The FDA recently issued notices for prescription drug labels and over-the-counter (OTC) Drug Facts labels regarding non-steroidal anti-inflammatory drugs (NSAIDs), which can increase the risk of stroke, heart attack and even death. These side effects can occur in the first weeks of taking an NSAID, and the risk might be elevated the longer people use them. (Aspirin is an NSAID, but the warning is not applied to aspirin products.)
OTC drugs are utilized for temporary relief of fever and pain. The drugs in this group address common, various painful conditions, such as arthritis. Since many prescription and OTC medicines include NSAIDs, patients should try not to take multiple remedies with the same active ingredient at the same time.
The NSAIDs and OTC NSAIDs labels already have info on stroke and heart attack risk. Now, the FDA will demand that manufacturers of NSAIDs update their labels with more detailed data on heart attack and stroke risks.
“There is no period of use shown to be without risk,” warned Judy Racoosin, director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.
Those with cardiovascular disease, especially those who had a heart attack or cardiac bypass surgery recently, have higher risks for NSAIDs’ adverse cardiovascular events.
The FDA is also including more information in the drug label for those who already suffered from heart attack. This group is more vulnerable and have higher odds of having another heart attack and of dying if treated with NSAIDs.
Those without cardiovascular disease might be at risk as well. “Everyone may be at risk — even people without an underlying risk for cardiovascular disease,” Racoosin noted.
Mahoney said: “As always, consumers must carefully read the Drug Facts label for all nonprescription drugs. Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed. Take the lowest effective dose for the shortest amount of time possible.”
It is important to read the consumer-friendly Medication Guide that comes with the prescription and, in case of heart disease or high blood pressure, go to a healthcare provider before using an NSAID and stop using it in case of experiencing symptoms that might be related to stroke or heart problems such as trouble breathing, chest pain, sudden weakness in one part or side of the body, or sudden slurred speech.