FDA strengthens warning that NSAIDs increase heart attack and stroke risk
Back in 2005, the FDA warned that taking nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen increased the risk of having a heart attack or stroke. In July 2015 the FDA took the unusual step of further strengthening this warning. This was done on the advice of an expert panel that reviewed additional information about NSAIDs and their risks. Because ibuprofen (Motrin, Advil) and naproxen (Aleve) are available over-the-counter and so widely used, it’s important to be aware of the ibuprofen warnings and naproxen warnings and to take steps to limit the risk.
Many people take NSAIDs to relieve mild to moderate pain. These medications may be particularly effective in conditions in which pain results primarily from inflammation, such as arthritis or athletic injury. While you can buy ibuprofen and naproxen on your own, doctors commonly write prescriptions for celecoxib (Celebrex), diclofenac (Cataflam, Voltaren) and other NSAIDs. Aspirin is also an NSAID, but it does not pose a risk of heart attack or stroke. In fact, aspirin is commonly used to prevent heart attacks and strokes. So, it is not covered by this warning.
NSAIDs may also elevate blood pressure and cause heart failure. The risk of heart attack and stroke achieved special notoriety with rofecoxib (Vioxx), a type of NSAID called a COX-2 inhibitor. It caused as many as 140,000 heart attacks in the U.S. during the five years it was on the market (Vioxx was removed from the market in 2004). The regrettable experience with Vioxx raised awareness about the cardiovascular risk of NSAIDs, and led to further studies showing that the risk is not limited to Vioxx but is associated with all NSAIDs.
The FDA has noted the following ibuprofen warnings and naproxen warnings along with similar risks of other NSAIDs:
- Heart attack and stroke risk increase even with short-term use, and the risk may begin within a few weeks of starting to take an NSAID.
- The risk increases with higher doses of NSAIDs taken for longer periods of time.
- The risk is greatest for people who already have heart disease, though even people without heart disease may be at risk.
Using NSAIDs safely
Taking an NSAID for a headache, or for a few days to ease a sore shoulder isn’t likely to cause a heart attack or stroke. It’s more prolonged use that can get risky.
In view of the warnings, it is best for people with heart disease to avoid NSAIDs if at all possible, and for everyone who is considering taking an NSAID to proceed with caution. Here are some strategies:
- It’s important to take the lowest effective dose, and limit the length of time you take the drug.
- Never take more than one type of NSAID at a time. There appears to be risk associated with all types of NSAIDs.
- Try alternatives to NSAIDs such as acetaminophen. It relieves pain but does not appear to increase heart attack or stroke risk. However, acetaminophen can cause liver damage if the daily limit of 4,000 milligrams is exceeded, or if you drink more than three alcoholic drinks every day.
- If nothing else works and you need to take an NSAID for arthritis or other chronic pain, try taking week-long “holidays” from them and taking acetaminophen instead.
- If you experience chest pain, shortness of breath, or sudden weakness or difficulty speaking while taking an NSAID, seek medical help immediately.
By Gregory Curfman, MD
Assistant Professor of Medicine | Former Editor-in-Chief, Harvard Health Publishing