Bextra Drug Recall
April 15, 2005 - TheWorldLink.com
By Niki Sullivan, Associated Press Writer
SALEM - A bill that would expand the number of people who can sue because of health problems caused by Vioxx and Bextra got its first hearing in the Senate Thursday.
Prior to 2004, state law required victims in such cases to file their lawsuit within two years after suffering their injury.
But for some users of Vioxx and Bextra, also known as Cox-2 inhibitors, the statute of limitations ran out before the drugs were found to cause heart disease, lobbyist Brad Higbee told the Senate Judiciary Committee.
Higbee, representing a group called Vioxx Victims United, said the deadline unfairly restricted some patients' right to sue. Representatives of the pharmaceutical industry countered that the limitations are set up to balance the rights of consumers and manufacturers.
The bill, which only deals with the Cox-2 drugs, would change the deadline for filing lawsuits to two years after the cause of an injury is discovered. For Vioxx users, that would be Sept. 30, 2004, the date it was removed from the market.
"Many here today are here because they need your help," Higbee said, referring to a panel of witnesses, some in wheelchairs.
Toni Yukert, 57, was taking Vioxx for arthritis in August 2002 when her husband found her on the floor of their home, having suffered a massive stroke.
Mike Yukert testified that his wife, who sat in a wheelchair beside him, cannot speak and is paralyzed on her right side because of the stroke he believes was caused by Vioxx.
"Imagine how frustrated you'd feel if, simply because you live in Oregon, that we cannot have our day in court," Mike Yukert said.
As many as 140,000 Americans were injured and up to 60,000 died from taking Vioxx, according to an estimate from David Graham, a drug safety researcher with the Food and Drug Administration.
In many states, those who took Cox-2 drugs and suffered from medical problems can still file a lawsuit against the drug companies.
The 2003 Legislature passed a law that said such lawsuits can be filed within two years after the cause of an injury is discovered, which is what the Vioxx users are seeking. The new deadline, however, only applied to injuries that happened after 2003.
That blocks Yukert's wife from seeking damages because her stroke happened in 2002.
Witnesses said people who took the drug more than two years before they were pulled from the market are treated unfairly because they had no way to know the cause of their heart attack or stroke by the time the statute of limitations ran out.
But Jim Gardner, a representative for the Pharmaceutical Research and Manufacturers of America, said statutes of limitation are meant to "balance a consumer's right to adequate recourse in product liability actions and a manufacturer's right to be protected from unlimited exposure to lawsuits."
Gardner also said the bill could have a "chilling effect on a prescription drug manufacturer's decision to do business in the State of Oregon," and said that current law adequately protects citizens.
The committee took no action on the bill.
April 7, 2005 - Bloomberg.com
Pfizer Inc., the world's biggest drugmaker, agreed to suspend sales of its Bextra painkiller because of heart risks, the U.S. Food and Drug Administration said today.
Pfizer will add a warning to its other painkiller, Celebrex, highlighting the potential of increased cardiovascular risks, the agency said in an e-mailed statement. Similar prescription painkillers will have to carry the same warning. Older painkillers such as aspirin will have to carry cautions about the possibility of cardiovascular and gastrointestinal risks, the agency said.
The FDA went against the advice of a panel of doctors and scientists, which in February concluded that Bextra was beneficial enough to justify its continued sale. Pfizer said in a statement that it disagrees with the FDA's decision and will hold further discussions with the agency about returning Bextra to the market.
"They stood up and defended the product saying there were no side effects, now the FDA has withdrawn it and there is a likely threat of litigation," said Karl Heinz Koch, a drug analyst at Lombard Odier Darier Hentsch in Zurich. "There will certainly be an investigation as to whether or not there was any wrongdoing by Pfizer."
Shares of New York-based Pfizer fell 86 cents, or 3.2 percent, to $26 as of 9:30 a.m. in New York Stock Exchange composite trading.
March 23, 2005 - Ivanhoe Newswire
Are you confused about what painkillers to take following recent arguing over the safety of COX-2 inhibitors? The American Heart Association's new science advisory on the use of COX-2 inhibitors and other non-steroidal anti-inflammatory drugs suggests using the drug with the fewest known side effects.
