Useless?

I just took Celebrex and I have to say, it did absolutely nothing. I'm not sure what the hubbub is, but I think Paracetamol works better.

Celebrex Commercial Draws Criticism

Celebrex Commercial Draws Criticism
NEW YORK TIMES

Article Tools Sponsored By
By STEPHANIE SAUL
Published: April 10, 2007

A new television advertisement for Pfizer’s painkiller Celebrex that has attracted attention for both its length and innovative marketing approach is now also the target of criticism for its message.

Public Citizen, a consumer group, asked the Food and Drug Administration this morning to ban the Celebrex television commercial, alleging that it gives consumers a false impression that the prescription drug has no more safety risk than some other painkillers.

Celebrex is in the same class of drugs as the Merck pill Vioxx, which was withdrawn in 2004 because of its link to cardiovascular problems. At that time, the F.D.A. also asked Pfizer to suspend its television advertising for Celebrex.

The new Celebrex ad, which is also viewable on a Pfizer Web site celebrex.com represents a return to television for the product following a hiatus of more than two years. It had its premier last Monday evening on “World News With Charles Gibson” on ABC.

It is unusual for its length — two-and-a-half minutes rather than the usual 30- to 60-second spots — and for the fact that it was the sole sponsor of the ABC newscast, meaning that there were fewer commercial interruptions and fewer minutes over all devoted to advertising. It was the only ad during last Monday’s program.

Mr. Gibson announced that the new format with less advertising would be repeated on several Mondays this month.

Pfizer has also bought tonight’s and next Monday’s “World News” broadcast, although it is not yet clear whether the Celebrex ad will be used in either case.

The ad uses animated line drawings rather than actors, with a voice-over narrator who spends much of the time comparing Celebrex with the safety of other painkillers and discusses the risks associated with it use.

A Pfizer executive today defended the advertisement. “We do feel that this ad is a very responsible approach to talking about a medicine, and clearly a medicine that is an important thing for many, many patients to be thinking about and talking to their doctors about,” said Dr. Gail Cawkwell, the senior medical director for Pfizer.

Dr. Cawkwell said the allegations by Dr. Sidney M. Wolfe, director of Public Citizen’s Health Research Group, were wrong in several respects.

She said that his letter suggested, for example, that the ad compared Celebrex to over-the-counter medications, but that it never did. She also said that the ad clearly stated the gastrointestinal risks of Celebrex, while Dr. Wolfe suggests that those risks are played down.

Dr. Wolfe, in his letter to the F.D.A. commissioner, Dr. Andrew C. von Eschenbach, said that the ad violated the law because it contained “false or misleading statements” that might lead consumers to underestimate the risks of Celebrex and use it instead of safer painkillers that are just as effective.

“The overall purpose of the ad is to make it appear, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are not greater than those of any of the other Nsaid painkillers,” the letter said, referring to nonsteroidal anti-inflammatory drugs. “Further, it asserts that certain gastrointestinal problems are, if anything, less frequent with Celebrex than with two popular over-the-counter (OTC) painkillers.”

In an interview, Dr. Wolfe said “the safest, in terms of cardiovascular risk, is naproxen” — a reference to an over-the-counter drug that is sold as Aleve, among other brand names, as well as by prescription.

“There’s no question that Celebrex has an increased cardiovascular risk,” Dr. Wolfe said. “It’s trying to bathe Celebrex in the same bath that these others are.”

Celebrex and Vioxx belong to a category that are a subset of Nsaids drugs — a category known as Cox-2 — originally intended to avoid some of the potential for stomach irritation and other gastrointestinal side effects common with Nsaids.

But clinical studies in patients did not ultimately show a protection against ulcers and bleeding with Celebrex. Dr. Wolfe’s letter contends that a thorough review of all randomized controlled trials indicates that the Cox-2 drugs, including Celebrex, do pose an increased risk of heart attacks and other cardiovascular problems. The American Heart Association recently concluded that important differences exists in the risks of the Nsaid drugs, although it said that all the drugs required more study.

Because of the differences, the heart association recommends a hierarchy for pain treatment of people with known cardiovascular disease or risk factors. Naproxen is the association’s preferred choice among Nsaids. The group recommends that the Cox-2 drugs be the last choice, and to be used for those people who fail to respond to the older Nsaids or other drugs.

Pfizer is currently running a large clinical trial comparing Celebrex, naproxen and ibuprofen in high-risk patients.

