Celebrex Frequently Asked Questions
- What is Celebrex?
- What is the COX enzyme?
- What is the problem with Celebrex?
- What are the Celebrex side effects?
- What are NSAIDs?
- What is edema?
- What is pitting edema?
- What is non-pitting edema?
Similar to Vioxx, Celebrex is a COX-2 inhibitor belonging to the drug class nonsteroidal anti-inflammatory drug (NSAID). Like Vioxx, Celebrex was approved by the Food and Drug Administration (FDA) for the relief of pain and inflammation of osteoarthritis (OA) and rheumatoid arthritis (RA), as well as management of acute pain in adults and primary dysmenorrhea (painful menstrual cramping). And, like Vioxx, Celebrex provides pain relief by inhibiting the COX-2 form of the COX enzyme to block production of prostaglandins. Prostaglandins are hormone-like substances that contribute to the symptoms of pain, fever and inflammation.
The cyclooxygenase (COX) enzyme has two forms: COX-1 and COX-2. COX-1 is found in a lot of cells all the time, notably the lining of the stomach where it regulates acid production. COX-2 is not present in most cells normally, only appearing when things are going wrong. As a result, COX-2 was thought to be responsible for the bad effects of the COX enzyme-pain and inflammation.
Celebrex was developed based on this belief that COX-2 was responsible for the bad effects of the COX enzyme and to reduce or even eliminate the gastrointestinal risks involved with the non-selective (traditional) NSAIDs like Aspirin ( acetylsalicylic acid, ASA), Ibuprofen, Nabumetone and Naproxen, that inhibit both COX-1 and COX-2 enzymes. However, COX-2 serves other purposes besides its role in inflammation. Among the purposes the COX-2 enzyme serves is that it plays a major role in controlling the cardiovascular system-stopping platelets from forming blood clots (thrombi - plural form of thrombus) in the heart, and preventing damage to vessels. It also serves other functions that are beyond the scope of this FAQ to explain.
What is the problem with Celebrex?
It has been recently found that Celebrex, like the other COX-2 inhibitors Vioxx and Bextra increases the risk of heart attacks by 2.5 times, as well as strokes and blood clots. Among the researchers that have found these issues with Celebrex are
- Dr. Garret FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania and his team of researchers who have indicated that the COX-2 inhibitor painkillers suspected of causing fatal heart disease may act by starting the process of hardening the arteries;
- The National Cancer Institute, which was conducting a long-term cancer study for Pfizer, and prematurely stopped it after finding that patients taking 400mg to 800mg of Celebrex daily had a 2.5 times greater risk of major heart problems than those who were taking placebos (look-alike pills with no active ingredients); and
- A study conducted by the Cleveland Clinic that appeared in the Journal of the American Medical Association, which indicated that the annual rates of heart attack in both the Celebrex (celecoxib) and Vioxx (rofecoxib) studies were increased compared to a review of studies containing a total of more than 48,000 patients.
As a result of these findings, Pfizer and the Food and Drug Administration (FDA) are being pressured by consumer groups to recall the drug. Pfizer does not plan on recalling the drug and the FDA could not be reached for comment.
What are the Celebrex side effects?
The ones causing the biggest uproar are the greatly increased risk of heart attack, and the increased risk of stroke and blood clots because those indicate overall safety concern with an entire class of drugs-COX 2 inhibitors. However, there are other dangerous side effects and health conditions that greatly increase the risk of these side effects. For more information on side effects, please visit the Celebrex Side Effects page.
NSAIDs are a large group of drugs that have pain-relieving (analgesic) and fever reducing (antipyretic) effects, as well as the effect of reducing inflammation when used over time. The anti-inflammatory effects may take anywhere from a few days to three weeks to take effect. Non-selective (traditional) NSAIDs like Ibuprofen, aspirin, Nabumetone and Naproxen work by inhibiting both the COX-1 and COX-2 enzymes to stop the production of prostaglandins, while COX-2 inhibitors only block the COX-2 enzyme. Common uses for NSAIDs are:
- Treatment of pain and inflammation associated with arthritis (inflammation and resulting pain of one or more joints, a common characteristic of over 200 rheumatic diseases with Osteoarthritis (OA) and Rheumatoid Arthritis (RA) being the most common forms).
- Back pain and sciatica (pain down into the leg, which travels below the knee, and may involve the foot - may occur alone or accompanied by low back pain).
- Sprains, strains and rheumatism (a chronic autoimmune disease with inflammation of the joints and marked deformities).
- Dental Pain
- Post-operative pain
- Menstrual cramps (primary dysmenorrhoea - mild, and menorrhagia - heavy).
- Pain from kidney stones (renal colic).
- Reduction of fevers
- Migraines (recurrent severe headaches generally accompanied by an aura (classic migraine), nausea, vomiting, and dizziness).
- "Other painful conditions, particularly those with symptoms of inflammation.
NSAIDs come in different formulas and in over-the-counter (OTC) and prescription strengths. Some may work better for you than others. Your physician can help you find the dose and medication that works best for you. Tell your physician if you are pregnant, have high blood pressure, asthma, or a history of kidney or liver disease, or have had ulcers in the past. People over age 65 must be especially careful when taking NSAIDs. Also tell your doctor about other medications you are taking. NSAIDs may intensify or counteract the effects of some medications. Both the risk and the severity of side effects increase the longer you take NSAIDs.
Edema is an observable swelling in certain parts of the body. Edema most commonly occurs in the feet and legs (peripheral edema). The swelling is the result of the accumulation of excess fluid under the skin in the spaces within the tissues that are outside of the blood vessels (interstitial spaces or compartments). Most of the body's fluids that are found outside of the cells are normally stored in two spaces; the blood vessels (where the fluids are called the blood volume) and the interstitial spaces (where the fluids are called the interstitial fluid).
If you depress the skin of a swollen area (e.g., leg) with a finger and the pressing causes an indentation in the skin that persists for some time after the release of the pressure, it is pitting edema. Any form of pressure, such as from the elastic part of socks, can induce the pitting of this edema. Pitting edema is caused by either systemic diseases, that is, diseases that affect the various organ systems of the body, or by local conditions involving just the affected extremities.
The most common systemic diseases that are associated with pitting edema involve the heart, liver, and kidneys. In these diseases, edema occurs primarily because of the body's retention of too much salt (the chemical compound sodium chloride). The excess salt holds excess water in the interstitial tissue spaces (edema). Idiopathic (of unknown cause) edema, also sometimes called cyclical edema, occurs most often in women and just prior to each menstrual period. The most common local conditions that cause edema are varicose veins and thrombophlebitis (a blood clot with inflammation of the veins) of the deep veins of the legs. These conditions can cause inadequate pumping of the blood by the veins (venous insufficiency). The resulting increased back-pressure in the veins forces fluid to leak into the interstitial tissue spaces (edema).
Non-pitting edema is where there is not a persistent indentation to the skin. It normally affects the arms and legs. Non-pitting edema can occur in certain disorders of the lymphatic system such as primary (congenital) lymphedema, which is either a congenital absence of, or abnormalities in, lymphatic tissue, or secondary lymphedema, an obstruction or a disturbance of the lymphatic circulation that may occur in malignancies, infection, trauma, excision, or post-radiation fibrosis. Another cause of non-pitting edema of the legs is called pretibial myxedema, which is a swelling over the shins that occurs in some patients with hypothyroidism (underactive thyroid gland).