Kaiser Permanente Bans Use of Bextra

Could Celebrex be Next?

The controversial COX-2 drug Bextra has been banned by one of the nation's largest managed care organizations. In a move that is unprecedented, Bextra has become the first drug approved by the Food and Drug Administration to be banned by Kaiser Permanente.

Dr. Sharon Levine, associate executive director of the company's Northern California unit said that Kaiser physicians had already avoided using the drug. But "for safety and quality reasons, we don't want to be involved in dispensing this drug," she said.

Dr. David Campen, Kaiser's medical director of pharmacy services, said yesterday, Kaiser doctors will continue prescribing Celebrex. At low doses, "Celebrex does not appear to have the same risks as Bextra or Vioxx", Dr. Campen said.

"But clearly at the higher dose levels, there does seem to be a problem" with Celebrex, he said.

Both Celebrex and Bextra offer no unique benefits but plenty of possible risks. Clinical trials have found that Celebrex and Bextra cure pain no better than older medicines like ibuprofen and claims that they are safer on the stomach than older medicines have never been proven.

Related story: FDA Probes Celebrex and Bextra Safety

Warfarin and Celebrex Could be Deadly Combination

Research done at the University of Toronto suggests that elderly patients taking the blood thinning drug Warfarin are at increased risk of upper gastrointestinal (GI) hemorrhage if they are also taking the painkilling COX-2 drugs Celebrex or Bextra.

On Warfarin and Celebrex or Bextra?

Results of this study were published in the January 25/2005 edition of the JAMA's, Archives of Internal Medicine. The study examined 98,821 elderly patient and concluded that those "taking warfarin concomitantly with selective COX-2 inhibitors have an increased risk of hospitalization for upper GI hemorrhage. The risk appears similar to that of patients simultaneously taking warfarin and nonselective NSAIDs."

For more information: Celebrex Dangers

Related Article: Celebrex and Bextra Dangers

Consumer Group Calls on FDA to Recall Celebrex and Bextra

According to the consumer group Public Citizen, a petition has been filed with the FDA calling for the COX-2 drugs Celebrex and Bextra to be removed from the market.

A press release issued by Public Citizen states, “If a drug offers no unique benefit compared to other drugs for treating the same problem (in this case arthritis and pain) but subjects patients to a unique risk, it must be removed from the market.”

Ban the Sale of Celebrex and Bextra

“The Food and Drug Administration should immediately ban the sale of Celebrex and Bextra, which put millions of people, many of them elderly, at risk of heart attack,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “These drugs are not only more expensive and more dangerous than older, safer pain relievers, they are no better at protecting the gastrointestinal tract.”

"Public Citizen has a long history of identifying unsafe or ineffective drugs. Vioxx, for example, was the ninth prescription drug to be taken off the market in the past seven years that Public Citizen had previously warned consumers not to use. For four of the drugs – Vioxx, Baycol, Rezulin and Serzone – Public Citizen issued warnings more than two years before their removal from the market. Public Citizen warned patients not to use Celebrex three and half years before the government announced that a study showed increased heart risks."

Complete Press Release:Public Citizen Petitions FDA to Take Celebrex and Bextra Off the Market

Related Story: Celebrex and Vioxx Dangers

Celebrex and Vioxx Overprescribed?

A study by doctors at Stanford University and the University of Chicago found that Vioxx and Celebrex were taken by millions of people who were not at risk of gastrointestinal bleeding. Aspirin and some other lower-cost painkillers can cause gastrointestinal bleeding and this was the main reason patients were told to switch to the more expensive COX-2 drugs.

The study results show that 73 percent of patients considered at low or very low risk of gastrointestinal problems should not have been considered for the newer drugs.

"We found a rapid, nationwide shift away from older, inexpensive drugs with better established safety and efficacy to newer, costly drugs with no real history," said study author G. Caleb Alexander, a medical ethicist at the University of Chicago.

Vioxx and Celebrex Overprescribed

The study also showed that by 2002, 17.6 million patients at low risk of gastrointestinal bleeding, or 66 percent of those patients, were taking one of the two COX-2 inhibitors.