Dr. Steven E. Nissen, the lead investigator on that trial, said today that he did not approve of consumer advertising of pharmaceuticals. But Dr. Nissen, the chairman of cardiovascular medicine at Cleveland Clinic, said he believed that the Celebrex ad was presented in a responsible fashion.

Mercky waters for Celebrex, Vioxx and Bextra

Mercky waters

AMERICAN PHARMACEUTICAL GIANT MERCK faces an uncertain future and the prospect of an avalanche of lawsuits after a US jury found the company liable for the death of a man who took its painkiller Vioxx. It’s not the first time corporate liability has severely undermined a major US company. Many observers have likened Merck’s position to that of Pan Am, Philip Morris or Ford, where a series of lawsuits threw their businesses into turmoil.

Hundreds of claims have since been filed against Merck around the world, after a court in Texas awarded US$253 million award to the widow of a man who took the once popular drug. More than 4000 Vioxx-related cases have been filed already, and lawyers say they expect between 20,000 and 100,000 will follow. More than 20 million people had taken the painkiller before the company pulled the drug from the market last September. Vioxx had annual sales of US$2.5 billion before the withdrawal.

Merck representatives in the UAE were tight-lipped last week as to how many people have been taking the drug across the region.

Vioxx belongs to a category of anti-inflammatory known as Cox-II inhibitors — along with Bextra and Celebrex made by Pfizer — when they first came on the market it was believed they would revolutionise pain relief, offering the benefits of aspirin, without the older drugs risk of stomach ulcers. Elderly people suffering from arthritis were the main patients, but doctors also prescribed it for other kinds of pain, such as that caused by sports injuries. However concerns have been raised after research linked the drugs to heart attacks and bleeding of the gut.

Similar concerns have also been raised about Bextra and Celebrex. Pfizer stopped selling Bextra in April, while Celebrex remains on the market for now but has a prominent warning of its heart dangers. Lawsuits have been filed over both drugs. Merck shares have fallen about 33% since Vioxx was withdrawn from the market in September. Meanwhile, Merck’s market value has plunged about US$30 billion. Analysts predict a total payout of between US$4 billion and $30 billion.

It is not the first time a corporate liability crisis has threatened to undermine the foundations of a major American corporation. Tobacco giant Philip Morris even changed its name to the Altria Group, after a deluge of lawsuits. This followed the tobacco industry’s US$206 billion settlement in 1998 with 46 state governments trying to recoup the cost of caring for sick smokers. In early 1999, the company faced 670 suits filed by smokers and others. Despite the soaring stock market, the company’s stock plunged about 57% in 1999, making it the worst performing stock in the Dow Jones Industrial Average. Philip Morris executives even seriously considered filing for bankruptcy-court protection in 2003.

Meanwhile in 2001, the reputation of automaker Ford took a battering when the United States’ National Highway Traffic Safety Administration noted a high incidence of tyre failure on Ford Explorers fitted with Firestone tyres. Ford investigated and found that several models of 15’’ Firestone tyres had very high failure rates, especially those made at Firestone’s Decatur, Illinois plant. The plant was eventually closed. The failures all involved tread separation — the tread peeling off followed often by tyre disintegration.

If that happened at speed, there was a high likelihood of the vehicle would leave the road and roll over. It has been estimated that this failure caused over 250 deaths and more than 3,000 serious injuries. A large number of lawsuits have been filed against both Ford and Firestone, some unsuccessful, some settled out of court, and a few successful. Lawyers estimated Ford and Firestone paid between US$3 million and US$6 million in the majority of cases where a death was involved.

Perhaps the most notorious corporate liability collapse involved Pan Am. After a series of security concerns the airline was finally bankrupted after one of its planes, a Boeing 747 exploded in mid-flight over Lockerbie, Scotland, in 1988, due to a bomb in its cargo hold. All people on board were killed as well as eleven people on the ground. It was a major blow to an already weakened airline. Pan Am’s iconic image had already made it a target for terrorists, and the carrier had already succumbed to a number of high profile security lapses. After the Lockerbie disaster it fell apart.

Faced with a US$300 million lawsuit filed by more than 100 families of the victims, the airline subpoenaed records of six US government agencies, including the CIA, the Drug Enforcement Administration, and the State Department. Though the records suggested that the US government was aware of warnings of a bombing and failed to pass the information to the airline, the families claimed that Pan Am was attempting to shift the blame. In 1991, Pan Am declared bankruptcy.

