Inflammatory arthritis [IA], an autoimmune condition, includes rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
Paracetamol is recommended for the treatment of persistent pain in patients with IA.
Data from 12 short-term randomized controlled trials (RCTs) at high risk of bias provided weak evidence for a benefit of paracetamol over placebo and an additive benefit of paracetamol in combination with NSAIDs ….
There was consensus among the experts that paracetamol is generally a safe and effective analgesic in IA, both alone and in combination with other pain pharmacotherapies. It was recognized that there is variation between countries in the maximum recommended dose and that clinicians should follow local dosing guidelines. No evidence exists regarding the preferred formulation or dosing interval.
Whittle, S., et al. (2012) Multinational evidence-based recommendations for pain management by pharmacotherapy in inflammatory arthritis: integrating systematic literature research and expert opinion of a broad panel of rheumatologists in the 3e Initiative. Rheumatology. Retrieved from http://m.rheumatology.oxfordjournals.org/content/early/2012/03/23/rheumatology.kes032.full.
Note that only paracetamol/acetaminophen, NSAIDs and placebos were studied. If NSAIDs do not provide enough pain relief? There’s no answer to that because the question wasn’t asked.
The panel’s findings:
- Paracetamol (acetaminophen) is recommended for the treatment of persistent pain.
- Weak opioids are recommended for short-term treatment of pain only when other treatments have failed or are contraindicated but caution should be advised for long-term use and strong opioids should only be used in extreme cases under close supervision.
- A drug with a different mode of action should be added if acetaminophen or nonsteroidal anti-inflammatory drug (NSAID) monotherapy is inadequate, but 2 or more NSAIDs should not be combined.
(2012) 11 recommendations reported for arthritis pain management. Drug Topics. Retrieved from http://drugtopics.modernmedicine.com/drug-topics/news/clinical/pharmacy/11-recommendations-reported-arthritis-pain-management?page=full.
Yes, Tylenol, the liver-demolishing pain reliever, is considered the best pain relief and management for inflammatory arthritis pain in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. The pain of inflammatory arthritis is not temporary and lasts a lifetime, so a lifetime of Tylenol is the best “recommendation.”
Even though Tylenol most likely does not cause serious liver damage in recommended doses, it can cause elevations of liver enzymes in the blood suggesting injury to the liver. In a study of 145 healthy subjects who were randomized to receive placebo or 4 grams of Tylenol daily for two weeks, subjects in the placebo group experienced no elevations of ALT, a liver enzyme, but 33%-44% of the subjects in the Tylenol group had ALT elevations greater than three times the upper limits of normal. The highest ALT elevation was greater than 500 which is approximately 10 times the upper limit of normal. All enzyme elevations returned to normal after stopping Tylenol. Thus, recommended doses of Tylenol given to healthy subjects for two weeks can cause mild to moderate reversible liver injury. [emphasis added]
Lee, D., & Marks, J. Tylenol Liver Damage. MedicineNet.com. Retrieved from http://www.medicinenet.com/tylenol_liver_damage/page2.htm.
Tylenol is not without its serious complications. It is the leading cause of acute liver failure in the United States, and the drug in some cases led to fatalities. The active ingredient in Tylenol, acetaminophen, accounts for more than 100,000 calls to poison centers, roughly 60,000 emergency-room visits and hundreds of deaths each year in the United States. In England, it is the leading cause of liver failure requiring transplants. In 2009, the FDA issued guidelines for adding overdose guidelines to packages and in 2011, the agency confirmed the link between the drug and liver damage.
In October 2013, Johnson & Johnson will add a warning to the caps of bottles of Extra Strength Tylenol warning consumers that the drug contains acetaminophen and may cause liver failure. Severe liver damage from the drug led people to file lawsuits against Johnson & Johnson and/or McNeil. On April 1, 2013, a judge consolidated several federal lawsuits in multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania.
Tylenol. Drug Watch.
Acetaminophen is often used in pain medications with opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine). These are called combination drugs, and the Food and Drug Administration is asking doctors to stop prescribing those that have more than 325 mg of acetaminophen per dose.
The FDA says no data show that taking more than that amount provides enough benefit to outweigh the risk of liver damage.
FDA: Acetaminophen doses over 325 mg might lead to liver damage. CNN.
Q. Are there risks from taking too much acetaminophen?
A: Yes, acetaminophen can cause serious liver damage if you take too much. It is very important to follow your doctor’s directions and the directions on the medicine label.
You may not notice the signs and symptoms of liver damage right away because they take time to appear. Or, you may mistake early symptoms of liver damage (for example, loss of appetite, nausea, and vomiting) for something else, like the flu. Liver damage can develop into liver failure or death over several days.