The authors of the advisory explain that COX-2 inhibitors were developed with the idea of having a good pain reliever that wouldn't upset the stomach. This sounded great until the long-term use of Vioxx (rofecoxib) was associated with increased heart attacks and strokes. Since the removal of Vioxx from the market, the FDA has conducted hearings into the safety of other COX-2 inhibitors.
The advice issued by the AHA includes:
"In terms of drug use, one rule is always best, and it holds whether you are treating cancer or treating a headache: Always use the safest medicine first," says Joel S. Bennett, M.D., a hematologist and a member of the writing group that drafted the advisory.
This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.
SOURCE: Circulation, published online March 21, 2005
February 18, 2005
MSNBC.com
Advisers to the Food and Drug Administration concluded Friday the popular painkiller Celebrex poses an increased risk for heart problems but should remain on the market because the benefits outweigh the dangers. In addition, the panel voted to allow the painkiller Bextra to stay on the market, although it noted that the drug also carries risks, NBC News reported.
The panelists suggested a number of possible restrictions for the drugs, including placing a “black box” warning on the label warning of the potential dangers and who’s at risk, providing more patient information, restricting which patients could get them and banning direct-to-consumer advertising.
The FDA is not bound to follow any of the recommendations. If it does decide to keep the drugs on the market, it then will determine what if any of the restrictions should be imposed.
The FDA’s arthritis and drug safety advisory committees, concluding three days of meetings to assess the risks of three popular painkillers called Cox-2 inhibitors, were to address Vioxx later in the day. All three drugs have been approved for sale by the government, though all have been linked to increased risk of heart attacks and strokes.
Meeting Chairman Alistair J.J. Wood of Vanderbilt University Medical School said it is important to find some way to help the public better understand the nature of risk. In the case of Celebrex, he estimated people who take it have a 1 percent higher risk of heart problems than people who don’t.
Panelists suggested the drug be limited to 200 milligrams for people who can’t take other painkillers for various reasons or who don’t respond well to other products. Heart trouble began to appear in colon polyp study patients who took Celebrex doses of at least 400 milligrams.
February 17, 2005
The Associated Press
A Merck & Co. official said Wednesday that all painkillers in the same class as the company's Vioxx could cause heart problems or strokes, a change from the drug-maker's earlier position that such health issues appeared limited to its drug.
Dr. Ned S. Braunstein, senior director of Merck Research Laboratories, told two panels of Food and Drug Administration advisers that since the company pulled Vioxx from the market last year, studies suggesting similar problems with Celebrex and Bextra have changed his mind.
"The data strongly suggest it is a class effect," for all drugs of that type, Braunstein said.
The drugs, designed to help people in chronic pain from conditions such as arthritis, are known as Cox-2 inhibitors. At least two other Cox-2 drugs are awaiting approval from the FDA, Arcoxia from Merck and Lumiracoxib from Novartis Pharmaceuticals.
The panels plan to discuss those drugs Thursday.
The two advisory committees are holding a joint three-day session to gather data on the safety of Cox-2 drugs and to make recommendations regarding their future use.
Recommendations could range from limiting these drugs to people not known to be at risk of heart problems, reducing the dose or duration of use, requiring tougher warning labels and even taking the drugs off the market.
Merck pulled Vioxx off the market Sept. 30 after a long-term study showed a higher rate of strokes and heart problems in people using the drug.
A panel of federal judges on Wednesday assigned all pending Vioxx product liability lawsuits against Merck to Judge Eldon E. Fallon in Louisiana, who is experienced in major pharmaceutical litigation.
There were preliminary indications of heart problems with the painkiller Vioxx before it was withdrawn, but it was difficult to sort through conflicting data, a health official said Wednesday at the opening of hearings on the risks of popular painkillers.
"We were not asleep at the wheel, we were actually engaged in reviewing a lot of data," Dr. Lourdes Villalba told a joint meeting of the FDA's arthritis advisory committee and its drug safety and risk management advisory committee, which are looking into Vioxx, Celebrex and Bextra.
CBS News Early Show Medical Correspondent Dr. Emily Senay reports the hearings are an attempt to answer why these drugs ended up on the market in the first place.
"How was it that risk factors for cardiovascular events like stroke and heart attacks, which were clearly there in some of the early studies, were not taken more seriously?" Senay asked. "These drugs were better than approved by the FDA, and yet, we're at the place in time when we're questioning whether or not they should be on the market."
