FDA to Require Stronger Cardiac Risk Warnings on All Non-aspirin Pain Relievers

“Should you take painkillers?” was the question recently posed by The Washington Post front page after the FDA announced strengthened safety warnings on all over-the-counter (OTC) and prescription non-aspirin inflammation and pain relievers known as NSAIDs (non-steroidal anti-inflammatory drugs). The FDA will require makers of widely-used prescription and over-the-counter NSAIDs such as Advil and Motrin (ibuprofen) and Aleve (naproxen), commonly used to treat pain, fever and inflammation, to change their labeling to reflect stronger warnings about the increased risk of heart failure when using these medicines.

New FDA labeling changes will require all OTC and prescription NSAID drug makers to provide more information about the increased risk of heart attack and stroke when using NSAIDs. This class of drugs has carried warning labels since 2005 about the increased risk of heart attack and stroke with long-term use, but the FDA decided to require labeling changes after new research revealed NSAIDs can cause serious side effects after shorter periods of use, within the first few months, and at smaller doses and the new labeling requirements will reflect this increased risk. The warning language will be more forceful changing from “may cause increased risk of heart attack and stroke” to “cause.” Use of as little as 3 times a week for more than 3 months increases the risk of heart attack and stroke by 41%.

As you might expect, people at the greatest risk for heart attack and stroke are those who already have a prior cardiac history so the FDA plans additional warnings for people who have already had a heart attack or cardiac bypass surgery that their use of NSAIDs may make them more susceptible to suffering another heart attack. But don’t take solace if you’ve never had cardiac problems. Even if you have no cardiac history, and have only taken NSAIDs a short while, you still may be at increased risk. Dr. Judy Racoosin, FDA Deputy Director of Anesthesia, Analgesia and Addiction Products, cautions, “There is no period of use shown to be without risk. Everyone may be at risk, even people without an underlying risk for cardiovascular disease.”

NSAIDs serve a useful purpose but must be used with caution. When using any type of NSAID or medication that contains it, it is important to be your own health advocate through communication with healthcare providers, and personal observation about how you’re feeling.

The FDA makes the following recommendations regarding NSAID use:

  • If you have high blood pressure or heart disease, talk to your doctor about the risks and benefits before using NSAIDs.
  • Find out your risk factors for heart attack and stroke including high blood pressure, high cholesterol or diabetes, work to get these under control, and stop smoking if you are a smoker.
  • Read all labels and any Drug Facts literature before taking any medicines. If you’re already taking NSAIDs, be very cautious about drug interactions and unintentional overdose on NSAIDs when taking other medicines. Many drugs used to treat colds or flu also contain NSAIDs so if your cold or flu medicine also contains ibuprofen or naproxen, do not take any additional type of NSAIDs.
  • Do not to take more than one pain reliever at the same time with the same ingredient.

The FDA advises that NSAIDs are still okay to take for short periods of time, for the temporary relief of inflammation or pain, but only take the smallest dose for the shortest possible duration and do not take more than one NSAID at a time. If you are taking NSAIDs in any form, be aware of problems such as chest pain; trouble breathing; or any signs of a stroke like slurred speech, inability to talk or smile, or sudden weakness on one side of the body. If you experience any of these symptoms, stop taking NSAIDs and seek immediate medical attention.

You can find the complete FDA Consumer Bulletin here: www.fda.gov/consumers/consumer-updates/fda-strengthens-warning-heart-attack-and-stroke-risk-non-steroidal-anti-inflammatory-drugs