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Preventive Cardiology Clinic

FDA Strengthens Risk Warning on Popular Pain Medications: What You Need to Know


This week the FDA mandated that all non-steroidal anti-inflammatory drugs (NSAIDs) carry a stronger warning about the increased risk of heart attack and stroke during use. Given that 29 million Americans use these drugs regularly, that’s a pretty important development. So what do you really need to know?

1. Understand what a NSAID is. This is a group of medications typically used to treat pain and inflammation. Common over-the-counter brands are Advil, Motrin (ibuprofen), and Aleve (naproxen). Common prescription NSAIDs include Celebrex (celecoxib), Disalcid (salsalte), Indocin (indomethacin), Toradol (ketorolac) and Voltaren (diclofenac). There are many other prescription NSAIDs. Chances are good that you’ve taken one of these medications at some point in your life.

2. Understand what a NSAID is not. Tylenol (acetaminophen) is not a NSAID and is not covered by the FDA warning. Although aspirin does have anti-inflammatory properties, it is also not included in the FDA warning.

3. Understand who is at risk. Anyone who is using a NSAID medication is at higher risk of developing a heart attack or stroke. Individuals at especially increased risk are those with known heart disease, history of heart attack or stroke, and those with risk factors for heart disease including smokers, diabetics, people with high blood pressure and/or high cholesterol. Those using higher doses of NSAIDs for longer periods of time are at higher risk but even short duration, low dose use can be problematic.

4. Understand how to minimize your own risk. The obvious answer is to use these medications sparingly. For mild pain, consider Tylenol or aspirin instead. If you do need to use NSAIDs, use the lowest possible dose for the shortest possible time. And be sure to address any heart disease risk factors you may have – make yourself a lower risk NSAID user.

5. Understand when to seek medical attention. Always take new symptoms such as chest pain, shortness of breath, weakness , speech or vision problems seriously.

6. Keep it in perspective. These medications have been around for decades. That does not make them automatically safe, but many people have taken these drugs without any problems. Still, the FDA warning should serve as a reminder to us all that medications come with risks and we should be minimizing their use.

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