Celebrex May Prevent Cancer but Raises Heart Risks
Apr 3, 2006 — CHICAGO (Reuters) - Celebrex, a treatment for arthritis, may help prevent colon cancer in high-risk patients, but it also raises the risk of heart attack and stroke, researchers said on Monday.
Pfizer Inc. said sustained, higher doses of Celebrex can reduce pre-cancerous polyps by as much as 45 percent, based on the drug's overall performance in two clinical trials.
However, a broad analysis of both studies found patients taking Celebrex had more cardiovascular events, contradicting a preliminary analysis of one of the studies.
Celebrex, a so-called COX-2 inhibitor, belongs to the same class of drugs as Merck & Co. Inc.'s Vioxx, which Merck pulled from the market in 2004 after a study showed it doubled the risk of heart attack and stroke.
The studies, presented on Monday at the 97th Annual Meeting of the American Association for Cancer Research, evaluated whether the over-expression of the COX-2 enzyme is related to the growth and spread of colorectal tumors.
COX-2 inhibitors may reduce the occurrence of the precursor, colorectal adenomas (benign tumors), in patients with a family history of the disease, as well as the development of sporadic colorectal tumors.
Both trials enrolled patients who had already had precancerous colon polyps removed. They were about 60 years old, on average, at the start of the trial; most had cardiovascular risk factors such as high blood pressure, diabetes, chest pain, previous heart attacks, strokes or were smokers.
One study, the APC trial, was co-sponsored by the National Cancer Institute and Pfizer. The other, the PreSAP trial, was sponsored by Pfizer.
Final results of the APC trial confirmed preliminary results from the study released in late 2004 showing a statistically significant increase in the risk of serious cardiovascular events in the Celebrex group compared to patients taking a dummy pill.
Pfizer said preliminary results of the PreSAP trial did not show an increase of cardiovascular events. But Pfizer said a new, broader analysis of cardiovascular events, including chest pain, found more cardiovascular events with Celebrex compared to placebo.
Pfizer said the results are consistent with the current warnings on cardiovascular risk in the Celebrex label.
The drugmaker said it has provided available information about the APC and PreSAP trials to regulatory agencies around the world. Pfizer said it will submit final study reports to the U.S. Food and Drug Administration and other regulatory agencies.
A Floral Park man suied Pfizer, claiming the pharmaceutical manufacturer's anti-inflammatory drug Celebrex caused him to suffer an irregular heartbeat. The Celebrex lawsuit,filed in Nassau Supreme Court by Robert Roesler, 61, a disabled carpenter, comes in the wake of health warnings that the arthritis drug Vioxx causes heart problems.
Merck Says Vioxx Risks May Apply to Whole Drug Class
Feb. 16 (Bloomberg) -- Merck & Co. told U.S. Food and Drug Administration advisers today that research linking its withdrawn Vioxx to heart attacks and strokes may apply to the entire class of painkillers known as Cox-2 inhibitors.
Merck's testimony came on the first day of a three-day hearing in Gaithersburg, Maryland in which FDA advisers are examining whether the risks of Cox-2 drugs such as Pfizer Inc.'s Celebrex and Bextra outweigh their benefits. The panel will make a recommendation at the end of the hearing that could range from calling for the drugs' withdrawal to stronger safety warnings.
``We believe the data strongly suggest a class effect from Cox-2 inhibitors,'' said Ned Braunstein, senior director of Merck's research labs, whose voice grew hoarse during his testimony before a standing-room-only crowd. ``We would argue that long-term studies are needed'' to determine class effects.
Pfizer, also scheduled to testify today, has argued its drugs don't carry the same risks as Vioxx. At stake is the more than $4 billion in sales New York-based Pfizer generated from Celebrex and Bextra, part of a class of drugs once thought to be more effective than anti-inflammatory medicines such as aspirin and ibuprofen and easier on the stomach.
Pfizer excluded outside Celebrex data
By Carla Mozee, (see MarketWatch for full article)
Last Update: 4:40 PM ET Feb. 5, 2005
SAN FRANCISCO (MarketWatch) - A Pfizer official said analysis of its arthritis and pain drug Celebrex that the company submitted to federal officials did not include studies by independent researchers or other drugmakers indicating that Celebrex raised the risk of heart problems, the New York Times reported Saturday.
The Times said Dr. Joseph Feczko, Pfizer's president for worldwide development, said in an interview that a few studies conducted by outside parties found increased heart risks for patients taking Celebrex and Bextra.
A Pfizer-sponsored trial of Alzheimer's patients in 1999 found the increased risk. Pfizer never published the results of the trial, said the Times.
It also said the National Institutes of Health ended a study two months ago after discovering high doses of Celebrex more than tripled the incidence of heart attacks and strokes.
Feczko said of the two trials, "they are what they are," according to the Times. But "the overwhelming preponderance of evidence" indicates Celebrex and Bextra are safe, Feczko told the Times.
Feczko told the Times that Pfizer had conducted much less research on Bextra than on Celebrex because it felt Bextra was similar to Celebrex.
