Almost everyone takes a pain reliever now and again. It might be for a headache, a muscle strain or arthritis. Occasional use is considered reasonably safe. But regular use of most OTC analgesics poses significant risks. We suspect that the average person 1) rarely bothers to read labels and 2) cares most about pain relief and 3) doesn’t worry much about adverse reactions. That could be a big mistake!
A Reader Worries About Pain Reliever Safety:
Q. A lot of people take over-the-counter pain medicines, but I suspect most don’t know about side effects. Tylenol can cause serious liver damage, even liver failure, but the public is not adequately warned.
All of the NSAIDS [nonsteroidal anti-inflammatory drugs], including OTC drugs like ibuprofen and naproxen, have ominous warnings about serious bleeding in the digestive tract as well as the risk of stroke or heart attack. The public trusts these OTC medicines and some people overuse them.
In my opinion, they should be prescription drugs with limits on the dosage. What do you think?
A. You have identified a serious problem with the way people think about medications. Most consumers perceive prescription drugs as strong and potentially hazardous. Virtually every prescription drug commercial describes frightening adverse drug reactions.
Crying Wolf Desensitizes People:
There was a time when drug companies argued with the FDA about the need to include negative information in promotional material. We suspect that drug company advertising executives no longer fear listing a bunch of scary side effects during TV commercials.
Telling people that a psoriasis medication or a drug for eczema can increase the risk for heart attacks, strokes, blood clots, serious infections or cancer does not deter doctors from prescribing such medicines and does not scare patients away from taking them.
There is an added “benefit” for the pharmaceutical industry. Once a drug company reveals a nasty side effect, it is no longer vulnerable to a lawsuit if someone is harmed or killed.
Many people assume that OTC medications have to be safe. Why else would the FDA see fit to approve these products without any medical supervision? Many, including acetaminophen (Tylenol), ibuprofen (Motrin) and naproxen (Naprosyn) were once only available by prescription.
What’s In Your Pain Reliever?
As far as I can tell, the FDA has done very little research to discover how vigilant consumers are when it comes to reading labels. A small study published over a decade ago in the American Journal of Preventive Medicine (June, 2011) revealed some startling data. These researchers asked six focus groups about their knowledge of the over-the-counter pain reliever acetaminophen (Tylenol).
In their introduction, the authors noted that:
“In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage.”
In this survey, the investigators asked respondents:
“Before you take over-the-counter pain medicines, how often do you read the instructions for use? with response options of always, often, sometimes, rarely, or never…”
Fewer than 50% of the people questioned bothered to read instructions.
Many had no idea what drug they were taking:
“Despite regulations in place since 1999, which require active ingredient information to be listed first in Drug Facts on all OTC products, the present study found that few participants knew acetaminophen is the active ingredient in Tylenol. Poor recognition of which products, both OTC and prescription, contain acetaminophen is not uncommon and has been found in other studies among patients seeking medical attention for a complaint of pain. Americans commonly identify OTC pain relievers by brand name rather than generic (or active ingredient) name.”
Less than a third of the volunteers knew that acetaminophen is the active ingredient in Tylenol.
Another study confirmed similar dismal results with regard to NSAIDs (American Journal of Medical Sciences, Nov. 2016). The researchers reported that in 2012 “…more than 30 billion doses of OTC NSAIDs are consumed annually in the United States.” Today, I am willing to bet it’s a lot more.
Most People Did Not Know What Was in Their Pain Reliever:
The authors found:
“Awareness of NSAIDs was generally poor. Ibuprofen, correctly identified as an NSAID by approximately half of respondents, was the most well-recognized NSAID. Less than half of the respondents could recognize any other NSAID by name (brand or generic), and the same percentage of people who could identify naproxen as an NSAID were unsure if any products were NSAIDs. Tylenol was incorrectly identified as an NSAID by one-third of respondents, and only a minority of respondents identified Alka-Seltzer and aspirin powders as NSAIDs.”
Other misperceptions about the use of a pain reliever:
“Many respondents also reported using more than the recommended dose of an OTC medicine (28% [3% unsure]), primarily by taking more than the recommended number of pills at a time (71%) or the next dose sooner than directed (47%).”