However, one US firm to so far avoid any lasting damage from liability claims has been McDonald’s. In 2003, a federal judge threw out a class-action lawsuit by two US teenagers who claimed the fast food restaurant used false advertising and that the chain’s food made them fat and contributed to their health problems. The plaintiffs’ lawyers claimed unknown ingredients and processing made McDonald’s food damaging to consumers’ health. But the judge ruled that consumers who choose to eat at the hamburger chain could not simply blame McDonald’s if they put on weight as a result. Had the teenagers won, a deluge of similar suits would surely have followed. At least once corporate giant lives on. Merck may not be so lucky.

Pfizer's Celebrex the cause of possible cardiovascular risks

Pfizer's Celebrex the cause of possible cardiovascular risks

But the company on Monday also said U.S. regulators had approved a new use for the drug, treating ankylosing spondylitis, a form of arthritis of the spine that Pfizer said affects more than 400,000 Americans.
Pfizer Inc. on Monday said the label of its Celebrex arthritis drug has been changed to add a prominent warning of possible cardiovascular risks, such as an increased chance of heart attacks, in line with new warnings on other arthritis and pain drugs.

The label will also carry a new warning that Celebrex, like older painkillers, can cause serious ulcers and gastrointestinal bleeding.

Celebrex was developed to treat pain with a far lower risk of such bleeding than older treatments. But in a large clinical trial, Celebrex failed to prove significantly safer for the stomach than a far cheaper standard painkiller.

Pfizer said the package insert label of the drug recommends it be prescribed "at the lowest effective dose for the shortest duration." But the company on Monday also said U.S. regulators had approved a new use for the drug, treating ankylosing spondylitis, a form of arthritis of the spine that Pfizer said affects more than 400,000 Americans.

"The fact that the FDA gave us a new indication shows they are confident in the safety of Celebrex," said Pfizer spokeswoman Mariann Caprino.

Celebrex has been one of the company's biggest products, though its sales have recently declined sharply due to safety concerns.

Second-quarter revenue from Celebrex plunged 45 percent to $401 million - one reason the world's largest drug maker expects a modest decline in company revenue this year.

A federal advisory panel of doctors in February said Celebrex "significantly" raised the risk of heart problems and strokes. But the advisers to the U.S. Food and Drug Administration recommended it remain on the market because of its benefits to arthritis patients.

Pfizer is adding the new "black box" warnings at the request of the FDA. The agency has also asked the makers of dozens of other prescription and non-prescription painkillers - including Motrin, Advil and Aleve - to strengthen warnings about possible heart risks and potentially life-threatening gastrointestinal bleeding.

The new warnings do not apply to aspirin.

New York-based Pfizer in April withdrew a similar arthritis drug, Bextra, after U.S. and European regulators said the risk of side effects, including a potentially fatal skin allergy, outweighed its benefits.

Pfizer last month said its sales forces was holding back on fully promoting Celebrex again until it knew the warning language the FDA would require on the drug's label.

Safety concerns about Celebrex and other painkillers intensified after Merck & Co. Inc. withdrew its Vioxx arthritis treatment in September when it was shown to double the risk of heart attack and stroke after long-term use.

Celebrex and Vioxx both work by selectively blocking an inflammation-causing protein called Cox-2; but in doing so, some scientists believe the drugs also increase the risk of blood clots that cause heart attacks and stroke.

Pfizer shares were up 23 cents to $26.73 in afternoon trading on the New York Stock Exchange, in line with gains for the drug sector.

Penn Study Points to New Evidence to Explain How COX-2 Inhibitors Can Eventually Lead to Heart Disease and Stroke

Tue May 24 14:01:28 2005 Pacific Time
Penn Study Points to New Evidence to Explain How COX-2 Inhibitors Can Eventually Lead to Heart Disease and Stroke

PHILADELPHIA, May 24 (AScribe Newswire) -- University of Pennsylvania School of Medicine researchers have found additional evidence that may help explain how selective inhibitors of COX-2 might predispose individuals to heart disease and stroke. In Circulation Research, they report that a COX-2-derived fatty substance -- a prostaglandin called prostacyclin -- controls the blood-vessel response to stresses such as high-blood pressure, thereby further linking COX-2 inhibitors to an increased risk of heart attack or stroke. This knowledge, along with a growing literature on physiological responses to COX-2 inhibitors, should help in the development of a rational approach to clinical risk management for this class of drugs.

