What did the FDA know about the risk of heart attack and stroke when it approved Vioxx?
The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee, and the new safety information from this study was added to the Vioxx labeling in April 2002. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke associated with the long-term use of Vioxx.
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Additional Vioxx Articles
- What is Vioxx?
- What is the COX enzyme?
- Why has Vioxx been withdrawn from the market?
- Were there any warning flags that led to Merck's recall of Vioxx?
- What evidence supports the withdrawal?
- Did the Food and Drug Administration (FDA) require this action?
- What action did the FDA take?
- Why wasn't the APPROVe trial stopped earlier?
- What are NSAIDs?
- Does the withdrawal of Vioxx from the market suggest that other drugs in the same class are dangerous?
- Was there a request for a Vioxx recall by the FDA?
- Can my pharmacist continue to fill my prescription for Vioxx?
- What other drugs are similar to Vioxx?
- I had a prescription for Vioxx, and now that Vioxx is off the market, what questions should I ask my doctor in choosing a different COX-2 inhibitor?
- How can I report a serious Vioxx side effect to the FDA?
- Where can I get more information on Vioxx?