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Tip Sheets

OTC pain relief doesn't come without risks - especially for seniors

By Cheryl Clark

These days, it’s rare to open a medical journal, turn on the TV or read a newspaper without seeing one or more articles about the dreaded opioid epidemic, which claimed some 72,000 lives in 2017 alone and sends more than 100,000 seniors to the hospital with overdoses every year.

With government regulators, medical boards, risk managers and health plans now shadowing their practices, physicians are growing increasingly petrified of prescribing narcotics. They’re tapering off their patients’ doses, prescribing less to begin with, or flat out refusing to prescribe controlled substances all, referring those patients out to pain specialists or psychiatrists. 

Overwhelmed, some pain specialists are also setting limits on how far they’ll go with opioid prescriptions, and sometimes getting so backed up with patient demand they’re sending those patients back to their primary care provider. The New York Times reported on this conundrum back in March. Surgeons also are writing fewer opioid prescriptions for their surgery patients.

So it stands to reason that many seniors with arthritic pain, neck and back aches, headaches or who are recovering from an injury may be frustrated that they are now encountering obstacles to getting the relief they’ve come to count on. Many will look for readily available, inexpensive substitutes they can buy without a prescription.

They may very well grab whatever they can find over the counter that advertises “pain relief.”

But while those OTC drugs may be safer than narcotics or opioids, they are not without serious — and arguably under-recognized — risks, especially for seniors whose stomach linings and ability to safely absorb pills and tablets diminish with age.

A recent paper that attempts to educate clinicians about these risks was produced by the Gerontological Society of America. It referenced one study with some scary statistics about a class of analgesics called NSAIDS, or non-steroidal anti-inflammatory drugs, such as aspirin, naproxen (Aleve) or ibuprofen which are sold over the counter, or indomethacin, celecoxib, or higher-strength naproxen (Anaprox), by prescription.

The chief danger is in gastrointestinal complications such as bleeding that disproportionately affect older people. A New England Journal of Medicine paper referenced some 103,0000 hospitalizations annually due to NSAID use, and 16,500 NSAID-related deaths in patients with rheumatoid arthritis or osteoarthritis, or between 5 and 10 percent of patients hospitalized.

The problem is, that paper was published nearly 20 years ago.  Since then, there’s been a much more concerted effort among clinicians to have patients take NSAIDs with food to mitigate any GI impacts. They’re also now encouraged to supplement their pills with a proton pump inhibitor such as Zantac or Prilosec, to reduce production of acid that can erode gastrointestinal tissue and lead to bleeding. 

Those preventive precautions, however may or may not have cancelled out the fact that there are now more OTC pain products available, and that there are more older people now self-treating for chronic pain.  They also may have no effect on the patient who can buy and take however many tablets he or she wants absent any physician direction or oversight. So it’s unclear whether those numbers have changed.

As this AHCJ story from March previously noted, using an integrative approach that includes both complementary and alternative medicine, is one alternative to helping patients manage consistent pain.

Another concern is kidney damage from NSAID overuse, with numerous small studies documenting instances of hospitalization, and sometimes resulting in the need for kidney dialysis.

Still another worry about these inexpensive and easily obtained products is a heightened risk of heart attack and stroke from non-aspirin NSAIDS, referenced three years ago with an alert from the U.S. Food and Drug Administration. This Newsweek story briefly summarizes the issue.

Lack of current data on NSAIDs and seniors

Dr. M. Cary Reid, director of the Translational Research Institute on Pain in Later Life at Weill Cornell Medical College in New York, acknowledged that the data on harm from NSAID use is old, and there isn’t really any new good data on how many patients end up in the hospital because of OTC pain relievers, either alone or in combination with alcohol or stronger prescription medications.

“We know that there’s less opioid use going on, anecdotally, and we know more individuals with pain are turning to OTC non-prescribed treatments, but I’ve not seen a study on the impact of this shift,” he said.  

In his own practice, he said he’s seen “more renal impairment” based on lab values in his patients who use NSAIDS routinely.  “The rapid shift from opioids has caused massive uncertainty for physicians who don’t know what to do.”

Many seniors reach for their chubby bottles of Aleve or Advil, perhaps in jumbo sizes of 300 from Costco, on a daily basis. They may think nothing of it to prophylactically relieve any insults from their daily activities, and even give their stride some pep.

Reid thinks that’s not advisable.  He limits NSAIDs in his own practice to treating chronic flare ups from arthritis and other conditions with the expectation that patients are weaned off the medication a week or two. But they shouldn’t be used every day for no real reason.

Not every older person will experience an adverse event from non-steroidals, he emphasized. But for those that do, the symptoms may come on fast. Kidney function issues are usually seen early on.

More communication needed

Patients should tell their doctors about their OTC routines, which should prompt more frequent blood testing for signs of GI bleeding or kidney failure, Reid said.  In his practice, he sees patients with a mean age of 88, high levels of comorbidity and frailty, and he gets blood work at every visit.

More good studies are needed, and the data is especially sparse in the impact on older adults from over-the-counter NSAIDs in non-white seniors. 

