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Many Pain Patients Risking OTC Overdoses

January 28, 2016
American Gastroenterological Association survey shows that consumers do not follow labels when taking over-the-counter pain medications (Advil, Motrin, Tylenol), putting them at increased risk for adverse events.

Many chronic pain patients who use over-the-counter (OTC) medicines "are routinely ignoring medicine labels," according to physician and consumer surveys released by the American Gastroenterological Association (AGA).1

Pain patients taking either OTC or prescription versions of nonsteroidal anti-inflammatory drugs (NSAIDs) should be aware of adverse events associated with these commonly used medications, especially if you have pre-existing cardiovascular conditions or history of gastrointestinal bleeding and patients taking acetaminophen should be warned about possible liver toxicity with overuse.

“Pain is incredibly personal, but taking more than the recommended dose of OTC pain medicine can cause significant stomach and intestinal damage among other complications,” said Byron Cryer, MD, councillor-at-large, AGA Institute and associate dean, The University of Texas Southwestern Medical Center, Dallas, in a press release from AGA.

AGA commissioned the Gut Check: Know Your Medicine survey, conducted online by Harris Poll in September-October 2015 among 1,015 U.S. adults aged 30+ (“consumers”) and 251 U.S. gastroenterologists, and said the issue is concerning because chronic pain affects about 100 million American adults, according to a 2011 Institute of Medicine report. 

Key findings include:

  • Many gastroenterologists report a majority of their chronic pain patients are using medicines at a higher dose and for a longer duration than recommended and often don’t connect the overdose symptoms to the OTC pain medicines. 
  • Most chronic pain sufferers (66%) have been experiencing pain for 2 years or more, though only about 1 in 10 (12%) have been diagnosed with chronic pain by a health-care professional.  
  • More than 2 in 5 (43%) chronic pain sufferers said they knowingly have taken more than the recommended dose at some point.
  • Many chronic pain sufferers believe the directions on the labels of OTC pain medicine are really just guidelines — stating they know what works best for them (43%).
  • Many consumers do not know that combining 2 or more NSAID (38%) or 3 or more acetaminophen (Tylenol) products (38%) increases the risk of serious health complications when taking OTC pain medications.

FDA Increased Warnings

In 2015, the FDA strengthened the warning on prescription and OTC labels that "NSAIDs  can increase the chance of a heart attack or stroke, either of which can lead to death."2

Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech, noted the agency.

These serious side effects can occur as early as the first weeks of using an NSAID and the risk may increase the longer a patient is taking an NSAID. The risk appears greater at higher doses; therefore, advise patients to use the lowest effective amount for the shortest possible time.

Many medicines contain NSAIDs, including those used for colds, flu, and sleep, so it is important to remind patients to read the labels and avoid taking multiple medicines that contain NSAIDs.

Patients who take low-dose aspirin for protection against heart attack and stroke, should be told that  some NSAIDs, including those in OTC products such as ibuprofen and naproxen, can interfere with that protective effect.

GI Bleeding

According to the literature, there is a 25% chance (risk) that a patient will develop some type of ulcer while taking an NSAID.3 This is especially true in patients who chronically take oral non-selective NSAIDs.

The risk of GI bleeds appears to be highest with ketorolac, and then in decreasing order, piroxicam, indomethacin (Indocin, others), naproxen (Aleve), ketoprofen, meloxicam (Mobic, others), diclofenac (Voltaren, Solaraze, others), and ibuprofen (Advil, Motrin, others). The first 5 NSAIDs are more cyclooxygenase (COX)-1 selective, meloxicam and diclofenac are more COX-2 selective, and ibuprofen is non-selective.4,5

The AGA advises physicians aqnd patients to:

  • Talk about all the medicines patients are taking (OTC and prescribed). 
  • Read and follow all medicine labels
  • Only take one product at a time containing the same kind of ingredient.

For an executive summary of the survey findings and to learn more, visit

Last updated on: January 29, 2016
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