Related drugs Celebrex and Bextra, made by Pfizer Inc., remain on the market, though some studies have also indicated they, too, may carry an added heart risk.
Villalba, medical officer responsible for Vioxx at the FDA's Center for Drug Evaluation and Research, pointed out that a study done in 2000 comparing Vioxx with the painkiller naproxen, showed a higher rate of heart problems with Vioxx, but other studies had conflicting results. In discussions with Merck officials, she said, the company suggested naproxen might have a heart protective effect.
Nonetheless, in 2002 the agency required an added warning on the Vioxx label urging caution in prescribing it for people with heart conditions.
"We never bought the naproxen theory," she said, and Merck officials said they no longer make that argument.
Pfizer vice president Dr. Joseph M. Feczko said the reports of increased heart problems need to be seen in context, considering that these drugs, known as Cox-2 inhibitors, bring an important benefit by reducing the sometimes serious stomach and intestinal problems that occur with many painkillers.
Dr. Kenneth M. Verberg, Pfizer vice president for inflammation and immunology, defended Celebrex as safe, though he said there is little data on use of the drug for more than one year. Further long-term testing of Celebrex is needed, he said.
Earlier, Dr. Ned S. Braunstein, senior director of Merck Research Laboratories, reported that the biggest increase in heart problems occurred after 18 months of use.
Earlier in the day, Dr. Garrett FitzGerald of the Department of Pharmacology at the University of Pennsylvania School of Medicine told the committees that, considering the hazard reports, similar new drugs may have to face tougher testing to win approval and those on the market ought to be put through the same new testing to retain approval.
FitzGerald told the panels that, just as low-dose aspirin affords heart protection and a small but definite risk of stomach and intestinal problems, so the Cox-2 inhibitors "afford gastrointestinal protection and a small but absolute risk of cardiovascular events."
CBS' Aleen Sirgany reports, FitzGerald said: "We're likely to subject new drugs in this class to hurdles before they're approved. Existing drugs should be subject to the same hurdles."
The two committees are holding a joint three-day session to gather data on the safety of the drugs and to make recommendations regarding their future use.
Recommendations could range from limiting these drugs to people not known to be at risk of heart problems, reducing the dose or duration of use, requiring tougher warning labels and even taking the drugs off the market.
As the session began, the FDA promised prompt action on recommendations from advisory committees.
Dr. Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, reminded the committees that the drugs in question are important painkillers widely used by people in chronic pain. It is important to balance the risks of drugs with their benefits, he said.
A drug that has a positive risk-benefit balance for the population as a whole, Galson added, may still cause serious problems for some individuals.
The FDA has been criticized for being slow to recognize problems with these drugs.
However, committee chairman Dr. Alistair J. Wood of Vanderbilt University stressed as he opened the session that the committee "is not here to delegate blame or revisit the past."
On Tuesday, the Health and Human Services Department announced that the FDA will establish a new Drug Safety Oversight Board to monitor medicines once they're on the market and will update physicians and patients with emerging information on risks and benefits.
The Health and Human Services Department announced Tuesday that the FDA will establish a new Drug Safety Oversight Board to monitor medicines once they're on the market and will update physicians and patients with emerging information on risks and benefits.
But as CBS News Correspondent Sharyl Attkisson reports, skepticism exists • even within the FDA • over whether such a drug review panel will work.
Attkisson spoke with FDA Dr. David Graham, who recently studied such drugs as Celebrex and Mobic, an alternative pain medication, with a doctor at Stanford University. Graham said his and other similar studies are not only not being encouraged by the FDA, but they are being withheld from the public.
Graham has been critical of the FDA before, alleging it repeatedly kept the public in the dark over potentially dangerous drugs. He said if the FDA worked in the public interest, it would encourage him to present his study.
"You would think that if the FDA were working for the public and were interested in drug safety that that would be their reaction," Graham told Attkisson.
February 16, 2005
The Associated Press
The Food and Drug Administration promised prompt action Wednesday on recommendations from advisory committees probing the safety of popular painkillers, but urged the advisers to balance the risks and benefits of the drugs.
Vioxx was pulled from the market Sept. 30 after a long-term clinical trial indicated some patients suffered heart attacks or strokes. Similar safety questions have risen concerning the related drugs Celebrex and Bextra.