Also included in the study is the alarming statistic that the drugs were taken by as many as 16 million people suffering from congestive heart failure, or liver or kidney dysfunction. Patients that clearly should not have taken Vioxx or Celebrex and might also have been hurt by these drugs.

The question being asked now is, "Who is a fault here?" The FDA, for not regulating and testing thoroughly enough? Merck and Pfizer, for advertising unsafe products directly to the public? Doctors, who felt that newer was better? Perhaps all of the above . . .

Related article: Vioxx and Celebrex Dangers

More Evidence of Vioxx and Celebrex Dangers

Two new articles published in this week's issue of the American Heart Association journal, 'Circulation', show more evidence that the COX-2 class of drugs, (Celebrex, Vioxx and Bextra) increase the risk of heart disease.

The first study shows that Pfizer Inc.'s Bextra can triple the risk of heart attack and stroke in certain patients.

Dr. Garret FitzGerald of the University of Pennsylvania School of Medicine and colleagues used a statistical approach called meta-analysis to combine the findings of two trials to estimate the risk of heart attack and stroke in people taking Bextra, another COX-2 inhibitor made by Pfizer.

Their analysis, first presented at a Heart Association meeting last November suggests Bextra tripled the combined incidence of heart attack and stroke in heart bypass surgery patients.

NSAIDS work by suppressing two enzymes called COX-1 and COX-2. But they can cause gastrointestinal bleeding, and research had suggested that suppressing COX-1 caused this damage.

So drug companies worked to make drugs that only affect COX-2, the enzyme associated with pain and inflammation.

But in the second study, the researchers studied mice genetically prone to hardening of the arteries or atherosclerosis and found that a compound called thromboxane or TxA2, produced by COX-1, accelerates atherosclerosis.

"This is of particular interest, as low-dose aspirin prevents heart attack and stroke by blocking COX-1 formation of TxA2 in blood cells called platelets," FitzGerald said in a statement.

When a COX-2 inhibitor was added, something happened that may help explain why the COX-2 inhibitors raise the risk of a heart attack, said FitzGerald's colleague, Karine Egan.

"Addition of the COX-2 inhibitor caused changes that, if they occurred in humans, would result in a loss of stability of the plaque, making it more likely to rupture and activate clotting, causing heart attack or stroke," she said.

"These results would have disturbing implications for patients at high cardiovascular risk treated with aspirin and a coxib (COX-2 inhibitor)," FitzGerald said.

If Pfizer needs any further reason to recall Celebrex and Bextra perhaps they should read Dr. FitzGerald's conclusions, "The clear emergence of a cardiovascular hazard from COX-2 inhibitors in patients, the weak rationale for a study of their protective properties in the first instance, and now this evidence from mice would indicate to me that a trial in high-risk patients, such as that proposed for Celebrex is, at best, ill advised."

Related story: Celebrex and Vioxx Drug Information

European Medicines Agency to Probe Vioxx and Celebrex

In a move that parallels that of the FDA, The European Medicines Agency will probe into the safety of the COX-2 drugs Vioxx, Celebrex and Bextra. Officials from Pfizer Inc, Merck & Co Inc and Novartis AG will appear before a panel of European drug experts next week, (Novartis has a new COX-2 drug called Prexige which they have not sought approval for due to the Vioxx controversy).

The European drug agency's Committee for Medicinal Products for Human Use has the power to recommend withdrawal, suspension or extra warnings. The committee is now considering whether to revise its advice to EU countries on use of all COX-2 drugs but will not necessarily make any immediate recommendations after its Jan 17-20 meeting.

"We are calling the companies in to present data and answer questions," Martin Harvey, a spokesman for the London-based agency, said.

Vioxx has been pulled from the market and its maker Merck faces billions of dollars in class action claims. Celebrex and Bextra are still available but their maker, Pfizer Inc. has pulled all advertising. The FDA has announced that they will further investigate the COX-2 drugs February 16, 17 and 18, 2005 in Gaithersburg, Md.

