Merck Vioxx News and Press Releases

Doctors issue warning on Bextra, too

Big News Network.com - 23rd December, 2004 Three U.S. researchers say doctors should stop prescribing Bextra, a sister drug to Celebrex, which Friday was linked to increased cardiovascular risk.

The New England Journal of Medicine Friday released a letter to the editor, which had been scheduled to be published Dec. 23, in which Vanderbilt University researchers Wayne A. Ray, Dr. Marie R. Griffin, and C. Michael Stein wrote: Rofecoxib (Vioxx) was recently withdrawn from the market because of an increased risk of myocardial infarction and stroke. There is a similar public health concern about another coxib, valdecoxib (Bextra), which is used by 7 million patients worldwide. To protect the safety of the public, we write to recommend that clinicians stop prescribing valdecoxib except in extraordinary circumstances.

Vioxx, Celebrex and Bextra all are COX-2 inhibitors that relieve pain and reduce inflammation. Results of a cancer trial using Celebrex, released Friday by drugmaker Pfizer, showed a 2.5 fold increase in the risk of serious cardiovascular events among participants. A second similar study, however, did not show a risk.

We believe this restriction should remain in effect until there are better safety data for valdecoxib, the Vanderbilt researchers wrote about Bextra.

Painkiller Sales Decline

Associated Press - Feb. 14, 2005

WHAT DECREASED: Sales of prescription arthritis drugs dropped from 4.5 million in September to 2.7 million in December, after Vioxx was pulled from the market and studies raised safety concerns about other widely used pain medicines.

WHAT INCREASED: Sales of nonprescription pain pills jumped about 12 percent from July-September to October-December.

DOING WITHOUT: Doctors and other pain experts believe many confused patients simply stopped taking pain medication.

Ipsos Ideas: Vioxx Recall Hurt Americans' Confidence in FDA, Not Prescription Drugs

Consumers understand trade-offs between drug benefit and risks, according
to Ipsos survey

NEW YORK, March 9 /PRNewswire/ - Consumer response to concerns about COX-2 inhibitors Celebrex, Vioxx, and Bextra was emblematic of how informed health consumers are changing pharmaceutical manufacturers' susceptibility to shifts in public opinion, consumer confidence, and corporate credibility. Despite the hype, Americans are more confident in safety of prescription drugs than they are in the Federal Drug Administration's ability to ensure safety
with use.

The findings of an Associated Press and Ipsos Public Affairs poll suggest that consumers acknowledge the inherent risks in pharmaceutical drugs, but want the risks and benefits to be clearly communicated and effectively
scrutinized by the agency approving the drugs that come to market, according to Fariba Zamaniyan, Vice President of Marketing and Business development for the Ipsos Health practice and a specialist in prescription drug purchase
trends.

"Americans expect the FDA to do a better job of scrutinizing drugs before they come to market, and of communicating the risks," said Zamaniyan, "but, ultimately, pharmaceutical manufacturers will have to respond quickly and address the public's safety concerns and information demands, or risk losing consumer confidence."

In her essay "Dr. Jekyll and Mr. Hyde: Pharmaceutical Companies Contend with Drug Benefit and Risk Communications" Zamaniyan examines the new predicament for pharmaceutical manufacturers. "With greater consumer brand awareness comes increased sensitivity to shifts in public opinion, consumer confidence, and corporate credibility."

The essay appears in the latest issue of Ipsos Ideas, the newsletter published by the Ipsos Group, the fastest growing market research company in the U.S. Ipsos Ideas delivers the insights and ideas that Ipsos has gleaned
from each of their research specialty practices: advertising, customer loyalty, marketing, public affairs, and forecasting, modeling, and consulting.

To peruse the full release, please go to:
http://www.ipsos-na.com/news/pressrelease.cfm?id=2591

For more information, please contact:
Fariba Zamaniyan
Vice President
Ipsos Health
646.313.7657
fariba.zamaniyan@ipsos-na.com

January 17, 2005
Volume 83, Number 3
p. 15

SCIENCE AND TECHNOLOGY

Investigating Vioxx Toxicity
Air oxidation of arthritis drug's anion forms a potentially toxic product

A. MAUREEN ROUHI

Oxidation to a maleic anhydride derivative may be a factor in the long-term toxicity of rofecoxib (Vioxx), a new report suggests. This previously unknown reactivity is not shared by other cyclooxygenase-2 (COX-2) inhibitors, such as celecoxib (Celebrex), valdecoxib (Bextra), and lumiracoxib (Prexige). The hypothesis, if proven true, runs counter to the assumption that other COX-2 inhibitors pose the same risk to humans as Vioxx.

Vioxx was withdrawn from the market last September by its manufacturer, Merck, after a clinical trial indicated that it poses an increased risk of cardiovascular events.

Vioxx is a weak acid, and the anion formed when it releases its acidic proton is highly reactive toward atmospheric oxygen, according to laboratory studies by Harvard University chemists Leleti Rajender Reddy and E. J. Corey. The products are principally a maleic anhydride and lesser amounts of a -hydroxybutenolide [Tetrahedron Lett., published online Dec. 25, 2004, http://dx.doi.org/10.1016/j.tetlet.2004.12.055].

According to the authors, the maleic anhydride has not been reported as a Vioxx metabolite. They suggest that some of it may survive long enough in vivo to react with the nucleophilic groups of biomolecules and tissues. “The consequences of this may be a low-level chronic toxicity that is cumulative and possibly dangerous over periods of many months. It is perhaps not irrelevant that the cardiotoxicity of Vioxx was not apparent from short-term (one year or less) studies,” they write.

Merck’s withdrawal of Vioxx has cast doubts on other COX-2 inhibitors in the market or in development. However, as the authors point out, the formation of an oxygen-reactive anion is unique to Vioxx. The difference in the structures of Vioxx and other COX-2 inhibitors has been “overlooked in the medical and general literature,” they write.

In a footnote, the authors say that they have disclosed their findings to the Food & Drug Administration. Corey is a scientific adviser to Pfizer, the maker of Celebrex and Bextra.

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