Check the fine print for possible harms

The problem with OTC pain pills is also in the fine print. Dosage warnings are usually written in print too small to read, or peeling off part of the label and unfolding it to read all the contraindications (and two sets of glasses for seniors like me with seemingly worsening presbyopia). 

But those risks are there. Acetaminophen (Tylenol), one of the most widely used in this country, can lead to severe liver damage if more than 4,000 mg are taken in a day, and much less if other drugs are used at the same time. With “extra strength” Tylenol caplets of 500 mg, that’s eight a day. Tylenol recently reduced its recommended maximum dose to 3,000 mg per day. Or just three of its extended release, 650 mg tablets.

Many OTC analgesic products also come with warnings to avoid alcohol, as in this package warning on the Aleve website which says that risks of stomach bleeding are higher when users have three or more alcoholic drinks a day. It also made Prevention Magazine’s list of medications never to mix with alcohol.

Simple aspirin also has risks, and can provoke asthma symptoms and anaphylactoid reactions in sensitive patients.

Dr. Chad Brummett, associate professor of anesthesiology and the director of the Division of Pain Research at the University of Michigan Medical School, said that most non-steroidals are reasonably safe and effective.  But he too noted “serious consequences, including mortality associated with bleeding in the bowel.”

What seniors should recognize is that if they’re sensing GI system irritation or upset stomach, or serious gastroesophageal reflux disease (GERD), or heartburn, they should talk with their physician about extra monitoring. “The other issue with nonsteroidals is that you don’t want to take multiple types, say Motrin and Aleve. You don’t want to take two from the same category.”

Some clinicians interviewed for this tip sheet said they are concerned about websites that intentionally overstate the harm from non-steroidals, and do so with the intent of making opioids look safer or less concerning. 

But we don’t have 72,000 people a year dying from nonsteroidals, one noted.

The Medical Letter on Drugs and Therapeutics on Feb. 12 devoted its entire issue to the topic of dozens of non-opioid analgesics, from acetaminophen (sold as Tylenol), which is not an NSAID, to anti-seizure medications like gabapentin, to cannabis and cannabinoids.

For each product, the letter lists available dosages and usual dosages, comments and cost. For example, for naproxen sodium OTC generic (Aleve) by Bayer, which comes in 220 mg tablets, the usual dose is 220 mg every 8 to 12 hours, with a maximum of 660 mg per day.  And, 440 mg are said to be comparable to 400 mg of ibuprofen with longer duration.

The newsletter, which is available on subscription and for certain members of the media, devotes just one paragraph to nonpharmacologic therapies such as exercise, cognitive behavioral therapy, yoga, Pilates and tai chi.  While clinical trials with data comparing these approaches to placebo are scarce, the letter does say that exercise programs are unlikely to cause harm “and may be associated with improvements in pain severity and physical function.”

Sources

National Institute on Drug Abuse: Statistics and trends on overdose death rates

The U.S. Food and Drug Administration’s Safe Use Initiative.

The Medical Letter: Nonopioid Drugs for Pain (Feb. 12, 2018)

The Medical Letter: Comparison Table: Some Nonopioid Analgesics for Pain (online only.) (Feb. 12, 2018)

New England Journal of Medicine: NSAIDS Are A Major Cause of Anaphylaxis-related Emergency Department Visits. (Sept. 16, 2016)

Pharmaceuticals: Significant Acute Kidney Injury Due to Non-steroidal Anti-inflammatory Drugs: Inpatient Setting (April 26, 2010)

Lancet: Effects of aspirin on risks of vascular events and cancer according to bodyweight and dose: analysis of individual patient data from randomized trials (Aug. 4, 2018)

PLOS: Bleeding Risk with Long-Term Low-Dose Aspirin: A systematic Review of Observational Studies (Aug. 4, 2016)

British Journal of General Practice: High-risk use of over-the-counter non-steroidal anti-inflammatory drugs: a population based cross-sectional study (April, 2014)

British Journal of Clinical Pharmacology: Usage patterns of ‘over-the-counter’ vs prescription-strength nonsteroidal anti-inflammatory drugs in France (April 22, 2014)

American Journal of Managed Care: Quantifying the Impact of NSAID-Associated Adverse Events (Nov. 30, 2013)

Story ideas

• Check with your local emergency rooms or hospital systems to see if they’ve had reports of patients with OTC complications such as gastrointestinal bleeds or patients with kidney problems attributable to over-the-counter NSAIDS.

• Ask pharmacy chains or stores if they’ve seen an increase in sales of OTC pain relievers in the last year, or if they can say that patients are being switched to non-steroidal anti-inflammatory agents as a substitute for opioids.

• Interview area pain management specialists to see how they might recommend their patients treat their pain with over-the-counter products.

• Interview oncology specialists on how their prescribing practices for patients with cancer pain may have changed in light of the opioid epidemic.

Contacts

Cheryl Clark is a senior health care reporter for MedPage Today who has recently reported on a California effort to identify excessive opioid prescribers.