The advisory committees are hearing from government officials, physicians, researchers and the public in three days of meetings before voting on recommendations for these prescription drugs, known as Cox-2 inhibitors.
Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the agency will act rapidly _ in the next few weeks _ on the committee recommendations. The FDA is not required to accept such recommendations, but generally does.
Galson reminded the group that the drugs in question are important painkillers widely used by people in chronic pain. It is important to balance the risks of drugs with their benefits, he said.
A drug that has a positive risk-benefit balance for the population as a whole, Galson added, may still cause serious problems for some individuals.
The FDA has been criticized for being slow to recognize problems with these drugs.
However, committee chairman Dr. Alistair J. Wood of
Vioxx was withdrawn by its manufacturer, Merck & Co. Celebrex and Bextra, made by Pfizer Inc., remain on the market.
The editor of a leading medical journal has questioned whether patients should continue using the drugs.
"Because there are well-established options for treatment of all the approved indications for these drugs, it is reasonable to ask whether the use of the drugs can now be justified," Dr. Jeffrey M. Drazen, editor of the New England Journal of Medicine, said in an editorial published online Tuesday.
In calling the advisory committee hearing Wednesday, the FDA's Center for Drug Evaluation and Research noted that many consumers and scientists have asked whether any Cox-2 drugs should be allowed to remain on sale.
The Health and Human Services Department announced Tuesday that the FDA will establish a new Drug Safety Oversight Board to monitor medicines once they're on the market and will update physicians and patients with emerging information on risks and benefits.
Dr. Mark Fendrick, an internal medicine specialist at the
"It comes down to the individual and his or her clinician to assess the risks and make the best informed choice," Fendrick said. "Until we know for sure about the cardiological safety of the Cox-2 inhibitors, I believe they should be limited to those individuals who have a risk of stomach injury and those who are at low risk for cardiac problems."
People who have a heart risk or who take aspirin to protect the heart should consider a traditional painkiller, he said.
Many people who take the Cox-2 drugs to avoid stomach problems also take aspirin to protect the heart, he noted, which cancels the gastrointestinal protection of the Cox-2 drugs.
The advisers will also be trying to determine what it is about these drugs that could cause an increase in heart problems.
On Monday, a paper in the journal Archives of Internal Medicine reported on a new analysis that indicates Cox-2 inhibitors raise blood pressure more than conventional pain medications.
A second possibility is that Vioxx directly affects endothelial cells, which line the heart and blood vessels.
A 1999 study of Alzheimer's patients taking Celebrex indicated the patients had four times the risk of heart problems. Pfizer contends that definitive conclusions cannot be drawn from that study. In December, a different study linked Celebrex to increased cardiovascular problems. The company said the results in that study were not consistent with a data the company had collected.
THE ASSOCIATED PRESS
OAKLAND, Calif. -- Kaiser Permanente, the nation's largest not-for-profit managed-care provider, has stopped prescribing Bextra until tests show whether the painkiller is safe.
The decision came amid "compelling" evidence of heightened heart risks associated with Bextra and a similar drug called Vioxx that manufacturer Merck & Co. pulled from the market in September, according to a company memo Kaiser issued late Friday.
Kaiser spokeswoman Beverly Hayon said the policy, which Kaiser is calling a moratorium, represents the first time the health system's doctors had decided to stop dispensing a drug that was approved by the Food and Drug Administration.
The Oakland-based HMO, hospital and clinic network, which serves 8.5 million patients in nine states and the District of Columbia, plans to stop filling new prescriptions for Bextra on Feb. 1 and on March 1 for refills.
Physicians will be notified with suggestions for alternative medicines they can prescribe. Bextra, made by Pfizer Inc., is most often recommended for arthritis patients.
"This is not a drug that saves lives," said Dr. Sharon Levine, who oversees medication usage for Kaiser Permanente's Northern California division. "It's a drug that provides a modest degree of pain relief - no better than Motrin - and the size of the risk, given the benefit provided, did not seem warranted."
The moratorium will last at least six months or "until the FDA and/or Pfizer can provide substantiated evidence to support the cardiovascular safety" of Bextra, the memo said.
The Kaiser doctors who reviewed Bextra's "safety profile" cited several studies that have raised concerns about whether the drug might increase the risk of heart attacks. They also noted that Bextra is in the same class of drugs as Vioxx, the painkiller Merck pulled from distribution after its own studies showed increased heart attack risks in elderly patients.
