What is Vioxx?
Vioxx (rofecoxib) is a prescription COX-2 inhibitor nonsteroidal anti-inflammatory drug (NSAID). Vioxx works 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. Vioxx was used to treat arthritis, acute pain in adults, and painful menstrual cycles. Vioxx was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. Vioxx was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. It comes as a tablet and a liquid that is usually taken once a day orally with or without food.
Other Vioxx FAQs
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Q:
What is the COX enzyme?
A: 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 … More -
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Why has Vioxx been withdrawn from the market?
A: New research shows that a major Vioxx side effect is a greatly increased risk of cardiovascular (CV) events such as heart attack or stroke if used long-term. More -
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Were there any warning flags that led to Merck's recall of Vioxx?
A: Ever since the FDA sent a warning letter to Merck in 1999 calling Merck's promotional materials "false and misleading," and when the FDA directed Merck … More -
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What evidence supports the withdrawal?
A: Merck's decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. In the … More -
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Did the Food and Drug Administration (FDA) require this action?
A: No. Merck made this decision independent of input from the FDA. The FDA agrees with the company that there appears to be significant safety concerns for patients, … More -
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What action did the FDA take?
A: The FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck voluntarily withdrawing Vioxx from the market due to safety … More -
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Why wasn't the APPROVe trial stopped earlier?
A: The APPROVe trial began enrollment in 2000 and was being monitored by an independent data safety monitoring board (DSMB). It was not stopped earlier because the … More -
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What did the FDA know about the risk of heart attack and stroke when it approved Vioxx?
A: The FDA originally approved Vioxx in May 1999. The original safety data included approximately 5,000 patients taking Vioxx and did not show an increased risk of heart … More -
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What are NSAIDs?
A: 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 … More -
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Does the withdrawal of Vioxx from the market suggest that other drugs in the same class are dangerous?
A: The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class. Chronic use of NSAIDs has risks which … More