“ In addition, up to 35% of respondents in the current survey reported using more than 1 NSAID concomitantly…”
“Perceptions about the safety and efficacy of prescription and OTC NSAIDs were also evaluated in the Alliance survey. Prescription NSAIDs were thought to be more effective by 42% of respondents and safer by 19%. OTC NSAIDs were thought to be more effective by 12% of respondents and safer by 31%.”
Your OTC Pain Reliever Must Be Safe…Right?
Most people assume that acetaminophen (APAP) must be super safe. Many have heard about or experienced digestive tract upset from NSAIDs like aspirin, ibuprofen or naproxen. But APAP is not supposed to do that. Consequently, the assumption may be made that there is little, if anything, to worry about about from drugs containing acetaminophen.
As the reader who asked the original question pointed out, liver toxicity is a real concern, especially if people swallow too much APAP. It’s easier than you might think. That’s because acetaminophen is often found in a variety of OTC products from cold and cough remedies to sleep aids and allergy meds.
You can learn how easy it is to overdose on acetaminophen at this link:
If Acetaminophen is Killing People Why Should You Trust Tylenol?
Even if you never exceed the recommended dose of APAP you can still experience adverse reactions. Some people report that blood pressure goes up on acetaminophen. Here is a link to an article on this controversial topic.
Can Tylenol – Acetaminophen Raise Blood Pressure?
There are also reports that acetaminophen is linked to asthma and serious skin reactions. Read about such complications at this link.
One last warning: acetaminophen in combination with alcohol can pose problems. The maker of Tylenol has spanked us for warning consumers about this interaction. You can read about this controversy and other APAP side effects at this link.
What If You Take an NSAID Pain Reliever?
If people bothered to read the warnings on NSAID pain reliever packaging, they would likely be surprised to learn that ibuprofen or naproxen are inappropriate for many people. Both labels state that consumers should ask a doctor if warnings about bleeding ulcers would apply.
The labels also suggest checking with a healthcare professional before using if the patient takes other drugs or has high blood pressure, heart disease, cirrhosis of the liver, kidney disease, asthma or has had a stroke. Since most people do take other drugs, the label implies that almost everyone should consult a physician before swallowing an OTC pain reliever containing an NSAID such as ibuprofen or naproxen.
We suspect that most people do not worry about side effects from NSAIDs.
Here is what the study on these pain relievers discovered (American Journal of the Medical Sciences, Oct. 11, 2016):
“NSAIDs׳ AEs [adverse events] are often underestimated and are not well understood. As was reported in past surveys, greater than two-thirds of respondents still believed they were at no or slight risk for NSAID AEs, and fewer were very concerned about AEs than in past surveys. Only 40% of respondents in the current survey were aware that NSAIDs could cause digestive, cardiac and renal AEs. Only 10% of respondents were currently aware of the cardiac risk with NSAIDs.”
Should you wish to learn more about the heart complications and other side effects associated with ibuprofen, here is a link you should read. And if you would like to learn more about the negative consequences of naproxen, here is a link.
Final Words:
It has been our experience that a lot of people much prefer to shoot the messenger rather than come to grips with the risks of an OTC pain reliever. Remember, I started this article by stating that occasional use is relatively safe. But people dealing with chronic pain, such as those with arthritis, have to use something every day or even multiple times a day.
We do offer some nondrug options that we think are safer in our eGuide to Alternatives for Arthritis. This online resource can be found under Health eGuide tab.
Most people are opposed to the idea of restricting access to OTC pain relievers, as the reader at the beginning of this post suggests. Even though such drugs can cause very serious complications, most people do not care.
If someone experiences a heart attack, stroke, liver damage or bleeding ulcer, they may not attribute it to their use of an OTC pain reliever. And if someone has a heart attack and dies while taking ibuprofen or naproxen, chances are that good that the death certificate will not blame the NSAID.
We think the pharmaceutical industry has let us all down. Even after decades of research, drug companies have not offered us a decent pain reliever that is really safe and effective. Until that day arrives, people need to be extra vigilant.
Please share your own experience with acetaminophen, ibuprofen or naproxen in the comment section below. We would like to hear all sides of this discussion. If you love APAP or NSAIDs, please let us know. If you have experienced side effects, share that information. And please be honest: do you read the label of your OTC pain reliever?
