• Home
• Defective Drug Index
• About A Drug Recall
• Contact A Defective Drug Lawyer

We Can Help.

Vioxx® Withdrawal

The voluntary Vioxx® withdrawal occurred on September 30, 2004. Merck decided that a Vioxx® withdrawal was the appropriate action to take to protect consumers from the potentially fatal side effects that could occur because of Vioxx® use. The Vioxx® withdrawal was the ultimate outcome of clinical findings indicating that patients taking Vioxx® for eighteen months were two times more likely to suffer from heart attack or stroke than patients taking a placebo. The Vioxx® withdrawal has subsequently provoked widespread concern about the cardiovascular safety of all COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs).

Prior to the Vioxx® withdrawal, this prescription medication had been prescribed to millions of people worldwide for the treatment of osteoarthritis, rheumatoid arthritis, chronic pain conditions, migraines, and primary dysmenorrhea. Vioxx® was approved in 1999, around the same time that other drugs of its class were gaining FDA approval. COX-2 selective NSAIDs were originally designed to provide pain relief without the harmful gastrointestinal side effects associated with original NSAIDs, such as ibuprofen and naproxen.

Clinical trial evidence from a study called VIGOR, released in 2000, compared the benefits and gastrointestinal risks of Vioxx® and naproxen. This research suggested that, though not any more effective at relieving pain than original NSAIDs, COX-2 selective pain relievers did prove to have a relatively lower risk of gastrointestinal complications. The VIGOR study also revealed that cardiovascular risks may be greater for patients taking Vioxx®, compared to those taking naproxen. These cardiovascular risks are what ultimately led to the Vioxx® withdrawal.

An FDA study of Vioxx® patients was also conducted prior to the Vioxx® withdrawal. This study involved the investigation of 1.4 million HMO patient's medical records. Upon examination, researchers found that patient's taking Vioxx® had suffered heart attack or stroke with greater frequency than patients who had been taking Vioxx® alternatives, such as Celebrex, and original NSAIDs. The APPROVe study came in on the coattails of this federal study. This study was designed to test the effects of Vioxx® on colon polyps. After eighteen months of research, the APPROVe study was stopped short because of serious cardiovascular risks in Vioxx® patients. This study prompted the Vioxx® withdrawal.

Since the Vioxx® withdrawal, numerous lawsuits have been filed against Merck, charging the pharmaceutical company with failing to adequately warn patients of the potentially serious side effects that could result from Vioxx® use. In late October 2004, it was estimated that 300 lawsuits were filed in the first fifteen days after the Vioxx® withdrawal. Vioxx® lawsuits are available to patients who have taken Vioxx® and/or have suffered injury as a result. The Vioxx® withdrawal has also prompted significant concern about the long-term cardiovascular safety of all non-steroidal anti-inflammatory drugs.

For more information on Vioxx® withdrawal and your legal rights, please contact us.

More Vioxx® Resources

MedLine Plus Drug Information - Guide to prescription and over-the-counter medications provided by the United States Pharmacopeia.

Vioxx.com - Official Vioxx Roxecofib site from Merck.

Vioxx Drug Warnings - Vioxx side effects information including lawsuit information and vioxx warnings.