FDA to Probe NSAID's (Celebrex and Bextra)

The FDA announced Friday that it will hold three days of hearings in February on the benefits and risks of the COX-2 family of drugs. This includes Pfizer Inc.'s Celebrex and Bextra arthritis medications.

Kathleen Quinn, a spokeswoman for the FDA, said regulators would allow the public to comment, either orally, in writing or with data. Public comments would be allowed during the first day of the hearing between 1 and 3 p.m., but time would be limited.

Pfizer (Celebrex and Betra) officials have been asked to make presentations during the three-day hearing and will participate. They say they welcome the opportunity to be heard but haven't determined which officials will be making presentations.

What follows is the press release from the FDA web site:

FDA Announces Dates for Public Meeting on Non-Steroidal Anti-Inflammatory Drugs

The Food and Drug Administration (FDA) has announced a joint public meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to be held February 16, 17 and 18, 2005.

The committees will discuss the overall benefit-to-risk considerations (including cardiovascular and gastrointestinal concerns) for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines.

Members of the public are encouraged to participate in this meeting. Interested persons may present data, information or views, orally or in writing, on issues pending before the committees. Oral presentations from the public will be scheduled between 1:00 p.m. and 3:00 p.m. on February 17. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should register to speak at the meeting before February 4, 2005. No registration is required for those only planning on attending the meeting.

The three-day meeting will be held at the Hilton Washington DC North, 620 Perry Parkway, Gaithersburg, Md. The proceedings will start at 8:00 a.m. each day. Agendas and other background materials will be posted online no later than one business day before the meeting.

For more information regarding this meeting, including contact information for members of the public interested in making presentations or submitting written comments please go to: http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html.

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Doctors Not Prescribing Celebrex

After the recall of Vioxx, sales of competitor, Celebrex climbed sharply as doctors and patients looked for an alternative. However, that Celebrex sales increase was short lived due to the release of test results that showed Celebrex caused heart complications similar to Vioxx. Now many doctors and patients are again seeking an alternative pain killer.

Patients are clearly concerned for their health. On one hand they seek relief from the pain and on the other hand they must be concerned about heart complications that may be caused from taking COX-2 drugs such as Celebrex and Bextra.

"Celebrex Risk Too Great"

Doctors are also concerned about their patients' health and also must be aware of liability risks associated with prescribing these COX-2 class drugs.

Commenting on the Celebrex situation, Dr. Michael Halperin, a surgeon with the Norwich Orthopedic Group said, “I'm not saying Celebrex should never be prescribed, But legally, for me, it's a risk I don't need to take, especially when there are plenty of other medications out there that are equally effective.”

Due to the lack of definitive information from Pfizer Inc. and the FDA many doctors are taking a conservative approach and as a result some analysts are predicting that sales of Celebrex and Bextra will drop by as much as fifty percent.

Related article: Celebrex Side Effects

Vioxx and Celebrex Lawsuits Top Health Stories in 2004

COX-2 inhibitors, painkillers Vioxx and Celebrex came under fire in 2004. Vioxx was recalled from the market amid claims that its continued use would result in heart complications. Hundreds of Vioxx lawsuits have been filed as a result. Merck, the makers of Vioxx have stated that they will defend against all Vioxx class action lawsuits.

Celebrex, another of the COX-2 type drugs has also (along with Bextra) been identified as causing the same type of heart problems as Vioxx. The makers of Celebrex, Pfizer Inc. has suspended all Celebrex advertising, but has not recalled the product. Pfizer executives site the many years of safe use of Celebrex and insist that using Celebrex is not unsafe. Like Merck (makers of Vioxx) Pfizer executives have stated that they will fight any Celebrex related lawsuits.

2004 has ended with many pain sufferers looking for alternatives to Vioxx and Celebrex. Questions are being asked about the effectiveness of the FDA and it's handling of the Vioxx, Celebrex and Bextra situations. Hundreds of Vioxx lawsuits and at this writing, at least two Celebrex class action lawsuits have been filed - but above all else, people want answers.

What will 2005 bring? It's anyones guess, but the Vioxx and Celebrex stories aren't over yet.

For more information: Celebrex Lawsuits