What Does the New NSAID Label Warning Mean for Workers’ Comp?

by Sam Aminov
PharmD, MBA

FDA Strengthens Label Warning on NSAIDs

In a recent Drug Safety Communication, the U.S. Food and Drug Administration (FDA) strengthened an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke[i]. The cardiovascular risks of NSAIDs were first described back in 2005. A comprehensive review of new safety information prompted the FDA to require drug manufacturers for both OTC and prescription NSAID products to change their labeling to reflect the increased cardiovascular risk.


NSAIDs are typically prescribed for pain and inflammation from a variety of causes, and have been used by millions of consumers for decades. Some of the more common OTC products include ibuprofen (Advil®, Motrin®) and naproxen (Aleve®). These are also available by prescription in higher doses, in addition to prescription only NSAIDs including celecoxib (Celebrex®) and meloxicam (Mobic®).

The FDA’s recent Safety Announcement states, “prescription NSAID labels will be revised to reflect the following information:

The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.

The risk appears greater at higher doses.

It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.

Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.

There is an increased risk of heart failure with NSAID use.”

The FDA will also be requesting “similar updates to the existing heart attack and stroke risk information in the Drug Facts labels of OTC non-aspirin NSAIDs.”

Concerns for Workers’ Compensation


The FDA communication raises a valid concern for workers’ compensation. Chronic opioid utilization has been under scrutiny and the target of many clinical initiatives across the industry. Is it possible now that new data on NSAIDs points toward opioids as the safer option for treating pain? Unfortunately, there is not a black and white answer to this question and there is no gold standard for treatment with NSAIDs. NSAIDs and acetaminophen have been used for decades in combination products with opioids both for their therapeutic effects and to curb and deter opioid abuse. However, ceiling dose and other safety concerns have resulted in the rise of new opioid formulations with standalone opioid products and combinations with smaller amounts of acetaminophen.

What is widely known and well documented are the inherent risks associated with chronic opioid use. It is possible that the updated label language for NSAIDs will change prescribing habits and result in an increase in opioid prescriptions. This unfortunately would exacerbate the problem of chronic opioid use seen in workers’ comp, and emphasis should be placed on putting the FDA warnings into context. It seems that the updated label language would confuse, not help matters. It is also important to realize that there are legal reasons these labels exist.

Putting the New Labeling in Perspective

The fact remains that NSAIDs have been used safely for many years.

It has long been known that NSAIDs can increase the risk of stroke and heart attack.

All medicines have potential adverse effects, and patients together with their clinicians need to assess the risks and benefits of all treatments.

In many cases, the benefits of NSAIDs still outweigh the risks, especially when used as an alternative to chronic opioid therapy.

This is not meant to discredit or lessen the severity of the FDA warnings. Treatment plans need to be individualized to each patient, and there needs to be a continued focus on curbing chronic opioid use and enhancing patient safety.

[i]Food and Drug Administration [Internet]. Silver Spring, MD. FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm. Accessed July 13, 2015