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What Evidence Supports The Withdrawal?

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 APPROVe trial, a 156week (threeyear) trial, Vioxx was compared with placebo (sugar pill). The purpose of the trial was to see if the 25 mg dose of Vioxx was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk of serious cardiovascular events, such as heart attack and stroke, after 18 months of continuous treatment with Vioxx.

Other Vioxx FAQs

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 concerns.
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 painrelieving (analgesic) and fever reducing (antipyretic) effects, as well as the effect of reducing inflammation … More
Q: Can My Pharmacist Continue To Fill My Prescription For Vioxx?
A: No. Merck is initiating a market withdrawal in the U.S. to the pharmacy level. This means Vioxx will no longer be available at pharmacies. I had a prescription for … 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
Q: Were There Any Warning Flags That Led To Merck's Recall Of Vioxx?
A: When the FDA sent a warning letter to Merck in 1999 calling Merck's promotional materials "false and misleading," and when the FDA directed Merck to send a letter to … More
Q: What Is Vioxx?
A: Vioxx (rofecoxib) is a prescription COX2 inhibitor nonsteroidal antiinflammatory drug (NSAID). Vioxx works by inhibiting the COX2 form of the COX … 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Q: Why Has Vioxx Been Withdrawn From The Market?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 longterm. More
Q: Did The Food And Drug Administration (Fda) Require The Removal Of Vioxx?
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 Other Drugs Are Similar To Vioxx?
A: Vioxx is related to the nonselective (traditional) NSAIDs aspirin, Ibuprofen, Nabumetone, Naproxen, Ketoprofen and other traditional NSAIDs. Celebrex (celecoxib) … More

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