Definitions of Terms Used on the Vioxx Advisor
Anaphylaxis: A severe allergic reaction that can cause hives and swelling of the throat, neck, and other exposed areas. In severe cases, anaphylaxis can cause the body to go into anaphylactic shock, which involves a sudden drop in blood pressure and a swelling of the airways. It can be fatal if not treated within minutes; emergency measures may include CPR and adrenaline injections.
Autoimmune Disease: Any disease of the immune system in which the immune system attacks tissues and/or materials that are not normally harmful to or are a part of the body. The immune system normally protects the body from infection and helps to promote healing, but in patients with autoimmune disease, the immune system becomes overactive and attacks non-infected materials, or even entire areas of the body. For example, in the case of Rheumatoid Arthritis, the immune system attacks the lining of the joints, causing pain and inflammation.
Ankylosing Spondylitis (AS): A degenerative form of arthritis primarily affecting the spine. AS is an autoimmune disease (see above definition) and is believed to be caused by a genetic predisposition.
Black Box Warning: A printed warning included on the packaging of a drug, which is enclosed in a black box to distinguish it from other packaging information and to draw the user’s attention. In the case of Vioxx, in 2002, a black box warning was added describing the risk of cardiovascular complications associated with the drug. Celebrex, which is still on the market, carries essentially the same black box warning concerning cardiovascular complications.
Chronic: Term describing any condition that recurs continually or repeatedly, or that worsens over time. This term is used in contrast to acute, which refers to short-lived or single-instance conditions.
DMARD: Disease-Modifying Anti-Rheumatic Drug. DMARDs are used to slow the progression of diseases like Rheumatoid Arthritis, which are directly caused by a malfunction of the immune system. These drugs attempt to prevent the immune system response from worsening the disease, and are often used in conjunction with pain killers, which merely treat the disease symptoms.
Inactive Ingredients: All of the ingredients of a medication besides the “active” ingredient. In the case of Vioxx, “rofecoxib” is the active ingredient. Inactive ingredients may include things like coloring, flavoring, and texture stabilizers. These ingredients may vary between different manufacturers of the same drug; however, the active ingredient must be the same.
Juvenile Rheumatoid Arthritis (JRA): Now called Juvenile Idiopathic Arthritis (JIA), JRA formerly referred to any form of inflammation of joint tissue that appears in childhood, and may be chronic or acute.
Lipid: Any fat-soluble molecule found in the body. Lipids come in various forms and have multiple physical functions, including energy storage, assisting in neural (nerve-related) communication within the body, and even making up part of the structure of cell membranes.
Naproxen: A non-selective NSAID that has been used in various clinical trials as a base of comparison to test both the safety and efficacy of selective COX-2 inhibitors, including Vioxx.
Osteoarthritis: A type of arthritis in which overuse or normal wear-and-tear of the joints causes the cartilage, which normally cushions the movement of the joints, to become damaged and worn. The body responds with inflammation, which in turn causes pain. Osteoarthritis is considered a degenerative condition because it usually worsens with the passage of time.
Prostanoids: A subclass of fatty acid molecules, found in every body system, which interact with the enzyme cyclooxygenase (COX) to cause inflammation of tissues. Prostanoids come in three forms: prostaglandins, which are associated with pain and inflammation; thromboxanes, which assist in forming necessary blood clots; and prostacyclins, which are involved with platelet production and also assist the blood in clotting.
Rheumatoid Arthritis (RA): A type of arthritis in which the immune system attacks the cartilage that cushions the joints from the friction of movement. In some cases, the immune system also attacks other organs. The symptoms of RA can be treated with NSAIDs, but the disease itself is an autoimmune disorder and must be treated with a class of drugs called DMARDs.