Untitled Document

Vioxx®, or rofecoxib, is a non-steroidal anti-inflammatory drug (NSAID) approved by the Food and Drug Administration (FDA) in 1999 and prescribed to help ease acute pains associated with osteoarthritis, rheumatoid arthritis, menstrual cramps, migraines and other painful conditions. Merck, its manufacturer, claimed the drug's benefit over existing treatments was its ability to reduce pain without any gastrointestinal (GI) side effects, which are typical in other NSAIDs such as aspirin or ibuprofen.

But now, the drug has been linked to several cardiovascular risks. And on September 30, 2004, Merck announced the immediate voluntary worldwide withdrawal of Vioxx, a decision based on new data from a three-year Vioxx trial.

What are NSAIDs and what are their side effects?
NSAIDs, or Non-Steroidal Anti-Inflammatory Drugs, are very common to household medicine cabinets. Over-the-counter and prescription drugs like aspirin, ibuprofen, and naproxen are all NSAIDs. This class of drug works by blocking the COX-2 enzyme in the body, which reduces swelling; however, they also block the COX-1, which involves digestion in the GI tract. This often causes serious GI side effects, including ulcers, burns and bleeding in the stomach lining.

Vioxx, and the Pfizer drug Celebrex®, belong to a special group of NSAIDs called COX-2 selective inhibitors. These drugs block the inflammation-causing COX-2 enzyme without blocking the COX-1, an action that, theoretically, should preserve all of the NSAID benefits while eliminating the gastrointestinal side effects.

What dangers are associated with Vioxx?
Concerns about Vioxx began to emerge with the release of data from the Merck-initiated Vioxx Gastrointestinal Outcomes Research (VIGOR) study in November 2000. The trial was designed to chart the difference in gastrointestinal effects between Vioxx and naproxen. However, the results also revealed a possible trend that suggested Vioxx—at the 50 mg. dose—may be responsible for an increased risk of adverse cardiovascular events, including:

In August 2004, at the ISPE annual conference, an interdisciplinary forum to discuss various pharmaceutical issues, a study was presented, the results of which introduced distressing new figures about the relative safety of high doses of Vioxx. The study, funded by an FDA contract with HMO giant Kaiser Permanente, found that, “higher-dose [Vioxx] (>25 mg/d) conferred a 3.15-fold increased risk of AMI and SCD compared with remote use of any NSAID.” It further concluded that, even at a lower dose, “[Vioxx] < 25 mg/d conferred an increased risk of AMI and SCD compared with [Celebrex].” 3

And on September 30, 2004, Merck announced the voluntary withdrawal of the drug, a decision based on early data from the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial. The trial, which is being stopped, was designed to evaluate the long-term effectiveness of Vioxx on preventing recurring colorectal polyps. However, the study also suggested an unforeseen result: “ … an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo.” 6

What actions are being taken to protect consumers?
Since the possible adverse cardiovascular effects of COX-2 inhibitors revealed in the VIGOR study were published, researchers and experts have been pursuing the answer to the question of Vioxx's safety. The FDA reviewed the issue in February 2001, and many of the present experts and committee members voiced their questions and concerns.

On September 17, 2001, the FDA sent Merck a warning letter stating their Vioxx campaign, “minimized the potentially serious cardiovascular findings that were observed in the [VIGOR] study, and thus, misrepresented the safety profile for Vioxx.” The FDA also reprimanded Merck for false or misleading statements made during promotional conferences, press releases and sales pitches, which misrepresented the safety of Vioxx and promoted it for unapproved uses; the FDA instructed Merck to cease promotional activities until the problem was corrected.

By April 11, 2002, the FDA required Merck to place cardiovascular warnings on Vioxx labels. In addition, they were required to include a new label warning that Vioxx at 50 mg. or more per day is not recommended for chronic use.

In September 2004, Merck made the decision to withdraw Vioxx from the market, citing the preliminary results of the APPROVe trial; executives decided that the action, “best serves the interests of patients.” 6

What should I do if I took Vioxx?
Merck executives advise patients taking Vioxx to consult with their physician “to discuss discontinuing use of Vioxx” and to discuss the possibility of alternative treatments. 6 And if you or someone you know has suffered a heart attack or other cardiovascular problems after taking Vioxx, contact our law firm; we would like to help.

Consult with your physician if you have questions concerning this medication. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Vioxx® is a registered trademark of Merck & Co., Inc. and is used here only for the purpose of identifying the product in question.

Celebrex® is a registered trademark of Pfizer Inc. and is used here only for the purpose of identifiying the product in question.

This law firm is not affiliated with, sponsored by or associated with Merck & Co., Inc., Pfizer Inc., the FDA, JAMA, IPSE, The Wall Street Journal, Reuters, or MSNBC.com.