Friday, September 30, 2005
Bextra Data Suggests All Cox-2 Drugs Pose Heart Risks - vioxx
Bextra Data Suggests All Cox-2 Drugs Pose Heart Risks
Pfizer's McKinnell May Report Stagnant Sales Growth (Update1)
Atlanta Journal Constitution (subscription) - Atlanta,GA,USA
... The other two drugs in this class are Merck & Co.'s Vioxx, which was pulled from the US market in late September after data linked its long-term use to ...
Bloomberg - USA
... pulled its painkiller Vioxx from the market Sept. 30 because of heart risks. McKinnell repeatedly vouched for Celebrex's safety ...Patients should demand full lifetime refunds on Vioxx, COX-2 ...
News Target - Taichung,Taiwan
... bought it? Do you see people getting their money back for all the Vioxx they purchased over the last few years? Of course not. I ...
Dimethaid expects to resubmit drug to FDA
The Globe and Mail - Toronto,ON,Canada
... Inc.'s recall of the arthritis pain drug Vioxx from the market in September over concerns its use could raise the risks of heart attack. ...
Vioxx alternative lifts Abbott Labs' earnings 9 percent
Chicago Sun-Times - Chicago,IL,USA
... quarter profit rose 9 percent on surging sales of the painkiller Mobic, which arthritis patients are using as an alternative to Merck & Co.'s withdrawn Vioxx. ...Attorney General Darrell Mcgraw Announces Expansion Of Vioxx ...
All American Patriots (press release) - Taeby,NA,Sweden
... announced in December of 2004 that pharmaceutical giant Merck had agreed to significantly alter its consumer refund program for unused Vioxx, the popular ...
Painkiller Combo Cut Post-Surgery Morphine Need
Reuters - UK
... To determine if combination treatment with gabapentin (Neurontin) and rofecoxib (Vioxx) -- two analgesic agents with different modes of action -- improves ...
Hundreds of Lawyers Gather at LexisNexis-Sponsored Symposium On ...
PharmaLive.com (press release) - Newtown,PA,USA
To RSVP and obtain credentials for the Vioxx Litigation Conference, please contact Erin Bocherer at 614.825.1796 or erin.bocherer@fahlgren.com. ...
Pfizer Doesn't Give Much Fizz
Motley Fool - USA
... Despite the concerns over COX-2 inhibitors created by Merck's (NYSE: MRK) withdrawal of Vioxx, Celebrex, and Bextra, both reported higher sales. ...Drug companies face poor fourth quarter
Newark Star Ledger - Newark,NJ,USA
The Vioxx withdrawal, litigation and generic competition haunted the country's largest pharmaceutical companies in the fourth quarter and their earnings for ...
Thursday, September 29, 2005
FDA Selects Ingenix for Drug Safety Monitoring and Support
| FDA Selects Ingenix for Drug Safety Monitoring and Support BASKING RIDGE, N.J.--(BUSINESS WIRE)--Sept. 28, 2005--UnitedHealth Group (NYSE:UNH): -- New Technology to Help Accelerate Identification of Drug Safety Signals Ingenix, a wholly owned subsidiary of UnitedHealth Group (NYSE:UNH), has been selected by the United States Food and Drug Administration (FDA) to help improve the effectiveness and speed of safety evaluations for pharmaceutical agents. The Ingenix program is built around a team of leading epidemiologists, complex analytic tools, and the largest and most complete longitudinal patient database available today. It will work with the FDA to monitor the safety of new drugs as well as conduct ad hoc safety studies on established pharmaceutical agents. "We are pleased to provide our extensive data resources and analytic capabilities to help the FDA respond to the urgent need for improved drug safety," said Terri Madison, PhD, MPH, president of i3 Drug Safety which will lead the Ingenix program. "These proactive efforts should enhance the FDA's ability to identify and assess issues and potential risks related to pharmaceutical agents in a more timely fashion than ever before." About Ingenix A leading health information company, Ingenix provides products and services to a diverse customer base within the health care community. Organizations rely on its innovative technology to improve the delivery and operations of their business. More information about Ingenix and its products and services can be obtained at www.ingenix.com. About i3 i3, a global Ingenix company, provides integrated scientific strategies and solutions throughout pharmaceutical product lifecycle. It includes: i3 Research, a therapeutically specialized contract research organization; i3 Drug Safety, which is engaged in pharmacovigilance and epidemiology; i3 Statprobe, a technologically focused provider of comprehensive data services; i3 Pharma Resourcing, a world-class staffing partner; i3 Magnifi, which provides health economics and outcomes services; and i3 DLN, a provider of certified medical education. i3 helps companies gain sharper insights that lead to improved patient care. For more information, visit www.i3global.com. |  |
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Tuesday, September 27, 2005
Consumer group faults FDA oversight, cites 'worst pills'
Consumer group faults FDA oversight, cites 'worst pills'
AXcess News - Carson City,NV,USA
... The removal the arthritis medication Vioxx from the market late last year after its maker admitted increased risks of heart attacks is not enough to shield the ...Legislator joins Vioxx case
Monitor - McAllen,TX,USA
RIO GRANDE CITY -- The makers of Vioxx on Friday hired a second state legislator to defend the company against a Starr County family's lawsuit and filed a ...Dimethaid Q2 loss widens to $7.3M despite strong Pennsaid ...
Canada.com - Canada
... by $1.1 million, but the company said Friday it sees potential sales growth for its arthritis drug Pennsaid after the withdrawal of rival Vioxx on concern over ...
