Vioxx Recall and Vioxx Side Effects
All About Vioxx and the Vioxx Global Recall
Vioxx Consumer Guide provides information about the Vioxx recall and the significant heart attack and other cardiovascular side effects of Vioxx. The Vioxx recall was a landmark event amidst many safety warnings during 2004 and 2005 about Vioxx side effects and the side effects of other COX-2 inhibitor drugs.
Rofecoxib, commercially known as Vioxx, is a pain reliever developed and produced by the pharmaceutical giant Merck and Co.
On September 30, 2004, Merck voluntarily withdrew Vioxx from the market after an internal study was stopped due to an increased risk of severe cardiovascular side effects among those taking Vioxx.
Vioxx was approved by the Food and Drug Administration (FDA) in 1999 as a treatment for osteoarthritis, severe back or joint pain in adults and for moderate to severe menstrual pain.
Vioxx was viewed as a breakthrough in pain relieving technology, as it was found to reduce or even eliminate intestinal irritation, stomach ulcers and other gastrointestinal side effects associated with traditional, "Aspirin type" painkillers.
Heavily marketed to consumers, Vioxx was also promoted by Merck sales representatives to physicians as a pain relieving medicine of choice. As a result, Vioxx was sold to more than 92 million patients in the U.S. since its approval in 1999. The majority of Vioxx users ended up taking the drug over extended periods of time due to the chronic nature of their ailments, such as arthritis, osteoarthritis and rheumatoid arthritis.
It is estimated that at the time of the recall, as many as 2 million patients were taking Vioxx worldwide. Recent reports indicate that the cardiovascular side effects of Vioxx could have caused as many as 100,000 hospitalizations, 27,785 heart attacks and strokes, and possibly as many as 10,000 to 15,000 deaths in the U.S.
There is evidence that Merck knew about the cardiovascular side effects of Vioxx as early as 2000, four years before the manufacturer pulled the popular pain reliever from the market.
Vioxx Is a COX-2 Inhibitor
Vioxx belongs to a class of non-steroidal anti-inflammatory medications (NSAIDs) called COX-2 inhibitors. These medications work by blocking the production of cyclooxygenase-2 (COX-2), an enzyme responsible for pain, inflammation and swelling in the human body.
COX-2 inhibitors work similarly to traditional pain relievers such as aspirin, ibuprofen (Motrin, Advil) or naproxen (Aleve). However, traditional pain relievers may cause upset stomach and ulcers when taken over extended periods of time.
Discovered in 1986, COX-2 inhibitor drugs, such as Vioxx, were thought to represent a breakthrough in pain-relieving technology. The medications alleviated the pain and swelling associated with inflammation while reducing the stomach and intestinal side effects associated with aspirin, ibuprofen and other types of traditional pain relievers.
However, recent studies indicate that while blocking the harmful COX-2 effects related to pain and inflammation, Vioxx also blocks the beneficial balancing effect that COX-2 enzymes have on the heart and cardiovascular system. The balance disturbed by Vioxx may be the cause of increased rates of heart attack and stroke in patients taking the pain reliever.
COX enzymes and COX-2 inhibitors are explained in detail on other pages of our website.
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