What did the FDA know about the risk of heart attack and stroke when it approved Vioxx?
By: LawInfo
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 attack or stroke. A later study, VIGOR (VIOXX Gastrointestinal Outcomes Research), was primarily designed to look at the effects of Vioxx on gastrointestinal (GI) side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000. The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking the over-the-counter drug naproxen. However, the study also showed that patients taking Vioxx were four times more likely to have a heart attack, stroke or other serious cardiovascular event.
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.
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 FAQs
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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Why has Vioxx been withdrawn from the market?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 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 -
Q:
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
