Manufacturer: Pfizer
Generic name:
Valdecoxib is a prescription drug used in the treatment
of osteoarthritis, rheumatoid arthritis, and painful menstruation
and menstrual symptoms. It is classified as a nonsteroidal anti-inflammatory
drug, or NSAID, and should not be taken by anyone allergic to these
types of medications.
Valdecoxib was manufactured and marketed under the brand name Bextra® by
G. D. Searle & Company. It was available by prescription in tablet
form until 2005, when it was removed from the market due to concerns
about possible increased risk of heart attack and stroke.
|
FDA
NSAIDs Decision Memo
SUBJECT: Analysis and recommendations for Agency
action regarding non-steroidal anti-inflammatory drugs and cardiovascular
risk
Executive Summary
Following a thorough review of the available data we
have reached the following conclusions regarding currently approved
COX-2 selective and non-selective non-steroidal anti-inflammatory
drugs (NSAIDs)1 and the risk of adverse cardiovascular (CV) events:2
• The three approved COX-2 selective NSAIDs (i.e., celecoxib, rofecoxib,
and valdecoxib) are associated with an increased risk of serious adverse
CV events compared to placebo. The available data do not permit a rank
ordering of these drugs with regard to CV risk.
• Data from large long-term controlled clinical trials that have included
a comparison of COX-2 selective and non-selective NSAIDs do not clearly
demonstrate that the COX-2 selective agents confer a greater risk of
serious adverse CV events than non-selective NSAIDs.
|
|
Severe
allergic skin reactions |
To
the Editor:
Since the 1960s, when the nonsteroidal anti-inflammatory drugs (NSAIDs)
were launched into the market, several adverse events have been reported,1
including skin eruptions mostly caused by nonimmunological rather than
allergic mechanisms.2,3 NSAIDs exert their analgesic, antipyretic, anti-inflammatory,
and antithrombotic effects by inhibiting both COX-1 and COX-2 activities.4-6
However, the primary responsibility for the synthesis of prostanoids
involved in acute and chronic inflammatory states has been credited to
COX-2, whereas the gastrointestinal adverse effects have been attributed
to COX- 1 activity.1,6 The consequent hypothesis that specific inhibition
of this enzyme could have therapeutic effects similar to those of other
NSAIDs but without causing gastrointestinal side effects led to the development
of COX-2–selective antagonists. Valdecoxib (Bextra, Pfizer, Buckinghamshire,
United Kingdom) is one of these new drugs. In the last few years, it
has been increasingly prescribed for the treatment of osteoarthritis,
rheumatoid
arthritis, primary dysmenorrhea, and moderate to severe postoperative
pain.7
COX-2–specific inhibitors ...
|
The
FDA, Vioxx, and crimes against humanity
|
What
about the risks of the drugs? Well, it's very clear that the FDA
takes no risk in allowing these drugs to be used. The pharmaceutical
companies take no risk in allowing them to be used. The only people
taking the risks are the patients themselves. The patients are the
ones suffering the heart attacks, strokes and the acceleration of
heart disease from consuming these drugs. It's the patients who have
to pay for all of the medical care associated with the detrimental
health effects of these drugs. It's the patients who lose quality
of life or have their lives prematurely ended because they've been
taking Cox-2 inhibitors. So all of the risks we're talking about
fall on the shoulders of the patients, while all of the benefits
are enjoyed by the pharmaceutical companies.
|
| |
Stevens Johnson Syndrome
Complete and submit the following information. Fields with (*) are required.
If you prefer, you may contact us at: (817) 334-0762 or toll free at (800) 803-3784.
This information will be kept private and confidential and used for the sole purpose of evaluating your case.
Please note that without a phone number or e-mail address, we will not be able to contact you.
