By David Dunaief, M.D.

Many of us keep a supply of over-the-counter medications for pain relief, fever and inflammation in our medicine cabinets. Typical “staples” are acetaminophen and a variety of NSDAIDs (non-steroidal anti-inflammatory drugs), like aspirin, ibuprofen, naproxen sodium and diclofenac sodium. These tend to be our “go to” medications when something ails us.

Americans consume more than 30 billion doses of NSAIDs a year, including both over-the-counter (OTC) and prescription-strength (1). As for acetaminophen, also known by the brand name Tylenol, one quarter of Americans take it weekly.

Unfortunately, many think these drugs are low risk, because they’re so accessible and commonplace. Many of my patients don’t even include them in a list of medications they take. I have to specifically ask about them. According to a poll of regular OTC NSAID users, 60 percent were not aware that they can have dangerous side effects (2).

What are risks of taking NSAIDs?

Unfortunately, NSAIDs, according to the Centers for Disease Control and Prevention, are responsible for 7,600 deaths annually and 10 times that number in hospitalizations (3). 

NSAIDs increase the risk of heart attacks, gastrointestinal bleeding, stroke, exacerbation of diverticular disease, chronic arrhythmias (abnormal heartbeats) and erectile dysfunction. In some instances, the cardiovascular effects can be fatal.

These risks prompted the FDA to strengthen the warning labels on non-aspirin NSAID labels in 2015, advising that those taking NSAIDs should immediately seek medical attention if they experienced chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech (4).

As recently as late 2020, the FDA added a warning label to non-aspirin NSAIDs about the potential for fetal kidney damage and pregnancy complications beginning around week 20 of a pregnancy (4).

In a case control study using the UK Primary Care Database, chronic users of NSAIDs between ages 40 and 89 had a significantly increased risk of a serious arrhythmia (abnormal heartbeat) called atrial fibrillation (5).

Interestingly, researchers defined “chronic users” as patients who took NSAIDs for more than 30 days. These users had a 57 percent increased risk of atrial fibrillation. A Danish study reinforces these results after the first month of use (6). This is not very long to have such a substantial risk. For patients who used NSAIDs longer than one year, the risk increased to 80 percent. 

NSAIDs also increase the risk of mortality in chronic users. Older patients who have heart disease or hypertension (high blood pressure) and are chronic NSAIDs users are at increased risk of death, according to an observational study (7). Compared to those who never or infrequently used them over about 2.5 years, chronic users had a greater than twofold increase in death due to cardiovascular causes. 

High blood pressure was not a factor in this study, since the chronic users actually had lower blood pressure; however, I have seen that NSAID use can increase blood pressure with some of my patients.

What are the risks of acetaminophen?

The FDA announced in 2011 that acetaminophen should not exceed 325 mg every four to six hours when used as a prescription combination pain reliever (4). The goal is to reduce and avoid severe injury to the liver, which can cause liver failure.

There is an intriguing paradox with acetaminophen: Hospitals typically dispense regular-strength 325-mg doses of the drug, whereas OTC doses frequently are found in “Extra Strength” 500-mg tablets, and often the suggested dose is two tablets, or 1 gram. At the FDA’s request, Tylenol lowered its recommended daily dosage for extra strength Tylenol to no more than 3 grams a day.

One study that showed acute liver failure was due primarily to unintentional overdoses of acetaminophen (8). Accidental overdosing is more likely to occur when taking acetaminophen at the same time as a combination sinus, cough or cold remedy that also contains acetaminophen. OTC and prescription cold medications can contain acetaminophen.

Of course, if you already suffer from liver damage or disease, consult your physician before taking any medications.

In order to protect yourself from potentially adverse events, you must be your own best advocate; read labels, and remember to tell your physician if you are taking any OTC medications.

If you are a chronic user of NSAIDs or acetaminophen because of underlying inflammation, you may find an anti-inflammatory diet is an effective alternative.

References:

(1) Medscape.com, 2021 Oct 21 (emedicine.medscape.com/article/816117-overview). (2) J Rheumatol. 2005;32;2218-2224. (3) Annals of Internal Medicine, 1997;127:429-438. (4) fda.gov (5) Arch Intern Med. 2010;170(16):1450-1455. (6) BMJ 2011;343:d3450. (7) Am J Med. 2011 Jul;124(7):614-620. (8) Am J Gastroenterol. 2007;102:2459-2463.

Dr. David Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, visit www.medicalcompassmd.com or consult your personal physician.