Ellen Goodman: We're skating on thin ice
Dallas Morning News (subscription) - Dallas,TX,USA
I kind of miss seeing Dorothy Hamill glide across the surface of those Vioxx commercials on her silver blades. The Gold Medal winner ...Painkiller Hearings Announced By FDA
Health Talk - Toronto,Ontario,Canada
Hearings looking into the benefits and risks of cox-2 inhibitors like Pfizer's Celebrex and Bextra and Merck's Vioxx will begin next month, the US Food and ...Experts Available to Discuss Risks Associated with Taking Aspirin
Business Wire (press release) - San Francisco,CA,USA
Some experts believe the increase is due to the new knowledge regarding the harmful side effects of pain relievers such as Vioxx and Celebrex. ...Assessing the risks
Kansas City Star (subscription) - Kansas City,MO,USA
... After warnings about the popular arthritis drugs Vioxx, Celebrex, Bextra and naproxen, the drug in Aleve, health authorities are reviewing dozens of studies of ...Federal tort liability reform is a prescription for disaster
The Register-Guard - Eugene,Oregon,USA
... The popular painkillers Vioxx and Celebrex are cases in point. ... Merck & Co. decided on its own to take Vioxx off the market last fall. Pfizer Inc. ...A double-edged scalpel: Studies make you crazy
San Jose Mercury News (subscription) - San Jose,CA,USA
By Ellen Goodman. I kind of miss seeing Dorothy Hamill glide across the surface of those Vioxx commercials on her silver blades. ...Dimethaid to resubmit arthritis drug to FDA by mid-2006; expects ...
Canada.com - Canada
... it expects the arthritis pain-treating lotion Pennsaid, its great hope to capitalize on an arthritis drug vacuum after the US withdrawal of Vioxx, will be ...Drug firms seek profit in giveaways
Boston Globe - Boston,MA,USA
... enticed consumers with free-trial offers and discounts on their Vioxx and Celebrex painkillers, helping to build them into billion-dollar blockbusters before ...THE FINANCIAL PAGE
New Yorker - New York,NY,USA
Ever since Merck announced, this past fall, that the pain reliever Vioxx could be linked to an increased risk of strokes or heart attacks, ads from lawyers ...
Sunday, September 25, 2005
Arthritis patients who took Vioxx seek other ways to lessen pain
Arthritis patients who took Vioxx seek other ways to lessen pain
AZ Central.com - AZ,USA
... ago. Not so good, but not so bad, either, as a new wonder drug, Vioxx, proved highly effective in helping Nichols control her pain. ...Most medicines carry risks
DetNews.com - Detroit,MI,USA
... health issues have been more confusing than the barrage of news reports over the past three months linking popular pain relievers -- Vioxx, Celebrex, Bextra ...To George W. Bush, donating money means passing the buck. By ...
The American Prospect - Boston,MA,USA
... The popular painkillers Vioxx and Celebrex are cases in point. ... Merck & Co. decided on its own to take Vioxx off the market last fall. Pfizer Inc. ...What is a safe drug?
Houston Chronicle - Houston,TX,USA
... Recent experience with Vioxx and Celebrex, however, suggests that patients, physicians and drug regulators are not being cautious enough. ...
Put safety before sales
Sarasota Herald-Tribune - Sarasota,FL,USA
... leading cardiologists, who recently warned about the dangers of allowing pharmaceutical companies to aggressively market drugs, such as Vioxx, directly to ...Locals suing maker of Vioxx
NapaNet Daily News - Napa,CA,USA
Four Napa County residents are joining a national flood of personal injury lawsuits against drug company Merck & Co., maker of the arthritis drug Vioxx. ...
Hundreds of Lawyers Gather at LexisNexis-Sponsored Symposium On ...
Business Wire (press release) - San Francisco,CA,USA
To RSVP and obtain credentials for the Vioxx Litigation Conference, please contact Erin Bocherer at 614.825.1796 or erin.bocherer@fahlgren.com. ...
Drug questions dog patients, doctors
Gainesville Times - Gainesville,GA,USA
... In October, Merck voluntarily pulled its popular arthritis drug Vioxx off the market after studies showed it could raise the risk of heart attacks. ...Dimethaid intends to fill Vioxx void
The Globe and Mail - Toronto,ON,Canada
... has a rare opportunity to fill the void left by the recall of arthritis blockbuster Vioxx and safety concerns swirling around Celebrex. ...
FDA Fix No. 2: Power Up The FDA
Forbes - USA
NEW YORK - When Vioxx was withdrawn from the market for doubling the risk of heart attack and stroke, it came as a shock. Its withdrawal ...Public Citizen Launches WorstPills.org, a Comprehensive Online ...
PharmaLive.com (press release) - Newtown,PA,USA
... For example, in April 2001, Public Citizen warned consumers against taking Vioxx because it increases the risk of heart attack. ...
Health advice has serious side effects
Concord Monitor - Concord,NH,USA
kind of miss seeing Dorothy Hamill glide across the surface of those Vioxx commercials on her silver blades. The Gold Medal winner ...
'Old standby' pain meds may ease osteoarthritis
Pioneer Press (subscription) - St. Paul,MN,USA
Q. QAfter Vioxx was removed from the market, my doctor switched me to Celebrex. ... Vioxx and Bextra are stronger blockers of COX-2 than Celebrex. ...
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.
http://pubs.acs.org/cen/news/83/i02/8302vioxx.html
