CELEBREX® Breaking News
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On December 20, 2004, the FDA mandated that Pfizer pull all Celebrex advertising from TV, radio, newspapers and magazines.
Clinic to Study Heart Risks From Drugs
CLEVELAND , Dec. 14 2005 (UPI) -- The Cleveland Clinic plans a 20,000 patient clinical trial to study the risks to the heart from arthritis drugs, following the withdrawal of Merck's Vioxx.
The four-year study, set to begin next year, will compare three painkillers commonly used by arthritis patients who have cardiovascular disease or who are at high risk of heart problems, the Wall Street Journal reported.
The drugs are Pfizer Inc.'s Celebrex, and prescription-strength doses of over-the-counter tablets ibuprofen and naproxen.
The Food and Drug Administration requires strong warning labels for a range of painkillers, saying consumers face increased cardiovascular risk.
The Cleveland study may answer critics who say some past studies weren't definitive.
"The public and the medical community are confused," said Steven E. Nissen, who will be the lead investigator of the new study. "The relative safety of these three drugs is simply not known. We're going to answer the question are they the same or are they not."
Copyright 2006 United Press International, Inc. All Rights Reserved
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Federal Lawsuit Says Drug Celebrex was Responsible for Woman's Death
The complaint was filed on behalf of an elementary school teacher from Tazewell County who died of a heart attack.
By Lindsey Nair
A federal lawsuit filed in Roanoke against the makers of the pain medication Celebrex claims the drug either caused or contributed to a Tazewell County woman's death in 2003.
The lawsuit joins a rising tide of such claims against the makers of Celebrex and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as Vioxx and Bextra.
Bryant Haskins, a spokesman for Pfizer Inc., the pharmaceutical company that manufactures Celebrex, said he had not seen the lawsuit and therefore could not comment specifically on it.
Margaret Sue White, a 54-year-old elementary school teacher from Raven, died Dec. 11, 2003, of a heart attack, the lawsuit states. She had been taking Celebrex to treat fibromyalgia, a musculoskeletal pain disorder.
The lawsuit was filed last week on behalf of James White, Margaret White's husband and the representative of her estate.
Along with the New York-based Pfizer, the lawsuit names as defendants G.D. Searle LLC and Pharmacia Corp. G.D. Searle, the developer of Celebrex, was acquired by Pharmacia, which was in turn acquired by Pfizer in an April 2003 merger.
The lawsuit claims that although scientific studies document that Celebrex more than triples the risk of heart attacks and strokes, the makers have refused to withdraw it from the market and Margaret White was unaware of the serious side effects.
Further, the document states, the makers of Celebrex should have known about these risks but advertised to the public that the drug was safe and effective.
As a result, the defendants are liable for Margaret White's death, her husband asserts.
He is seeking unspecified compensatory and punitive damages, as well as special damages to include medical expenses, funeral and burial costs, and pain and suffering.
James White is being represented by James F. Humphreys & Associates, a Washington, D.C.-based law firm that is handling several Celebrex lawsuits.
Thomas Urban II, the attorney representing White, said hundreds of Celebrex lawsuits have been filed across the country, so it may be a relatively new phenomenon compared to the thousands of lawsuits against the maker of Vioxx, Merck Inc.
Merck withdrew Vioxx from the market in September, after a study of high doses of the drug in cancer patients showed an increased risk of heart attack and stroke.
Bextra, another NSAID manufactured by Pfizer, was voluntarily withdrawn from the market in April after the Food and Drug Administration found that the risks from taking the drug outweighed the benefits.
Celebrex remains on the market, despite some concerns about the drug.
In February, Pfizer admitted the existence of a 1999 clinical trial that showed that Celebrex increased the risk of heart attack in elderly patients by almost four times that of a placebo.
In April, the FDA issued an alert stating that Celebrex, like other NSAIDs, has been linked to an increased risk of serious cardiovascular problems. The FDA requested that manufacturers of NSAIDs include that warning on the package insert.
But Pfizer continues to stand behind Celebrex.
"It is important to note that a massive amount of data, collected over a 10-year period from more than 40,000 patients, continues to support Celebrex as a critical therapeutic option for millions of people who depend on the medicine to help them live normal, active lives," said Haskins, the Pfizer spokesman.
Like the Vioxx cases, Celebrex lawsuits might be consolidated in one federal court district for discovery purposes, Urban said. Discovery is the uncovering of evidence and facts before a trial.
When so many similar cases are filed across the country, it often makes sense to consolidate for discovery so the same witnesses do not have to be interviewed by thousands of attorneys.
The Vioxx cases were consolidated in New Orleans but were moved to Houston after Hurricane Katrina, Urban said. Celebrex cases may be consolidated in California .
After discovery is complete, the cases are typically sent back to the district where they were originally filed to be heard.
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LFDA Safety Labeling Changes: Celebrex.
On July 29, the FDA approved safety labeling revisions for the nonsteroidal anti-inflammatory (NSAID) drug celecoxib (Celebrex capsules, made by Pfizer Global Pharmaceuticals) to warn of contraindications and warnings associated with this class of drugs and to emphasize the need to minimize its use to the lowest effective dose for the shortest possible duration.
