Dr. Campbell: FDA changes warnings on ibuprofen and other NSAIDs


RALEIGH, N.C. (WNCN) – For the last several years, the FDA has warned that ibuprofen, Naproxen and other NSAID-type painkillers may cause an increased risk for heart disease and stroke.

Now the FDA has strengthened its warning for these drugs and says that these agents absolutely do raise the risk for heart attack and stroke.

The FDA said it reviewed a large number of studies that supported the conclusion that the medicines caused increased risk. The studies estimated that the relative risk increased by 10 percent to 50 percent, depending on the drugs and the doses considered.

The new FDA warning covers drugs called nonsteroidal anti-inflammatory drugs or NSAIDS for short. They include ibuprofen, sold under brand names like Advil or Motrin; naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors, such as Celebrex.

Ibuprofen and other NSAIDs work by inhibiting production of prostaglandins-(by inhibiting an enzyme called cyclooxygenase). Prostaglandins are chemicals released by injured cells that trigger inflammation and pain. It is important to remember that Tylenol, known generically as acetaminophen, is not an NSAID and works in a different way. It is not included in this new FDA warning. Tylenol also has potential health risks and this includes liver damage and toxicity when taken in very high doses.

Prescription NSAIDs are an important treatment for the symptoms of many debilitating conditions, including arthritis, rheumatoid arthritis‎, gout and other rheumatological conditions.

NSAIDs are used to temporarily reduce fever and to treat minor aches and pains such as headaches, toothaches, backaches, muscular aches, tendonitis, strains, sprains and menstrual cramps.

Remember that in addition, some combination medicines that relieve various symptoms, such as multi-symptom cold products, contain NSAIDs.

According to an FDA spokesman, the “FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) drug facts labels to indicate that non-steroidal anti-inflammatory drugs can increase the chance of a heart attack or stroke, either of which can lead to death.”

The FDA has carefully reviewed the data for the last year and has found that in numerous studies it has been clear that the use of NSAIDS is associated with an increased risk for heart disease and stroke.

Some of the studies they looked at showed a clear pattern: people who took NSAIDS were more likely to have heart attacks or strokes. Many of the researchers found that the time course of the development of heart disease can be both early and late in the course of starting NSAIDS.

The FDA added a boxed warning to prescription drug labels for the increased risk for heart disease and stroke in 2005. More recent data has now prompted the FDA to update NSAID labeling.

Today we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks. People who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for cardiovascular adverse events associated with NSAIDs. This particular population is at very high risk-they are quite vulnerable and should avoid NSAIDs when possible.

The bottom line is that NSAIDs are effective treatments for pain, inflammation and fever.

Consumers can still take them but should be aware of this increased risk of heart attack or stroke, especially at higher doses.

If you have heart disease or high blood pressure, talk with your doctor before using an NSAID.

Together, with your doctor, you must balance the benefits of NSAIDs with the possible risks.

Seek urgent medical attention and stop taking NSAIDs if you experience symptoms that might signal heart problems or stroke — chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech. If you take these drugs, take the smallest effective dose.

To get in touch with Dr. Campbell, you can head to his website, Facebook page or message him on Twitter.

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