New warning label coming for popular pain relievers

FDA wants to include updated information on heart attack, stroke risk


The warning label on some of the most-used pain relievers on the market will be changing in the coming months. The Food and Drug Administration will require manufacturers to provide more specific information about heart attack and stroke risks associated with non-steroidal anti-inflammatory drugs, also known as NSAIDs.

"The FDA is increasing the strength of the warning based upon analysis of observational studies, not studies of the highest quality, which are randomized controlled clinical trials, but they're being cautious. That caution is reasonable," said Cleveland Clinic Cardiologist Dr. Steve Nissen.

The updated labels will pertain to both prescription and over-the-counter NSAIDs. It will contain information about the increased chance of heart attack or stroke, which can occur as early as the first few weeks of using an NSAID.

If you already have heart disease, recently suffered a heart attack, or underwent heart bypass surgery - you're at the greatest risk of suffering adverse events associated with this type of pain reliever.

FDA researchers say to read the drug facts label carefully, take the lowest effective dose for the shortest amount of time, and be careful not to take more than one product that contains an NSAID at a time. Nissen says it's important to know the risks.

"If you're somebody that has a low risk of heart disease and you have back pain or arthritis pain and you need these drugs to function, it's reasonable to take them but there is probably some increase in risk in heart disease and the public needs
to be aware of that," explained Nissen.

For more information on the new warning labels, go to FDA.gov.