Risk Revised: FDA Cautions on NSAID Use

Government strengthens its warnings for nonsteroidal anti-inflammatory drugs


Hammer Peak Performance Tip: Many athletes routinely use ibuprofen and other nonsteroidal anti-inflammatory drugs to alleviate pain and inflammation. The FDA now warns that even short-term use of these drugs is dangerous. Don't risk your health with NSAIDs; Tissue Rejuvenator helps ease inflammation and soreness naturally and effectively without NSAID side effects. Read on for details.

Ibuprofen use among endurance athletes is so ubiquitous that many even jokingly refer to the painkiller as "Vitamin I."

The U.S. Food and Drug Administration, however, warns that NSAID (nonsteroidal anti-inflammatory drug) use is no laughing matter, cautioning that these drugs are deadly serious. This summer the government agency strengthened its warning that NSAIDs can increase the risk of heart attack and stroke, saying that the risk is much greater than it had previously disclosed. The warning covers both prescription NSAIDs as well as over-the-counter products such as ibuprofen and naproxen (but does not include aspirin). Read the updated label warnings below.

"There is no period of use shown to be without risk," Judy Racoosin, M.D., M.P.H., deputy director of FDA's Division of Anesthesia, Analgesia, and Addiction Products states in a news release.

Racoosin goes on to state that healthy people aren't immune to the dangers of NSAIDs. "Everyone may be at risk - even people without an underlying risk for cardiovascular disease."

The take-home message: These powerful painkillers do not belong in your race bag. For those who may find these new warnings "overblown" and may be tempted to still reach for their "Vitamin I," medical experts implore them to reconsider.

"One of the underlying messages for this warning has to be there are no completely safe pain relievers, period," Bruce Lambert, director of the Center for Communication and Health at Northwestern University told the New York Times in July. "I don't think we will ever see a study that says, 'Oops, NSAIDs were safe after all.' "

Tissue Rejuvenator - a safe, natural alternative

Tissue Rejuvenator can help your body quell inflammation, repair tissue, and increase mobility safely, naturally, and effectively. Tissue Rejuvenator is also ideal for helping to protect against joint-related injuries, and recovering from them.

The Tissue Rejuvenator formula includes:

  • Glucosamine sulfate - a building block for repairing damaged cartilage; also promotes joint movement and acts as a mild anti-inflammatory
  • Chondroitin sulfate - helps repair and protect cartilage; promotes joint lubrication and cushioning
  • Methylsulfonylmethane (MSM) - an organic form of sulfur, which is needed to maintain tendon and cartilage tissue; reported to reduce arthritis pain and enhance wound healing
  • Turmeric, boswellia, yucca root, and devil's claw - compounds in these herbs appear to have potent anti-inflammatory and/or anti-arthritic properties

Read the complete nutrient profile and benefits of Tissue Rejuvenator.

The FDA's strengthened NSAID label warnings

  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
  • The risk appears greater at higher doses.
  • It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
  • In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
  • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
  • There is an increased risk of heart failure with NSAID use.


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