Super Aspirins of the Late 1990s
In the late 1990s, pharmaceutical companies released a new class of drugs called “super aspirins.” These drugs — Bextra, Vioxx, and Celebrex — were touted as the miracle treatment for arthritis, a disease affecting an estimated 28 million Americans.
The idea behind the super aspirins was that they would act as strong pain relievers by reducing the inflammation associated with arthritis. The major promised benefit of these drugs was that they would treat pain without the risk of peptic ulcers associated with traditional NSAIDs like aspirin.
In addition to the conditions detailed below, Vioxx was prescribed for acute pain conditions in adults. In March of 2004, it gained FDA approval for the treatment of migraine headaches. Although the use of Vioxx for one year or longer was later proven to carry significant cardiovascular risk, these short-term uses never demonstrated the same level of cardiovascular risk.
Vioxx and Arthritis
Arthritis is a chronic disease commonly associated with old age or overuse of joints, and in some cases an immune deficiency. In an arthritic patient, the cartilage protecting a joint becomes worn, and the body responds with inflammation, which in turn causes pain. Osteoarthritis is a type of arthritis in which overuse or repetitive movements cause the cartilage to become worn. Rheumatoid arthritis, on the other hand, is caused by the immune system attacking the cartilage protecting a joint. Ankylosing Spondylitis is another form of arthritis that affects the spine. Vioxx was prescribed for all of these types of arthritis.
COX-2 inhibitors, like Vioxx, treat pain by targeting a chemical in the body that causes inflammation. COX-2 inhibitors are used in low doses to treat pain, and in higher doses to treat inflammation. Unfortunately, high doses of Vioxx were shown to cause a much higher incidence of cardiovascular complications, for which the primary age group suffering from arthritis was already at increased risk.
In September of 2004, only weeks before Vioxx was withdrawn from the worldwide market, it was approved by the FDA for the treatment of Juvenile Rheumatoid Arthritis (JRA).
Vioxx and Dysmenorrhea (Painful Menstruation)
Vioxx was approved for use “as needed” in patients with dysmenorrhea. Dysmenorrhea is a condition characterized by severe pain in the uterus during menstruation, sometimes accompanied by heavy bleeding. Dysmenorrhea is associated with the release of prostaglandins in the uterus, which is why the condition responds to NSAIDs. Dysmenorrhea usually affects women under the age of 30, and is often accompanied by other factors such as early menarche (first menstruation), PMS, and other menstrual problems.
Vioxx and Colorectal Adenomatous Polyps
Clinical trials measured the effectiveness of COX-2 inhibitors in preventing the regrowth of colorectal adenomatous polyps, benign polyps found in the colon and rectum that often lead to cancer of those organs. In the Adenomatous Polyp Prevention on Vioxx (APPROVe) study, Vioxx was tested on more than 1,000 patients with a history of colorectal adenomas. Although Vioxx was found to be effective in treating the polyps, the study was terminated early because of a high incidence of heart attacks in the Vioxx study group.
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