Tag Archives: NSAIDs

celebrex safety label

FDA Advisory Panel Recommends Softening “Celebrex” Safety Labeling

A U.S. Food and Drug Administration (FDA) advisory panel concluded that prescription pain medication celecoxib (Celebrex), marketed by Pfizer, is as safe as other common nonsteroidal anti-inflammatory drugs (NSAIDs) when it comes to cardiovascular (CV) risks. The panel recommended updating the medicine’s safety labeling to reflect that.

Celecoxib is a selective COX-2 inhibitor, which means it blocks production of an enzyme associated with inflammation. “Nonselective” NSAIDs, such as naproxen and ibuprofen, block both COX-1 and COX-2; by blocking COX-1, they give rise to gastrointestinal (GI) side effects. Celecoxib is often prescribed to patients with osteoarthritis (OA) or an inflammatory type of arthritis, such as rheumatoid arthritis (RA), especially those who are at higher risk of GI side effects.

But its cardiovascular safety profile has been under a cloud of suspicion for more than a decade, after two other COX-2 inhibitors were pulled from the U.S. market. Rofecoxib (Vioxx) was removed in 2004 and valdecoxib (Bextra) in 2005 over concerns they raised the risk of cardiovascular events, such as heart attack and stroke, to unacceptable levels. (All NSAIDs increase the risk of cardiovascular side effects; risks rise with the dose and length of time used.)

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Akylosing Spodylitis Treatment

Drug Combination May Slow Ankylosing Spondylitis in Some Cases

For people with ankylosing spondylitis (AS) – a type of inflammatory arthritis that primarily affects the pelvis and spine – a pair of recent studies is shedding light on the possible benefits of a combination treatment with a nonsteroidal anti-inflammatory drug (NSAID) and a tumor necrosis factor (TNF) inhibitor (a type of biologic drug).

In AS, chronic inflammation in the sacroiliac joints (in the pelvis) and in the joints and ligaments along the spine creates pain and stiffness. During the early stages of the disease, joint damage may not be apparent in X-rays. (In these cases, the condition is called nonradiographic axial spondyloarthritis (nr-axSpA). As the disease progresses – and not all cases progress from nr-axSpA to AS – more joint damage occurs as the body grows new bone in an attempt to heal itself, which results in vertebrae fusing together. This reduces mobility and flexibility, and can lead to a hunched posture.
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