Vioxx FAQs

• Q: What is Vioxx?
  A: 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 … More
• 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
• Q: Why has Vioxx been withdrawn from the market?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
• Q: 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
• Q: 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
• Q: 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
• Q: 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
• Q: 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
• Q: 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
• Q: 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