna Austin
21 Jul 2009, 09:16
I am confused why they are redosing Tylenol when it is the only over the counter drug pushed by Rheumatologists and is the only pain reliever safe enough to take during pregnancy. I couldn't have gotten through my pregnancy with my daughter without Tylenol as a woman with RA it is too dangerous to take Aleve, Advil, etc during pregnancy. I am not sure what the FDA is thinking but they certainly aren't thinking about people with RA or OA. Totally irresponsible to forget about the people that are in daily pain.
Carol S. Brotman
03 Jul 2009, 22:03
I am very concerned about a change in the maximum individual dose of Tylenol. For at least four years, I have been taking 7.5mg of Meloxicam followed by two Tylenol Arthritis (650mg ea) two times a day. I cannot take more of the Meloxicam or other NSAIDs due to high heart risk and heart disease in my family. I cannot take Aleve or any ibuprophen due to GI risk and other reasons. So my usual max dose of Tylenol is 2,600/day, but sometimes 3,200. I DO NOT exceed the max recommended of 3,900 of this product. This medication regimen plus analgesic relieving gel, exercise and proper eating and weight management keep me going. I have thus far, had 7 surgeries for my OA which include two total knee replacements. I DO NOT KNOW WHAT I WOULD DO IF THE MAX DOSE PREVENTED MY 650X2 OF TYLENOL ARTH. I am in good health. AND 7 years ago, I was a live liver donor to my husband. Today both of us are in good liver health.

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.
Gertrude Houchens
02 Jul 2009, 09:32
I was taking a lot of Tylenol Max Strength for pain relief from chronic back pain caused by Osterarthritis in my lower back.
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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