Some recognizable examples of Nonsteroidal anti-inflammatory drugs (NSAIDs) include ibuprofen (Advil, Motrin), diclofenac, and naproxen (Aleve). They are frequently used as the first line of defence to reduce pain and inflammation. Most NSAID medications are available without a prescription and are widely used to reduce fever and pain related to long- and short-term medical conditions such as headaches, arthritis, menstrual cramps, and flu symptoms. However, just because they are available without a prescription does not mean that they are 100% safe. New labeling requirements have raised awareness of potential risks for the estimated 30 million Americans taking nonsteroidal anti-inflammatory drugs each year.
The Food and Drug Administration has recently strengthened its warning on NSAIDs due to recent studies that shows even small amounts of NSAIDs present a risk of heart attack, heart failure, or stroke. The updated warning is a result of a growing body of research into these widely used over the counter (OTC) drugs. While it was always presented as a risk, the new strengthened warning clarifies that NSAIDs may increase the risk of heart attack or stroke in all patients, with or without heart disease or risk factors for heart disease as previously thought. Those with risk factors of heart disease should be particularly cautious because they are already at a higher baseline for such complications. The FDA will require new labels to reflect this developing research.
Should you worry? Not if you are using these medications as directed. There seems to be a consensus from the medical community that more studies are needed before we empty out our medicine cabinets. Bruce Lambert, director of the Center for Communication and Health at Northwestern University, who specializes in drug safety communication shared his comments with the New York Times, “One of the underlying messages for this warning has to be there are no completely safe pain relievers, period.” Another article for NPR highlights the general rule of using caution with any medication.
Although the FDA’ s new warnings need not cause alarm, the announcement is an important reminder to the millions of people that use NSAIDs on a daily basis that misuse or overuse of OTC drugs could result in severe health consequences. Patients that rely on these OTC painkillers long term should talk to their health care providers about reasonable alternatives.