COX-2 is a class of non-steroidal anti-inflammatory drugs used primarily to treat chronic pain from osteoarthritis and rheumatoid arthritis.
Cox-2 & NSAIDs Lawsuits & Problems
Within weeks two major categories of painkillers linked to side effects
Vioxx was taken off the market after Merck & Co. discovered it doubled the risk of heart attack and stroke. When patients taking Vioxx made the switch to similar competitor Celebrex, within weeks Pfizer Inc. announced a study showed the drug also increased the risk of heart problems that appeared more significant than Vioxx. Days later, the National Institutes of Health said it found a similar, though smaller, risk with Aleve (generic name naproxen).
Concerned and confused patients are swamping doctors' offices with questions, but many doctors do not even know what to say. NSAIDs, or nonsteroidal anti-inflammatory drugs, are the most widely used class of drugs that includes aspirin, ibuprofen, naproxen and other drugs. For years, NSAIDs have been used for various ailments, but the drugs carry the risk of inducing serious stomach and intestine bleeding. About 20 percent of people that want pain relief cannot take NSAIDs because of the bleeding risks.
Cox-2 inhibitors include now recalled Vioxx, Celebrex and Bextra and were introduced in the late 1990s as an alternative to NSAIDs. The Cox-2 drugs were supposed to provide pain relief without the risk of bleeding problems, and the drugs quickly became popular even though some studies did show the drugs did not always prevent bleeding in the stomach or intestines.
Patients that are more at risk for heart trouble because of age or medical history are being advised against Cox-2 drugs and to take NSAIDs only when the pain gets really bad. A major study published in the Archives of Internal Medicine showed abruptly halting the use of naproxen and other NSAIDs increased the risk of having a heart attack within the next 30 days by 50 percent - especially in patients with rheumatoid arthritis or lupus.
NSAIDs are the most widely used drugs taken by tens of millions of people. Some experts believe that while the links to serious cardiovascular events is discouraging for some groups of people, there is a plus side. A great number of people take NSAIDs on a casual basis but may not even really need NSAID therapy.
Celebrex Heart Scare Hit Pfizer
Heart scares hit Pfizer's sales
By Dominic Walsh
PFIZER, the drugs group best known for producing Viagra, has suffered a collapse in US sales of its blockbuster Celebrex painkiller on the back of clinical trials showing a heightened risk of heart attacks.
Sales of Celebrex, an antiinflammatory used by 600,000 people in Britain, almost halved last week in the US, the world’s biggest drugs market, after the National Cancer Institute suspended its use in a long-term study.
The sharp fall in sales, news of which sent shares in Pfizer more than 1 per cent lower in early trading in New York before a recovery, is just the latest setback to hit the class of anti-inflammatory drugs called Cox-2 inhibitors, of which Celebrex is a market leader.
In September rival pharmaceuticals giant Merck withdrew its popular Vioxx painkiller after a trial showed an increased risk of heart problems and strokes. Many of the 400,000 British users of Vioxx subsequently switched to Celebrex.
The suspension of Celebrex dosing was made in the Adenoma Prevention with Celecoxib (APC) trial, in which patients taking between 400mg and 800mg of the drug daily were found to be 2.5 times more likely to experience “a major fatal or non-fatal cardiovascular event”.
Pfizer said that the findings were “statistically significant”, although it pointed out that a separate long-term cancer study — the Prevention of Spontaneous Adenomatopus Polyps trial — involving a daily dose of 400mg had revealed no such risk for users.
The company also revealed last week that an Alzheimer’s Disease prevention study conducted by the National Institutes of Health had shown no increased heart risk in elderly patients taking 400mg a day.
Despite the conflicting evidence, the public reaction has been swift and painful for Pfizer. Data covering about 55 per cent of prescriptions dispensed by US pharmacies found that Celebrex’s share of new prescriptions for arthritis drugs had dropped from 14.9 per cent to 7.9 per cent.
This data from Verispan mirrored data from ImpactRx, another drugs market research firm, which found that Celebrex’s share of new prescriptions for painkillers had fallen to just 3 per cent, down from 20 per cent at the start of October.
In contrast to Merck, Pfizer has so far refrained from withdrawing Celebrex from pharmacy cabinets. Just before Christmas, Hank McKinnell, chairman and chief executive of Pfizer, called for a full evaluation of both prescription and over-the-counter drugs by the US Food and Drug Administration and other regulatory bodies.
“Because the early information from these trials is inconsistent, physicians and patients are understandably confused,” said Mr McKinnell. “That’s why the full study results must be shared with the medical, scientific and regulatory experts.”
Pfizer said that Celebrex should remain a treatment option for arthritis and acute pain, adding: “According to good medical practice, it should be administered at the lowest effective dose for appropriate patients.”
FDA: Don't overdo pain pills
By Rita Rubin, USA TODAY
Just because you can buy a pain reliever along with your morning coffee and doughnut at the local convenience store doesn't necessarily mean it's safe to pop the pills for weeks on end.