December 31, 2004
Bloomberg News
NEW YORK - Pfizer Inc. has asked U.S. regulators to approve the intravenous form of its Bextra painkiller, which in pill form has been linked to an increased risk of heart attacks in some patients.
The application for parecoxib was filed with the U.S. Food and Drug Administration in mid-December, Pfizer spokeswoman Susan Bro said Thursday. The FDA usually aims to complete its review of applications within 10 months.
Hank McKinnell, chief executive officer of New York-based Pfizer, is seeking approval for parecoxib as regulators prepare to weigh the safety of Cox-2 painkillers such as Bextra at a February hearing in Washington. Pfizer's other Cox-2 drug, Celebrex, was linked to heart risks in high doses in studies released this month, while Merck & Co. recalled Vioxx Sept. 30 for similar reasons.
"The FDA is going to be very carefully scrutinizing any new applications in the Cox-2 arena," said Steve Lampe, who helps manage $8 billion in assets at Delaware Investments in Philadelphia.
The FDA doesn't comment on applications under review. But last week, the agency urged doctors to limit prescriptions of Bextra and Celebrex before the February meeting. Bextra is one of five drugs that FDA reviewer David Graham identified as unsafe at a Nov. 18 Senate hearing.
Parecoxib, available in more than 45 countries, differs from the pill form of Bextra in that it is meant for short-term use and is given either intravenously or as a shot into a muscle after surgery. The company told investors at a Nov. 30 meeting that it planned to file the parecoxib application by the end of the year.
This month, Pfizer said it would warn doctors that Bextra is linked to an elevated risk of blood clots, heart attacks and strokes in cardiac-surgery patients. Bextra does not have U.S. approval for use during surgery.
In October, the company said studies of heart-bypass patient found an increase in cardiovascular complications among those who got either Bextra or a combination of Bextra and parecoxib compared with people who got opiates. Bextra caused no increase in heart attacks or stroke in arthritis patients, Pfizer said at the time.
December 27, 2004
Ivanhoe Medical Journal
A group of doctors want the medication valdecoxib (Bextra) removed from the market, except for extraordinary circumstances, because it increases the risk of stroke and heart attack. They pose their concern in a letter to the editor in the latest issue of the The New England Journal of Medicine.
Doctors from Vanderbilt University 's School of Medicine in Nashville, Tenn., referred specifically to rofecoxib, better known as Vioxx, saying that valdecoxib, another coxib medication, poses a similar health concern to the public.
The doctors cited two randomized, placebo-controlled clinical trials in patients immediately following coronary-artery bypass grafting. The trials revealed valdecoxib increased patients' risk for serious cardiovascular outcomes by about a factor of three.
While Pfizer, the manufacturer of Bextra, acknowledges the cardiotoxicity posed to patients at high risk for heart disease, the authors of the letter write, "The crucial public health question concerns the safety of patients who are taking lower doses of valdecoxib for musculoskeletal disorders, most of whom have a lower baseline of cardiovascular events."
The doctors note valdecoxib is used by 7 million patients worldwide, and they say not enough is known concerning the cardiovascular safety of the drug in populations at lower risk for heart disease.
SOURCE: The New England Journal of Medicine, 2004;391:2767
Reuters
WASHINGTON -- U.S. health regulators recommended on Thursday that doctors limit prescribing painkillers like Pfizer Inc.'s Celebrex and Bextra, in light of recent evidence that they may increase the risk of heart attack and stroke.
A Food and Drug Administration health advisory said officials were still weighing sometimes conflicting data, urged physicians to consider the recent information in weighing the benefits and risks for individual patients.
"The actions that we're recommending in the advisory are for more limited prescribing than would currently be included in the approved labeling for these products," John Jenkins, director of the FDA's Office of New Drugs, told reporters on a conference call.
Patients vulnerable to gastric bleeding associated with older painkillers may still be appropriate candidates for Cox-2 drugs that include Celebrex and Bextra, the FDA said.
A Pfizer representative was not immediately available to comment on the FDA advisory.
The FDA action follows a recent series of warnings of increased heart attacks and strokes connected to both over-the-counter and prescription painkillers.
Merck & Co. Inc. voluntarily withdrew its arthritis drug Vioxx in September after a study showed the painkiller doubled the chances of heart attacks and strokes.