Two randomized trials of COX-2 inhibitors -- the gold standard of clinical evidence -- conducted in 2004 at other institutions suggested that risk of cardiovascular disease might increase gradually during continued treatment with drugs such as Celebrex and Vioxx, even in individuals initially at low risk of the disease.

"The risk of heart attack and stroke became progressively evident during treatment with either Celebrex or Vioxx during the APPROVe and APC trials last year," says Garret FitzGerald, MD, lead author of the study published online this week. FitzGerald is the Director of the Institute for Translational Medicine and Therapeutics at Penn.

These studies were designed to determine whether COX-2 inhibitors limited the development of benign growths in the large bowel of patients who -- to the best of study authors' knowledge -- were at low risk of heart disease. "While the results of these trials are not conclusive, they are compatible with a gradual transformation of increased cardiovascular risk during continued dosing with either Celebrex or Vioxx," says FitzGerald. "We need to determine how this might occur, and whether we can manage this risk by developing tests that reflect the process."

Earlier animal studies by Penn researchers and others showed that suppression of the protective fat prostacyclin, which is made by COX-2, could predispose individuals to a rise in blood pressure which, in turn, can accelerate hardening of the arteries, or atherosclerosis. COX-2 inhibitors such as older NSAIDs have been shown to raise blood pressure in people. In addition, the Penn group has shown in previous studies that shutting down prostacyclin hastens initiation and early development of atherosclerosis.

The current research expands on this notion. R. Daniel Rudic, PhD, and Derek Brinster, MD, and others in FitzGerald's laboratory, report that COX-2-derived prostacyclin also controls the changes that occur in the muscular lining of blood vessels in response to pressure-related changes in blood flow.

They used two animal models to test their ideas. In one, they looked at changes in a blood vessel that had been transplanted into mice of a different genetic make-up; in fact, the model mimicks the events of human organ transplant rejection. Here, they found that they had, in effect, removed a brake on the response of the blood vessel to the challenge of transplantation by deactivating prostacyclin by genetically deleting its receptor. The result was that muscle cells proliferated dramatically, which normally reduces the openness of the blood vessel. However, the openness of the blood vessel was not changed, through a process of structural reorganization of the blood vessel called vascular remodeling.

In the second model, they reduced blood flow in arteries in the neck and looked at the downstream effects in the blood vessel. This time, instead of suppressing prostacyclin receptor signaling by genetic deletion, they did so by giving a COX-2 inhibitor. Indeed, they saw the same effect. Cells in the muscular lining of the vessel wall multiplied (just like in the transplant model). Additionally, despite the vessel growth caused by the COX-2 inhibitor, openness of the blood vessel was again preserved. This occurred despite lower blood flow caused by the COX-2 inhibitor. Thus, prostacylin may act to remodel blood vessels to preserve adequate blood flow.

"What is really convincing here is how similarly the two models responded and how the genetics of the pharmacological approach to disrupting the effects of COX-2 had the same effect," says Rudic. Further studies -- also described in the paper and performed in collaboration with Thomas Coffman, of Duke University-FitzGerald's group -- showed that the consequences of shutting down COX-2-derived prostacyclin could be limited, in part, by removing a receptor activated by thromboxane A2, the fatty product of COX-1 in platelets. This mirrors a similar balancing effect between COX-1 and COX-2, which has been noted in the case of blood clotting, blood pressure, and atherosclerosis. This suggests that suppression of thromboxane with low-dose aspirin could reduce the risk of heart disease if taking COX-2 inhibitors.

These findings suggest that during prolonged dosing with COX-2 inhibitors, several consequences of drug action -- a rise in blood pressure, initiation, and early development of atherosclerosis, and now the architectural and functional response of blood vessels to such stress -- could all interact in a reinforcing fashion to transform the risk of heart attack and stroke, even in previously healthy individuals. "We need to determine whether these mechanisms are operative in people, and if so, we should be able to develop tests which reflect this process," says FitzGerald. "This may allow us to detect the small number of individuals at risk of rapidly developing heart disease and stop the drugs before they run into trouble. We could also determine how quickly risk might dissipate on stopping the drugs. Certainly, the development of a rational approach to risk management will be key to giving Celebrex or other COX-2 inhibitors safely, even to healthy patients, for extended periods."