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Safety of Painkillers Subject of Unprecedented Study
January 14, 2006:
The Cleveland Clinic is undertaking an unprecedented study of painkillers, seeking the latest word on their safety for high-risk patients — those with histories of heart attack, vascular disease, chronic chest pain, or stroke.
Drug manufacturer Pfizer will fund the independent, $100 million investigation into high-risk patients' use of its product Celebrex, the only COX-2 inhibitor still on the market, as well as two non- steroidal anti-inflammatory drugs: ibuprofen and naproxene. Internationally, about 20,000 people will receive one of the three drugs, plus one to prevent stomach irritation, so the true effect of the pain relievers can be measured, The Associated Press reports.
“We will have 10 times the statistical power of any trial ever done of these drugs,” said Steve Nissen, the Cleveland cardiologist who will lead the study.
Results are expected in four years, he said.
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Regular use of selective COX-2 inhibitors decreases risk of breast cancer
Regular use of selective COX-2 inhibitors significantly reduces the risk of breast cancer. A case-control study published today in the open access journal BMC Cancer observed that daily use of selective COX-2 inhibitors, including celecoxib (Celebrex) and rofecoxib (Vioxx), was associated with a 71% reduction in the risk of breast cancer. Non-selective COX-2 inhibitors, such as aspirin and ibuprofen, also reduced the risk of breast cancer. This study highlights the potential of nonsteroidal anti-inflammatory drugs (NSAIDs) for the prevention of breast cancer.
Randall Harris and colleagues from The Ohio State University College of Medicine and Public Health, Columbus, Ohio, USA, collected data on 323 patients with invasive breast cancer shortly after their diagnosis. Harris et al. matched the patients for age, race and county of residence with 649 control individuals with no personal history of cancer. Data collected for patients and controls included information on breast cancer risk factors, and the use of selective COX-2 inhibitors and other NSAIDs.
Harris et al.'s results show that selective COX-2 inhibitors, as a group, were associated with a significantly reduced risk of breast cancer (OR=0.29) when taken daily for at least two years: a daily dose of 200 mg celecoxib reduced the risk of breast cancer by 83% and a daily dose of 25 mg rofecoxib reduced the risk of breast cancer by 64%. Regular use of non-selective COX-2 inhibitors - aspirin (325 mg), ibuprofen (200mg) and naproxen (250 mg) – also significantly reduced the risk of breast cancer, but less so than regular intake of selective COX-2 inhibitors. Ibuprofen and aspirin significantly decreased the risk of developing breast cancer when taken at least every other day for at least five years. Regular intake of acetaminophen, an analgesic lacking COX-2 activity, had no effect on the risk of breast cancer.
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Safety of CELEBREX®, other Vioxx®-like drugs in question
October 7, 2004
Merck & Co.'s abrupt withdrawal of Vioxx® from the market has increased scrutiny on other COX-2 inhibitors - specifically CELEBREX®, made by Pfizer Inc. The European Medicines Agency in London recently stated that it would review safety data on all drugs of the class; the FDA has indicated previously it will be doing the same; and in the October 6, 2004, edition of the New England Journal of Medicine, two experts stated that many more people may be at risk from taking other popular drugs of the same class.
Merck withdrew its bestselling painkiller from the market after a placebo-controlled study found that the drug increased the risk of heart attack and stroke among users. Like Vioxx®, CELEBREX® is part of a group of prescription medicines called COX-2 inhibitors that are supposed to be safer for treating arthritis pain than over-the-counter remedies like aspirin, ibuprofen and naproxen.
European medicines regulators will review all available long-term studies of drugs in the COX-2 inhibitors class. In addition to celecoxib (CELEBREX®), the regulators will review studies of valdecoxib, marketed as Bextra®, and also made by Pfizer Inc. which is called Bextra®. Both are made by Pfizer Inc.
In the two New England Journal of Medicine articles, both scientists stated that research into the way COX-2 inhibitors work indicates that CELEBREX® and similar drugs could also cause negative cardiovascular events similar to those linked to Vioxx®, and that doctors should avoid prescribing them for patients at risk of heart disease. Two more COX-2 inhibitors, Arcoxia (from Merck) and Prexige (from Novartis), are awaiting FDA approval.
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Deaths reported from cox-2 inhibitors Vioxx® and CELEBREX® Side Effects
CELEBREX® and Vioxx® were approved for the U.S. market back in 1999 for the treatment of arthritis and other types of pain. Both of the drugs constituted a new class of drugs called Cox-2 inhibitors. Their release seemed to be cause for celebration for individuals who had previously taken aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs), but were bothered by gastrointestinal problems commonly associated with them.
CELEBREX® and Vioxx® were touted as great medical developments in the many ads that promoted their benefits. Principal among these was the claim that Vioxx® and CELEBREX® relieved pain without causing stomach problems. Specifically, these Cox-2 inhibitors are prescribed to relieve symptoms commonly associated with osteoarthritis, menstrual cramps, or other acute pain. Unfortunately, Vioxx® and CELEBREX® pose troubling effects for some users.
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