‘Pain is the most important symptom’: Helping patients navigate the dangers of OTC NSAIDs
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For patients with diseases such as lupus or rheumatoid arthritis who take low-dose drugs at lower frequencies, the relief afforded by over-the-counter drugs such as ibuprofen and naproxen can be a boon.
However, despite the sense among some patients that the wide and easy availability of certain OTC pain relievers may be a signal that these drugs are by default safer than many prescription therapies, the truth is that the use of NSAIDs requires careful moderation to avoid some of its most serious side effects. For patients with rheumatic diseases who rely on higher prescription doses at more frequent intervals in particular, the risks associated with self-medicating with NSAIDs can be fraught.
That said, it is easy to understand why these patients might gravitate toward available OTC medications. The answer, according to the physicians who care for these patients, can be summed up in one word: Pain.
“Pain is the most important symptom to patients — we all know this,” John Tesser, MD, FACR, of the University of Arizona Health Sciences Center, told Healio. “Pain is a very complicated beast that we have recognized for a long time.”
That drive to relieve pain, coupled with the availability of certain NSAIDs without a prescription may lull patients into a false sense of security while using these drugs, according to experts. However, this type of use, and sentiment, can be dangerous.
“People think drugs you can get over the counter are safer than things that are not over the counter, that are prescriptive,” Lee Simon, MD, MACR, FACP, the former division director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products at the FDA, told Healio.
Meanwhile, the ease of access intrinsic to OTC medication is not the only driver of their use. Many patients can face diagnostic delays that can be measured in years for a variety of reasons, including the omnipresent workforce shortage in rheumatology and the often difficult-to-nail-down nature of certain rheumatic diseases.
These delays — in both diagnosis and treatment — can shepherd patients to their local pharmacy’s OTC aisle, where the convenient availability of NSAIDs and other pain relievers can be a welcome alternative to finding a rheumatologist.
“In terms of autoimmune diseases like RA and lupus, or any of the related conditions, that delay of getting to a rheumatologist is certainly an issue with patients taking these things,” Tesser said. “And I think the issue is the delay. They got to get their RA or lupus diagnosed. We're on better disease modifying medicines that may take care of their pain, that may obviate their need to take NSAIDs over the counter.”
Gastrointestinal issues
Before his time with the FDA, Simon sat as a voting member on the advisory committee regarding the OTC availability of ibuprofen. At that time, he voted against making ibuprofen freely available because of the potential risks it can pose to patients.
“One percent to 3% of patients who take nonsteroidals will develop elevations in their blood pressure,” Simon said.
In patients who are already hypertensive, this has the potential to counter any medications that keep hypertension under control, according to Simon. In addition, there is a potential for gastric complications and other adverse events.
“The incident rate of gastrointestinal bleeding with these drugs is variable, but it is not impossible,” Simon said. “Depending on how much you take, and for how long, it is clear that there is an increased risk for GI bleeding and death.”
This concern for gastric irritation and bleeding was shared by other rheumatologists.
“With NSAIDs, for example, some of the things we worry about are things like getting stomach ulcerations, gastritis, or irritation of the stomach lining,” Bryant England, MD, PhD, an associate professor in the division of rheumatology at the University of Nebraska College of Medicine, told Healio. “Most of the time, this causes upset stomach or discomfort, but sometimes it can cause severe bleeding in the stomach or intestines.”
Aside from potential complications including hypertension and gastric events, sustained use of high-dose NSAIDs can damage the kidneys.
“Another thing that we are careful of with nonsteroidals is kidney function,” England said. “Taking NSAIDs for a long time at a higher dosage can impact the kidneys, which can be problematic.”
Because of the dangers of unrestricted NSAID use, rheumatologists can, and should, coordinate with other relevant specialties to ensure that patients are being monitored for complications, and that patients are seen as quickly as possible.
‘A good working relationship’
In a health care landscape rife with workforce shortages, it is probable that patients will inevitably encounter long waits for appointments. In dire cases, it is critical for physicians across specialties to work together to ensure that patients seen as soon as possible, according to England.
“It’s important for primary care providers and rheumatologists to have a good working relationship,” England said.
There may be times when a critically ill patient with a rheumatic disease makes it into the primary care office but the wait for a rheumatologist is not feasible. In these cases, England said PCPs can, and should, reach out to their rheumatologist colleagues and attempt to schedule an appointment on a shorter timetable.
“Based on those patients’ symptoms or the evaluation they have had thus far, if it is not appropriate to wait 6 months, that this is a condition or disease where we call their office,” England said. “And as his rheumatologist, would say, ‘Absolutely.’”
Once the patient has made it into the office, it becomes the responsibility of the rheumatologist to counsel them on ways they can safely use OTC medications in concert with any prescription therapies intended to modify disease activity.
'You don’t just want to reduce the pain’
When a patient with RA or osteoarthritis makes it to the rheumatologist, said rheumatologist must determine which therapies have the highest probability of delivering success.
However, there are some cases where patients have found prior success with an NSAID and may be reluctant to drop it.
“I think the most important part is to explain that you don’t just want to reduce the pain — you want to understand what the disease is,” Simon said. “And if it's an inflammatory arthritis, such as rheumatoid arthritis, ankylosing spondylitis and systemic rheumatic disease, you sit down and talk to them about disease-modifying drugs, and how one would use those. But it’s not possible, in most circumstances, to stop the nonsteroidals.”
According to Tesser, this is where shared decision-making plays a role.
“This has to be shared decision-making,” he said.
If a physician tells a patient that they simply will not recommend or prescribe high levels of nonsteroidals, the patient may look elsewhere for care or buy an OTC drug on their own. As a workaround for the truly diehard patients, Tesser said he often offers a compromise — reducing the number of days where the patient takes ibuprofen, and increased monitoring for any side effects the patient may be at risk for.
“I tell the patient to try acetaminophen on most days and then take some ibuprofen as relief on the days you hurt the most,” Tesser said. “Most patients can get by with that.”
However, all the best counsel in the world may be of little use if the physician fails to understand how their patient uses OTC drugs at the time they present for a visit.
“I try to talk with them about really understanding how they are using it right now, and making sure it is very clear what their dose and frequency are, and whether they are taking multiple kinds of NSAIDs,” England said.
He added that, in many cases, patients are unaware that they should refrain from taking more than one kind of NSAID at a given time. Thus, it is essential that rheumatologists ensure patients understand they should not be taking ibuprofen and naproxen, for instance, at the same time. Following initial counseling, England said he recommends setting proper expectations for the future, and what the patient’s relationship with NSAIDs should look like after an appropriate disease-modifying antirheumatic drug is prescribed.
Such expectations can include advice about which specific OTC NSAIDs may be preferable over others.
According to Simon, patients looking for OTC pain relief when experiencing OA symptoms should consider topical nonsteroidal agents before oral options.
“Almost all of the guidelines out of the American College of Rheumatology, the Arthritis Foundation and the Osteoarthritis Research Society International all suggest trying topical nonsteroidals before oral systemic nonsteroidals,” Simon said.
However, depending on the disease state, he cautioned that topical agents may not be up to the task.
For patients who are relying on NSAIDs or other OTC drugs to manage their chronic pain for these types of conditions, it is important to recognize that there is no silver bullet, Tesser said.
“When you’re discussing oral medication, this is kind of where we are at, and it is not great,” he said. “Especially for chronic pain, they aren’t that great.”
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