The study was funded in part by the National Institutes of Health. Study co-authors Yan Cheng, Susanne Fries, Wen Liang Song, and Sandra Austin are from Penn, as well as Thomas M. Coffman from Duke University. This release can also be found at: http://www.uphs.upenn.edu/news .

- - - -

CONTACT: Karen Kreeger, UPHS Media Relations, 215-349-5658, karen.kreeger@uphs.upenn.edu

ABOUT PENN MEDICINE

PENN Medicine is a $2.7 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System.

Penn's School of Medicine is ranked #3 in the nation for receipt of NIH research funds; and ranked #4 in the nation in U.S. News & World Report's most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

The University of Pennsylvania Health System includes three owned hospitals [Hospital of the University of Pennsylvania, which is consistently ranked one of the nation's few "Honor Roll" hospitals by U.S. News & World Report; Pennsylvania Hospital, the nation's first hospital; and Presbyterian Medical Center]; a faculty practice plan; a primary-care provider network; two multispecialty satellite facilities; and home care and hospice.

Media Contact: Karen Kreeger, 215-349-5658, karen.kreeger@uphs.upenn.edu

Hundreds of Attorneys, Medical Experts Gather to Discuss Implications of Bextra and Celebrex; Heavyweights to Discuss Developments, Legal Action at Mealey's Bextra and Celebrex Litigation Conference Sponsored by LexisNexis

DAYTON, Ohio--(BUSINESS WIRE)--April 19, 2005--On the heels of Vioxx litigation, legal claims surrounding prescription arthritis drugs are expected to soar following Pfizer's recent suspension of Bextra sales and continued FDA scrutiny of Celebrex. LexisNexis(R) U.S., a leading provider of legal, news and business information services, will host a symposium next month to help plaintiff and defense attorneys prepare to address these issues. The Mealey's Bextra and Celebrex Litigation Conference will be held on May 11 at the Fairmont Hotel in Chicago.

In addition to plaintiff and defense attorneys, physicians, pharmacologists, legislators and financial analysts will be in attendance at this one-day conference. A sampling of topics to be addressed at the conference includes:

-- Bextra and Celebrex history, clinical studies and adverse effects

-- Cardiology issues associated with the use of Bextra and Celebrex

-- The link between Bextra use and Stevens Johnson Syndrome

-- FDA legal and regulatory issues including the recently established Drug Monitoring board

-- Effectiveness of prescription label warnings and liability

-- Theories of liability and defense including causation

For registration information on the Mealey's Bextra and Celebrex Litigation Conference, visit www.mealeys.com/conferences or call 1-800-MEALEYS.

About LexisNexis

LexisNexis(R) U.S. (www.lexisnexis.com) is a leader in comprehensive and authoritative legal, news and business information and tailored applications. A member of Reed Elsevier Group plc (NYSE:ENL)(NYSE:RUK) (www.reedelsevier.com), the company does business in 100 countries with 13,000 employees worldwide. In addition to its flagship Web-based Lexis(R) and Nexis(R) research services, the company includes some of the world's most respected legal publishers such as Martindale-Hubbell, Matthew Bender, Butterworths, Les Editions du Juris-Classeur, Abeledo-Perrot and Orac.

Pfizer earnings fall as effect of publicity over painkillers is felt

By Stephanie Saul The New York Times

Thursday, April 21, 2005

Pfizer, the world's largest drug maker, has reported sharply lower first-quarter earnings, partly because of the fallout over its controversial Cox-2 inhibitor painkillers, Bextra and Celebrex. The company said on Tuesday that it took a $766 million charge related to the withdrawal of Bextra from the market and reported lower sales of its other arthritis drug, Celebrex.

A rival health care company, Johnson & Johnson, meanwhile, reported a doubt-digit earnings increase on record sales, driven largely by strong growth in its medical devices business. Johnson & Johnson also increased its earnings guidance for the year.

Pfizer, which is based in New York, earned $301 million, or 4 cents a share, a drop of 87 percent from the $2.33 billion, or 31 cents a share, it earned in the first quarter of 2004. The company said that in addition to its Cox-2 problems, results this year would be affected by the loss of U.S. exclusivity on four major drugs - Diflucan, Neurontin and Accupril last year and Zithromax in 2005.

