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WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today. Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in...

Pfizer BrandsPrescription Aricept® (donepezil hydrochloride tablets) Bextra® (valdecoxib) Celebrex® (celecoxib) Lipitor® (atorvastatin calcium) tablets Relpax® (eletriptan HBr) Viagra® (sildenafil citrate) tablets Viracept® (nelfinavir mesylate) Xalatan® (latanoprost ophthalmic solution) Zoloft® (sertraline HCl) Zyrtec® (cetirizine HCl) Over-the-Counter Brands Benadryl Listerine Mouthwash Listerine PocketPaks Neosporin Purell Rogaine Rolaids Sudafed Visine Zantac Lets face it, if Pfizer had not wanted the land, then the SC never would have made the ruling. Hit Pfizer where it hurts, in the pocketbook.

Does anyone read warning labels anymore? Did you know, for instance, that the Prozac warning label cautions a "risk of suicidal thinking and behavior"? And you thought Prozac was merely an anti-depressant. Prozac, states its warning, also may induce "nausea, nervousness, weakness, loss of appetite, tremors, dry mouth, sweating, decreased sex drive, impotence, or yawning." Obviously millions of patients accept those hazards because the benefits outweigh the risks. Impotence? What about erectile dysfunction drugs? You've heard the warning: Sometimes the stuff works exceedingly well - for four straight hours, even. The patient is then left with an uncomfortable decision of...

Can a dietary supplement pick up the pieces? Glucosamine, often recommended for joint pain, is one of the most popular supplements on the market. And considering the health concerns recently associated with nonsteroidal anti-inflammatory medications, I thought it would be worth looking into whether glucosamine lives up to the hype.Background: Glucosamine and chondroitin are often combined together and used to treat osteoarthritis (OA), which occurs when the cartilage covering the end of the bone near the joint breaks down. OA affects the knees, backs, hips, hands and feet of more than 21 million people over age 45. And, according to...

<p>Catch up with the car from "Back to the Future"</p> <p>Bextra belongs to a class of drugs that has been linked to higher risk of cardiovascular disease, but the reason given by both the government and Pfizer for today's withdrawal of Bextra was an additional risk of a potentially serious skin reaction.</p>

Fri Feb 25, 4:03 PM ET A study by the Center for Science in the Public Interest indicates that 10 of the 32 panel members had ties to either Pfizer Inc. or Merck & Co., ranging from consulting fees and speaking honoraria to research support. The FDA issued a statement saying it screened members of the panel for conflicts of interest. "This transparent process requires the agency to carefully weigh any potential financial interest with the need for essential scientific expertise in order to protect and advance the public health," the agency said. After three days of hearings on the...

After a panel of medical experts gave a very cautious nod to the continued use of the painkillers Celebrex, Vioxx and Bextra on Friday, pain management experts said they expected to see the same caution transform the way the painkillers are prescribed from now on. The drugs, which had been hugely popular for people with both short-term and chronic pain, will be prescribed much less readily, for a smaller group of patients, at lower doses and for shorter periods, the experts said. "I am still very concerned about the cardiac risks of these medications," said Dr. David Campen, director of...

WASHINGTON, Feb. 18 - A federal drug advisory panel unanimously agreed today that the huge-selling painkillers Celebrex, Bextra and Vioxx cause worrisome heart problems, but its members voted to recommend that all three nonetheless be available to patients, accompanied by strong warnings of the risks. The panel only narrowly supported the continued marketing of Pfizer's Bextra or the return of Merck's Vioxx, voting 17-13 on Bextra and 17-15 on Vioxx. The panel was much more comfortable supporting the continued marketing of Celebrex, favoring the Pfizer painkiller 31-1. The Food and Drug Administration, which has the final word on the regulation...

As a person who can use no other anti-inflamatory drug I would appreciate some assistance in telling the FDA that "Public Citizen" does not represent me, or I am sure millions of others who take (or took) these drugs properly, under proper medical supervision and with the full knowledge and awareness that ALL drugs have effects that are not known at this time. Public Citizen is calling for a complete ban of these drugs because of an increased risk of "heart problems" from taking these drugs. I have never heard of this group and prefer to make my own, informed,...

Two studies released yesterday have turned up new evidence that all of the popular arthritis painkillers known as COX-2 inhibitors may put users at greater risk of heart attacks and strokes. The first of the two papers published online by the journal Circulation found that patients who had had heart bypass surgery and were taking Pfizer Inc.'s Bextra and another experimental COX-2 inhibitor were three times more likely to have strokes and heart attacks than patients taking a placebo. The statistically significant tripling of the risk showed up when researchers combined the results of two earlier studies involving more than...

By THE ASSOCIATED PRESS WASHINGTON, Dec. 9 (AP) - The government is warning of potential heart problems associated with the use of the painkiller Bextra in people who have recently had heart bypass surgery. The Food and Drug Administration said Thursday that it was adding the warning to the label of Bextra, as well as strengthening the label warnings on the possibility of severe skin reactions with the drug, which is made by Pfizer. The F.D.A. said in a statement that "results from a new study of more than 1,500 patients who had just had cardiac surgery show that patients...

WASHINGTON — At a hearing Thursday on Capitol Hill, senators excoriated top federal drug regulators for failing to realize three years ago that Vioxx, a pain pill that Merck withdrew in September, was dangerous. But the Food and Drug Administration today faces almost exactly the same situation with another arthritis drug, Bextra, that it did with Vioxx three years ago. And just as with Vioxx, it is far from clear what the agency should do. In a sign that they believe they acted appropriately in the Vioxx case, top agency officials are handling the Bextra situation exactly the same way....

FDA 'Incapable' of Protecting Public, Federal Reviewer Says The Associated Press The American public is "virtually defenseless" if another medication such as Vioxx proves to be unsafe after it is approved for sale, a government drug safety reviewer told a congressional committee Thursday. "I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx," said David Graham, who warned that the arthritis drug had been linked to an increased risk of heart attack and stroke. He told the Senate Finance Committee that there were at least five other drugs on the market today that...

In a series of testy e-mail exchanges with his bosses, a federal drug-safety reviewer contends that an effort to publish his study demonstrating the dangers of Vioxx was delayed and demeaned by top officials at the Food and Drug Administration. The e-mail and meeting notes also show that Dr. David Graham, an official in the F.D.A.'s Office of Drug Safety, is seeking to launch a study of the safety of Bextra and Mobic, two arthritis pills that are similar to Vioxx. Merck withdrew Vioxx in September after finding that it caused an increase in the risk of heart attacks. The...

Less than three weeks after Merck withdrew its arthritis painkiller Vioxx from the market because it increased the risk of heart attacks, Pfizer announced plans yesterday to test if its best-selling painkiller Celebrex, which is in the same class of drugs as Vioxx, can do the opposite - help prevent heart attacks. But Pfizer's announcement is raising questions. For one, Pfizer warned only last Friday that Bextra, another of its drugs in the same class as Vioxx and Celebrex, increased the risks of heart attack and stroke in patients undergoing coronary-bypass surgery. So the timing of the announcement of the...

Pfizer warned doctors yesterday that one of its best-selling painkillers, Bextra, might increase the risk of heart attack or stroke in coronary artery bypass surgery patients. The announcement comes just two weeks after Merck removed from the market its painkiller, Vioxx, which is in the same class of medicines as Bextra, because a study showed that the risk of heart attacks doubled for patients who had taken Vioxx 18 months or longer. Pfizer said a clinical study involving more than 1,500 patients showed that those who had undergone bypass surgery and had taken Bextra intravenously and orally were at higher...