For the last several years, the FDA has warned that ibuprofen, naproxen, and other non-steroidal anti-inflammatory drugs (NSAIDs) many cause an increased risk for heart disease. And just last week, the FDA strengthened its warning that these drugs raise the risk for heart attack and stroke.
NSAIDs work by inhibiting the production of chemicals called prostaglandins, which are released by injured cells, triggering an inflammatory response. It is this response that causes pain and redness in the affected tissue.
It is important to remember that Tylenol, known generically as acetaminophen, is not an NSAID, and works in a different way. Therefore, it is not included in this new FDA warning.
Unfortunately, acetaminophen has potential health risks and side effects of its own — mostly liver damage and toxicity when taken in very high doses.
The FDA has warned consumers about the potential association between heart disease and the use of NSAIDs since 2005, and labeling changes and black box warnings required manufacturers to list heart problems as a potential side effect.
After a thorough review of data over the last year, the agency has now determined that the use of NSAIDS is clearly associated with increased risk for heart attack and stroke. Studies conducted in numerous locations around the world estimated a relative risk of 10 to 50 percent, depending on which drug and what dose was taken.
Even more concerning is the fact that the increased risk for heart disease was found to occur both early and late in the course of treatment with an NSAID.
Certainly, people who already have heart disease — particularly those who have recently suffered a heart attack or undergone cardiac bypass surgery — are at the greatest risk for adverse cardiac events associated with NSAIDs. They should avoid NSAID pain relievers whenever possible.
As with most things in medicine, we must weigh the risks and benefits of any treatment plan or therapy. Ideally, doctors discuss these risks and benefits carefully with a patient and his or her family so that everyone understands the goals and risks of therapy.
While we know that NSAIDs are effective treatments for pain, inflammation, and fever, it is clear that they may cause cardiovascular disease in predisposed patients. Therefore, it is essential that both patients and healthcare providers are aware of these new warnings by the FDA.
Patients with increased risk should minimize dosages as well as length and frequency of therapy when possible. And if you have heart disease or high blood pressure, it is very important that you talk with your doctor before using any over the counter NSAID.
Consumers must be aware that many over-the-counter remedies contain a combination of drugs — including NSAIDs — and it is vital to read labels to know exactly what you are taking.
If you chose to take NSAIDs for pain relief, be aware of the signs and symptoms of heart attack and stroke, including chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech. If you have any of these symptoms, seek immediate medical attention and stop taking NSAIDs right away.
If you and your doctor decide that it is acceptable to take these drugs, take the smallest effective dose and limit the course of therapy to the shortest effective treatment time.
Posts by Kevin R. Campbell, M.D.
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