But the picture was not all gloomy, thanks largely to continuing double-digit growth of the cholesterol-lowering drug Lipitor, one of the world's top-selling medicines. Sales increased 23 percent, to $3.075 billion, in the first quarter.

Pfizer's overall sales increased nearly 5 percent, to $13.09 billion. Without one-time charges, its earnings were $4 billion, or 54 cents a share, exceeding Wall Street expectations by 1 cent.

Pfizer earnings fall as effect of publicity over painkillers is felt
New Feature

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By Stephanie Saul The New York Times

Thursday, April 21, 2005
Pfizer, the world's largest drug maker, has reported sharply lower first-quarter earnings, partly because of the fallout over its controversial Cox-2 inhibitor painkillers, Bextra and Celebrex.
.
The company said on Tuesday that it took a $766 million charge related to the withdrawal of Bextra from the market and reported lower sales of its other arthritis drug, Celebrex.
.
A rival health care company, Johnson & Johnson, meanwhile, reported a doubt-digit earnings increase on record sales, driven largely by strong growth in its medical devices business. Johnson & Johnson also increased its earnings guidance for the year.
.
Pfizer, which is based in New York, earned $301 million, or 4 cents a share, a drop of 87 percent from the $2.33 billion, or 31 cents a share, it earned in the first quarter of 2004. The company said that in addition to its Cox-2 problems, results this year would be affected by the loss of U.S. exclusivity on four major drugs - Diflucan, Neurontin and Accupril last year and Zithromax in 2005.
.
But the picture was not all gloomy, thanks largely to continuing double-digit growth of the cholesterol-lowering drug Lipitor, one of the world's top-selling medicines. Sales increased 23 percent, to $3.075 billion, in the first quarter.
.
Pfizer's overall sales increased nearly 5 percent, to $13.09 billion. Without one-time charges, its earnings were $4 billion, or 54 cents a share, exceeding Wall Street expectations by 1 cent.
.
In a news release, the chief executive, Henry McKinnell Jr., characterized the company's performance as steady, but he said 2005 would be a transitional year.
.
Bextra was withdrawn from the market this month, but negative publicity surrounding the Cox-2 inhibitors had already led to a sales decline in the first quarter. Bextra revenue dropped to $56 million, 79 percent less than the $270 million in the first quarter of 2004.
.
The Food and Drug Administration asked Pfizer to stop selling Bextra because of its link to a rare but serious skin disorder. Pfizer said it disagreed with the agency's risk-benefit analysis of Bextra and was meeting with regulators in an effort to resume sale of the drug.
.
Celebrex remains on the market, but its sales were down to $411 million, the company said, as consumers and physicians focused on reports about heart risks associated with drugs in the Cox-2 class. In the first quarter of 2004, Pfizer sold $769 million of Celebrex.
.
Johnson & Johnson's record sales of $12.83 billion, up 11 percent, reflected stronger performance by medical devices as well as continued growth in some of its pharmaceutical products. Net income was $2.93 billion, or 97 cents a share, compared with $2.49 billion, or 83 cents a share, in the year-earlier period.
.
Sales of Remicade, used to treat autoimmune disorders, were up 22 percent, to $501 million. Sales of the company's antipsychotic drug Risperdal grew 16 percent, to $844 million. Revenue from its epilepsy drug Topamax increased 24 percent, to $406 million.
.
.
See more of the world that matters - click here for home delivery of the International Herald Tribune.
.
< < Back to Start of Article
Pfizer, the world's largest drug maker, has reported sharply lower first-quarter earnings, partly because of the fallout over its controversial Cox-2 inhibitor painkillers, Bextra and Celebrex.
.
The company said on Tuesday that it took a $766 million charge related to the withdrawal of Bextra from the market and reported lower sales of its other arthritis drug, Celebrex.
.
A rival health care company, Johnson & Johnson, meanwhile, reported a doubt-digit earnings increase on record sales, driven largely by strong growth in its medical devices business. Johnson & Johnson also increased its earnings guidance for the year.
.
Pfizer, which is based in New York, earned $301 million, or 4 cents a share, a drop of 87 percent from the $2.33 billion, or 31 cents a share, it earned in the first quarter of 2004. The company said that in addition to its Cox-2 problems, results this year would be affected by the loss of U.S. exclusivity on four major drugs - Diflucan, Neurontin and Accupril last year and Zithromax in 2005.
.
But the picture was not all gloomy, thanks largely to continuing double-digit growth of the cholesterol-lowering drug Lipitor, one of the world's top-selling medicines. Sales increased 23 percent, to $3.075 billion, in the first quarter.
