FDA strengthens warning on NSAID labels

July 10, 2015

Eugene, Ore. — The U.S. Food and Drug Administration announced that it is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of heart attack or stroke. The new policy pertains to both over-the-counter and prescription NSAID labels.

The FDA reached its decision to strengthen NSAID warning labels following a comprehensive review of new safety information, including that risk of heart attack and stroke appear to increase with longer use of NSAIDs and / or at higher doses. This review emanated from a 2014 joint meeting of the Arthritis Committee and Drug Safety and Risk Management Advisory Committee.

The Alliance for Rational Use of NSAIDs executive director Jennifer Wagner, LPN, and chairperson Byron Cryer, MD, presented at the aforementioned meeting. The change by the FDA highlights the need for a broader discussion on safe and appropriate used of NSAIDs.

“This announcement of stronger warning labels on NSAID products is a reasonable approach towards raising awareness of their associated risks,” said Cryer. “However, while this new policy specifically addresses cardiovascular risks, it’s important to note that renal and gastrointestinal complications can also result from NSAID use.”

“The safest and most appropriate way to take an NSAID is at the lowest dose for the shortest duration for a desired therapeutic effect,” said Cryer, who is an associate dean at The University of Texas Southwestern Medical Center. “And of course, it is always important to read medication labels and know what you are taking.”

The Alliance has declared NSAID Awareness Week for August 24-28, during which the Alliance will raise awareness about these drugs and how to use them safely through educational content published across its various media platforms. These materials will also be made available through its partner organizations.


ABOUT: The Alliance for Rational Use of NSAIDs is a public health coalition dedicated to the safe and appropriated use of non steroidal anti-inflammatory drugs (NSAIDs).


This information is intended for educational purposes only and should not replace the care of your health care provider.
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