Time release: Pain relievers shouldn't be taken longer than 10 days, according to the FDA.
By Tim Sloan, AFP
That's the message the Food and Drug Administration is trying to get out to consumers. If you think you need to take naproxen, ibuprofen or aspirin — all nonsteroidal anti-inflammatory drugs, or NSAIDs — for longer than 10 days, do so under a doctor's supervision, the agency is now advising. And don't take any more pills a day than the label, or your doctor, recommends.
If your doctor has prescribed Celebrex or Bextra, two newer NSAIDs known as COX-2 inhibitors, you and your doctor should discuss whether you really need to take the drugs, according to a just-released health advisory from the FDA.
If you're at risk for a heart attack or stroke but not for digestive tract bleeding, you probably should stick with an older NSAID. Theoretically, the COX-2 inhibitors are less likely to cause digestive tract bleeding, but Pfizer, maker of Celebrex and Bextra, has not yet been able to convince the FDA that it should be able to make that claim on the drugs' labels.
In recent weeks, studies comparing Celebrex, Bextra, Vioxx and naproxen — an older NSAID sold over-the-counter as Aleve — with a placebo have shown that they could increase the risk of heart attack and stroke, especially if taken for long periods or by people who are at high risk for such problems. Merck pulled its COX-2 inhibitor, Vioxx, off the market Sept. 30, but Celebrex and Bextra remain.
In light of the new information about risks of heart attack and stroke, Jenkins said, the FDA is requiring that researchers re-evaluate all prevention studies — in which healthy people are given a drug to see whether it prevents a disease or condition — involving Celebrex or Bextra.
Pfizer, maker of Celebrex and Bextra, says a planned FDA advisory committee meeting on COX-2 inhibitors in February "is the appropriate forum for a thorough review of all available data."
Meanwhile, the company said Friday in a statement that "patients should continue to consult their doctor to ensure they get the pain treatment appropriate for their individual medical need."
see full article at USAToday.com
Little Rock Law Firm Sues Pfizer Over Celebrex, Bextra
This drug lawsuit is on behalf of the stockholders:
12/22/04 11:58:41 AM
By Arkansas Business staff, Arkansasbusiness.com Daily Report
Emerson Poynter LLP, a law firm with offices in Little Rock, Houston and Seattle, said Tuesday that it filed a lawsuit against pharmaceutical giant Pfizer Inc., saying the company misrepresented facts about the safety of two drugs, Celebrex and Bextra.
Pfizer removed all marketing for Celebrex on Monday after questions were raised about the pain medication’s safety. Emerson Poynter’s lawsuit is the third Pfizer faces after disclosing Friday that Celebrex and Bextra might increase the chances of heart problems in users.
Last week, Pfizer released a study that Celebrex users had double the chance of experiencing heart problems than patients taking placebo.
Emerson Poynter filed the lawsuit on behalf of shareholders who purchased Pfizer stock between Nov. 1, 2000, and Dec. 16, 2004.
Emerson Poynter, whose Little Rock offices are at 2228 Cottondale Ave., was founded by partners John G. Emerson and Scott E. Poynter, both Arkansas natives. The firm specializes in securities purchaser class action lawsuits
Review Ordered of Studies Using Celebrex, Bextra
WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news - web sites) on Thursday ordered the review of preventative studies involving Pfizer Inc.'s painkillers Celebrex and Bextra, in light of recent evidence they may increase the risk of heart attack and stroke.
The FDA (news - web sites) also said doctors and consumers should weigh individual benefits and risks when taking painkillers, saying patients vulnerable to gastric bleeding may be appropriate candidates for Cox-2 drugs, that include Celebrex and Bextra
Vioxx Lawsuit Seen as Stronger than Celebrex Lawsuit
Most attorneys agree that lawsuits against Merck over Vioxx are "much stronger" than the expected cases against Pfizer over Celebrex, but additional negative information on Celebrex "would translate into a much greater liability problem," the Journal reports. In the event that FDA does not remove Celebrex from the market, Pfizer likely would face limited liability because "a drug still approved for sale on the market makes it much more difficult to prove in a court of law that it is unsafe," the Journal reports.
According to the Journal, Pfizer disclosing all information about the safety risks of Celebrex and allowing physicians and patients to decide whether to continue to prescribe and take the medication, "could save Celebrex" and provide a "helpful defense to the company." However, physicians and patients "don't always follow directions," and such a move also could "be construed as some admission of guilt," the Journal reports.
A Pfizer spokesperson said, "Product liability concerns don't dictate our decision making. Rather, it's the health and well-being of patients along with the guidance that we receive from the FDA that inform our decisions." Joseph Capobianco, a partner with Reisman Peirez & Reisman, said, "From a liability and lawsuit view, my advice would be to pull the drug off the market. That's the safest course." Paul Rheingold, an attorney who plans to file Celebrex lawsuits, said that the decision by Pfizer to suspend DTC ads for Celebrex indicates the company is "admitting something."