.
Pfizer's overall sales increased nearly 5 percent, to $13.09 billion. Without one-time charges, its earnings were $4 billion, or 54 cents a share, exceeding Wall Street expectations by 1 cent.
.
In a news release, the chief executive, Henry McKinnell Jr., characterized the company's performance as steady, but he said 2005 would be a transitional year.
.
Bextra was withdrawn from the market this month, but negative publicity surrounding the Cox-2 inhibitors had already led to a sales decline in the first quarter. Bextra revenue dropped to $56 million, 79 percent less than the $270 million in the first quarter of 2004.
.
The Food and Drug Administration asked Pfizer to stop selling Bextra because of its link to a rare but serious skin disorder. Pfizer said it disagreed with the agency's risk-benefit analysis of Bextra and was meeting with regulators in an effort to resume sale of the drug.
.
Celebrex remains on the market, but its sales were down to $411 million, the company said, as consumers and physicians focused on reports about heart risks associated with drugs in the Cox-2 class. In the first quarter of 2004, Pfizer sold $769 million of Celebrex.
.
Johnson & Johnson's record sales of $12.83 billion, up 11 percent, reflected stronger performance by medical devices as well as continued growth in some of its pharmaceutical products. Net income was $2.93 billion, or 97 cents a share, compared with $2.49 billion, or 83 cents a share, in the year-earlier period.
.
Sales of Remicade, used to treat autoimmune disorders, were up 22 percent, to $501 million. Sales of the company's antipsychotic drug Risperdal grew 16 percent, to $844 million. Revenue from its epilepsy drug Topamax increased 24 percent, to $406 million.
.
.
See more of the world that matters - click here for home delivery of the International Herald Tribune.
.
< < Back to Start of Article
Pfizer, the world's largest drug maker, has reported sharply lower first-quarter earnings, partly because of the fallout over its controversial Cox-2 inhibitor painkillers, Bextra and Celebrex.
.
The company said on Tuesday that it took a $766 million charge related to the withdrawal of Bextra from the market and reported lower sales of its other arthritis drug, Celebrex.
.
A rival health care company, Johnson & Johnson, meanwhile, reported a doubt-digit earnings increase on record sales, driven largely by strong growth in its medical devices business. Johnson & Johnson also increased its earnings guidance for the year.
.
Pfizer, which is based in New York, earned $301 million, or 4 cents a share, a drop of 87 percent from the $2.33 billion, or 31 cents a share, it earned in the first quarter of 2004. The company said that in addition to its Cox-2 problems, results this year would be affected by the loss of U.S. exclusivity on four major drugs - Diflucan, Neurontin and Accupril last year and Zithromax in 2005.
.
But the picture was not all gloomy, thanks largely to continuing double-digit growth of the cholesterol-lowering drug Lipitor, one of the world's top-selling medicines. Sales increased 23 percent, to $3.075 billion, in the first quarter.
.
Pfizer's overall sales increased nearly 5 percent, to $13.09 billion. Without one-time charges, its earnings were $4 billion, or 54 cents a share, exceeding Wall Street expectations by 1 cent.
.
In a news release, the chief executive, Henry McKinnell Jr., characterized the company's performance as steady, but he said 2005 would be a transitional year.
.
Bextra was withdrawn from the market this month, but negative publicity surrounding the Cox-2 inhibitors had already led to a sales decline in the first quarter. Bextra revenue dropped to $56 million, 79 percent less than the $270 million in the first quarter of 2004.
.
The Food and Drug Administration asked Pfizer to stop selling Bextra because of its link to a rare but serious skin disorder. Pfizer said it disagreed with the agency's risk-benefit analysis of Bextra and was meeting with regulators in an effort to resume sale of the drug.
.
Celebrex remains on the market, but its sales were down to $411 million, the company said, as consumers and physicians focused on reports about heart risks associated with drugs in the Cox-2 class. In the first quarter of 2004, Pfizer sold $769 million of Celebrex.
.
Johnson & Johnson's record sales of $12.83 billion, up 11 percent, reflected stronger performance by medical devices as well as continued growth in some of its pharmaceutical products. Net income was $2.93 billion, or 97 cents a share, compared with $2.49 billion, or 83 cents a share, in the year-earlier period.
.
Sales of Remicade, used to treat autoimmune disorders, were up 22 percent, to $501 million. Sales of the company's antipsychotic drug Risperdal grew 16 percent, to $844 million. Revenue from its epilepsy drug Topamax increased 24 percent, to $406 million.

