Consult with your physician if you have questions concerning this medication.
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.
are NSAIDs and what are their side effects?
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.
dangers are associated with Vioxx?
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
actions are being taken to protect consumers?
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
should I do if I took Vioxx?
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.
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