Acetaminophen is generally safe when taken as directed. To lower your risk of liver damage make sure you do the following:
- Follow dosing directions and never take more than directed; even a small amount more than directed can cause liver damage.
- Don’t take acetaminophen for more days than directed. [Chronic pain is every day so recommending acetaminophen for inflammatory arthritis is recommending that it be taken for years, even decades.]
- Don’t take more than one medicine that contains acetaminophen at a time. For example, your risk of liver damage goes up if you take a medicine that contains acetaminophen to treat a headache, and while that medicine is still working in your body, you take another medicine that contains acetaminophen to treat a cold.
FDA: Acetaminophen and Liver Injury: Q & A for Consumers
But is Tylenol really the answer for inflammatory arthritis pain?
The clinical trials identified compared paracetamol to placebo, NSAID, or weak opioids; 2 compared paracetamol + NSAID to placebo + NSAID. Several studies included multiple arms using different comparators and were therefore included in the analysis for more than 1 comparator group. Eight articles, with a total of 9 separate trials, included pain as an outcome measure and were included in the efficacy analysis (7,8,9,10,12,13,14,15). Three articles included safety data but did not include pain as an outcome measure and were therefore included only in the safety analysis (5,6,11). Two trials were parallel-group design (10,11) and the remaining were crossover. The included studies were older (1959–1993), had small sample sizes (range 12–143), short trial duration (range 6 –13 wks), and often used atypical doses of paracetamol (range 650 mg/day–7.5 g/day).
Based on 8 trials with high risk of bias we found weak evidence for the following in patients with RA: an increased benefit of paracetamol over placebo, an uncertain benefit of NSAID over paracetamol, no difference between paracetamol and weak opioids, and an additive benefit of paracetamol in combination with NSAID. There was no evidence in patients with other forms of inflammatory arthritis. For the efficacy of paracetamol versus NSAID in patients with RA, the SLR we identified in our search drew a similar conclusion: the trials were of poor quality and it was uncertain whether NSAID were superior to paracetamol.
The design of the studies was not reflective of current practice, leading to difficulties in extrapolating the results to treatment recommendations. The doses of medications used were atypical, the study duration was too short for the treatment of a chronic pain condition, and the comparators included medications not commonly used.
Extrapolating these results to treatment recommendations is difficult. When limited disease-specific data are available to guide the therapeutic choice, other disease models may provide insight. When pain medications are tested in chronic pain, osteoarthritis is often the model used. In a recently updated Cochrane Review on the efficacy and safety of paracetamol in osteoarthritis that included 15 RCT with a total of 5986 patients, there was evidence to support the efficacy of paracetamol in comparison to placebo, but with a low overall effect size (SMD –0.13, 95% CI –0.22 to –0.04) (18). When compared with NSAID, paracetamol was found to be less effective, but had a decreased risk of any GI event when compared with traditional NSAID (number needed to harm 12, 95% CI 6 to 66) (18). In summary, the results of this systematic review showed that there is limited disease-specific evidence to support the role of paracetamol in the treatment of pain in patients with inflammatory arthritis. The available evidence, all with high risk of bias, suggests that there is a potential benefit of paracetamol, alone or when combined with NSAID in patients with RA. Given the relative paucity of information, recommendations should incorporate expert opinion and may rely on extrapolation from evidence in other chronic pain conditions. [emphasis added]
Hazlewood, G., van der Heijde, D., & Bombardier, C. (2012) Paracetamol for the Management of Pain in Inflammatory Arthritis: A Systematic Literature Review. Journal of Rheumatology. Retrieved from http://www.jrheum.org/content/supplements/90/11.full.pdf?keytype=ref&siteid=jrheum&ijkey=ImD9.ayCp0G5Y [PDF].
So the recommendation is a guess based on an arthritis not like rheumatoid arthritis, spondyloarthritis or ankylosing spondylitis that leaves out many variables and conditions, such as long-term use for chronic pain, and is drawn from studies with bias and reporting problems. But even with “difficulties in extrapolating the results to treatment recommendations,” it is still in the recommendations, and implies to me that rheumatologists and pain management doctors are being advised that acetaminophen/paracetamol is an effective pain reliever for chronic inflammatory arthritis pain and is safe for long-term use, safer and far more “desirable” than opiates, even “weak” ones.
If Tylenol handled my inflammatory arthritis pain, I never would’ve gotten a diagnosis because I never would’ve mentioned to my motherfucking doctor how much fucking pain I was [and am] in.
So if my severe pain isn’t alleviated by Tylenol or NSAIDs, I’m shit out of luck and have the privilege of living with severe pain every day until I fucking die? That’s medical care? That’s pain management? Am I getting something wrong here? I know I’m kind of pain-addled right now but I am seeing what I’m seeing, am I not?