Celebrex Pharmeceutical Lawsuits

Celebrex?

The use of Celebrex and Vioxx may be linked to an increased rate of heart attacks, strokes, and blood clots. Both Celebrex and Vioxx are from a new class of arthritic drugs called COX-2 inhibitors that emerged in the late 1990s. Though these drugs have been praised for reduced gastrointestinal side effects when compared to the older non steroidal anti-inflammatory drugs such as aspirin or Aleve, studies have shown that they may carry a higher risk for heart problems and the same risk for kidney problems.

Vioxx has also been linked to a total of 12 cases of nonbacterial meningitis (an inflammation of the membrane coverings of the brain). While most of the research has been done relates to Vioxx, experts believe that other COX-2 inhibitors, including Celebrex, would carry the same risks.

Celebrex Frequently Asked Questions

What is Celebrex used for?

Celebrex is used to:

» relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis in adults.
» reduce the number of colorectal polyps in patients with Familial Adenomatous Polyposis (FAP). FAP is an inherited disorder in which the rectum and colon are covered with many polyps. Celebrex should be used along with the usual care for FAP patients such as surgery and monitoring of the lower gastrointestinal tract.
» Celebrex has not been shown to reduce colorectal, duodenal or other FAP-related cancers. It is not known whether the effects of Celebrex will last after treatment is stopped. The efficacy and safety of Celebrex treatment in FAP patients beyond six months has not been studied. Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of Celebrex. In particular, the frequency of routine endoscopic surveillance should not be decreased and prophylactic colectomy or other FAP-related surgeries should not be delayed.
» Acute pain in adults
» Painful menstrual cycles

Who should not take Celebrex?

You should not take Celebrex if you:

» have had an allergic-type reaction to sulfa drugs
» have had asthma, hives or allergic-type reactions after taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs). A few examples of NSAIDs are ibuprofen, naproxen, diclofenac, nabumetone, and ketoprofen.

What are the special warnings concerning the use of Celebrex?

Serious problems from stomach ulcers such as bleeding are recognized complications in people treated with NSAID's. Similar problems have occurred in people treated with Celebrex, although very rarely. The likelihood of stomach problems increases the longer you take drugs like Celebrex. However, even short-term treatment is not without risk. These problems can happen without any warning, but in some people may cause symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens, stop taking Celebrex and call your health care provider right away.

Check with your health care provider. Celebrex may not be right for you, if you:

» have had ulcers or stomach bleeding
» have had asthma, hives or allergic-type reactions after taking aspirin or other NSAIDs
» have severe kidney problems
» have severe liver problems
» are pregnant

What are the general precautions concerning the use of Celebrex?

Do not stop taking any medications that you have been prescribed without first talking to you doctor.

Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If this happens call your health care provider right away.

Celebrex can cause fluid retention and swelling in some patients. Check with your health care provider to see if Celebrex is right for you, if you:

» retain fluids
» have high blood pressure
» have heart failure

If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since such reactions to aspirin and other NSAIDs have occurred in aspirin-sensitive patients, Celebrex should not be given to aspirin-sensitive patients.

The safety and effectiveness of Celebrex in patients below the age of 18 years has not been determined.

Avoid taking Celebrex with antacids that contain calcium carbonate and magnesium/aluminum combination products, because they may reduce the amount of Celebrex your body absorbs.

What should I tell my doctor or health care provider?

» Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.
» Because certain medications may interact with NSAIDs or Celebrex, review all medications that you take with your health care provider, including those that you take without a prescription.
» Your health care provider may have to adjust your dose or monitor you more closely if you take:

• certain blood pressure medications called ACE-inhibitors
• furosemide
• fluconazole
• lithium
• warfarin
• aspirin

What are some possible side effects of Celebrex?

This is NOT a complete list of side effects reported with Celebrex. Your health care provider can discuss with you a more complete list of side effects.

Side effects can include:

» Headache
» Indigestion
» Upper respiratory tract infection
» Diarrhea
» Sinus inflammation
» Stomach pain
» Nausea

Rarely serious ulcers have occurred in patients taking Celebrex.

For more detailed information about Celebrex, ask your health care provider.