Pfizer has kept arthritis medicine Celebrex on the market, but agreed this week to suspend consumer advertising. Pfizer has also placed a new note on its Bextra painkiller, warning of increased heart attacks and blood clots in patients who have just had heart bypass surgery.
Health officials warned on Monday of a risk of heart attack and stroke in over-the-counter naproxen, sold as a generic and as several brand names, including Bayer AG's Aleve, and as Roche AG's Naprosyn.
Vioxx, Celebrex and Bextra are in a newer class of painkillers known as COX-2 inhibitors, designed to avoid the gastric bleeding associated with older drugs like aspirin.
COX-2 inhibitors, in turn, are a subset of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which include aspirin, naproxen and ibuprofen.
December 19, 2004
Reuters
Lester Crawford, Acting Food and Drug Administration Commissioner, told the paper in an interview that the agency's review could result in the withdrawal of the entire range of drugs.
"We are looking at all the COX-2s and will make an announcement shortly," Crawford was quoted as saying by the FT. "All the regulatory options are open, including withdrawal. I have serious concerns about COX-2s as a class."
His comments came after
Celebrex is part of the same family of drugs as Merck & Co Inc.'s Vioxx, which the company pulled from the market on Sept. 30 because it raised the risk of heart attack and stroke.
Regulators could ask Pfizer to pull Celebrex from the market although Pfizer has said it would fight any attempt to withdraw the drug.
"We find no basis for withdrawal" of Celebrex, Hank McKinnell, Pfizer chief executive, told the FT.
Also on Friday, the National Institutes of Health halted a trial testing Celebrex for cancer prevention because the drug more than doubled heart-attack risk compared with placebo.
The NIH said it was reviewing all government grants for studying Celebrex and other COX-2 inhibitors.
Celebrex and other similar drugs were designed to relieve pain with a lower risk of life-threatening stomach bleeding than older, over-the-counter drugs.
Reuters
December 17, 2004
by Kim Dixon
CHICAGO (Reuters) - Doctors writing in a prominent medical journal on Friday recommended that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large study found the drugmaker's sister drug, Celebrex, doubled risk of heart attacks.
Both drugs are members of the so-called COX-2 inhibitor class of painkillers, which recently gained notoriety when Merck Inc. withdrew Vioxx in September after a study found it doubled the risk of heart attack and stroke.
A letter by doctors published in The New England Journal of Medicine's Dec. 23 edition said in light of Vioxx and negative signs on Bextra, Bextra should be avoided.
"To protect the safety of the public, we write to recommend that clinicians stop prescribing valdecoxib (Bextra), except in extraordinary circumstances," editorial writers at The New England Journal of Medicine wrote in an issue dated Dec. 23 but released early.
Earlier on Friday, Pfizer said a government-sponsored trial of Celebrex was halted after patients taking the medicine had more than twice as many heart attacks as patients taking a placebo.
Pfizer has aggressively defended Bextra and Celebrex since Vioxx's withdrawal and questions about safety arose. Officials at Pfizer said they had not seen the medical journal letter and could not comment.
Friday's developments will rekindle debate over the merits and safety of the entire class of painkiller drugs, doctors said.
The authors of The New England Journal of Medicine letter are doctors at the Vanderbilt University School of Medicine.
They said they made the recommendation in light of the long lag time between when evidence emerged on Vioxx and its withdrawal, coupled with two negative studies suggesting Bextra boosts heart problems in bypass patients by a factor of three.
The New York Times
December 10, 2004
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 treated with Bextra for pain were more likely to have heart and blood clotting problems than other patients who did not receive any drug."
The problems included heart attack, stroke and blood clots in the legs and the lungs, the F.D.A. said.
It said the new label would indicate that Bextra was not suggested for treatment of pain immediately after coronary bypass graft surgery.
Bextra is a type of painkiller known as a COX-2 inhibitor. The Merck arthritis drug Vioxx, also a COX-2 inhibitor, was withdrawn from the market because of findings that it increased the risk of heart attack and stroke.
These drugs have become widely prescribed in part because they are supposed to lower the rate of ulcers and gastrointestinal bleeding.
The F.D.A. is convening a panel in February to review all COX-2 inhibitors.
Shares of Pfizer fell 13 cents, to close at $27.37 on the New York Stock Exchange.
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