You will be contacted by an attorney or paralegal, who is experienced in the area of drug injury law.
|
|
These are letters from the FDA issuing warnings and safety alerts for consumers about possible adverse reactions from taking the drug Bextra. This information is a good source to help you understand Bextra and Bextra side effects. FDA Talk Paper
T04-61
December 23, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors
Agency Requires Evaluation of Prevention Studies Involving Cox-2 Selective Agents
The Food and Drug Administration (FDA) today issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. The public health advisory is an interim measure, pending further review of data that continue to be collected.
In addition, FDA today announced that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents Celebrex (celecoxib) and Bextra (valdecoxib) to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition (such as colon polyps or Alzheimer's disease).
FDA is issuing an advisory because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery).
Also, as FDA announced earlier this week, preliminary results from a long-term clinical trial (up to three years) suggest that long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn and other trade name and generic products), may be associated with an increased cardiovascular (CV) risk compared to placebo.
Although the results of these studies are preliminary and conflict with other data from studies of the same drugs, FDA is making the following interim recommendations:
Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib), should consider this emerging information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal (GI) bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for Cox-2 selective agents.
Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account for each prescribing situation.
Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions. If use of an (OTC) NSAID is needed for longer than ten days, a physician should be consulted.
Non-selective NSAIDs are widely used in both over-the-counter (OTC) and prescription settings. As prescription drugs, many are approved for short-term use in the treatment of pain and primary dysmenorrhea (menstrual discomfort), and for longer-term use to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis. FDA has previously posted extensive NSAID medication information at http://www.fda.gov/cder/drug/analgesics/default.htm.
FDA is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005, which will provide for a full public discussion of these issues.
FDA urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.
The Public Health Advisory is available online at www.fda.gov/cder/drug/advisory/nsaids.htm.
| Kaiser bans painkiller Bextra | Kaiser Permanente has banned the distribution of Bextra, a painkiller made by Pfizer Inc. that is widely prescribed for arthritis and could possibly increase the risk of heart attack or stroke.
It is the first time the nation's largest HMO has refused to dispense a drug approved by the Food and Drug Administration.
Kaiser started the ban last week in its pharmacies after several specialists agreed that Bextra should no longer be prescribed and that existing patients using the drug should use alternatives, officials said.
|
|
Public Citizen Petitions FDA to Take Celebrex and Bextra Off the Market | WASHINGTON, Jan. 24, 2005. – Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately remove two widely prescribed pain relievers, Celebrex and Bextra, from the market because they increase the risk of heart attacks in patients. The group also urged the FDA to cancel plans to approve two other drugs in the same class.
Celebrex (known generically as celecoxib) and Bextra (valdecoxib) are among the vaunted class of drugs called COX-2 inhibitors, which are touted as anti-inflammatory agents that cause less gastrointestinal damage than older, standby pain relievers like aspirin or ibuprofen. However, not only are their gastrointestinal benefits insignificant, they elevate the risk of heart attack, Public Citizen’s petition says. In 2004, more than 23.9 million prescriptions were filled in the United States for Celebrex; 12.9 million for Bextra.
“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,” says the 12-page petition
|
|
Health News Article | Reuters.com Group Calls on FDA to Pull Pfizer Pain Drugs | WASHINGTON (Reuters) - U.S. regulators should pull Pfizer Inc.'s arthritis drugs Celebrex and Bextra from the market because they are too risky, U.S. consumer watchdog group Public Citizen said in a letter on Monday.
In a formal petition to the U.S. Food and Drug Administration, Public Citizen said the two drugs' potential to cause heart attacks and strokes outweighed any possible benefit.
The letter, a copy of which was obtained by Reuters, is the latest action following a series of warnings over heart problems connected to both prescription and over-the-counter painkillers.
Merck Inc. pulled its arthritis drug, Vioxx, from the market in September after a study showed its doubled the risk of heart attack and stroke. Last month, the National Institutes of Health halted two studies involving Celebrex and naproxen, a nonprescription painkiller sold as a generic and under several brand names, including Bayer AG's Aleve and Roche its letter sent Monday, Public Citizen said Pfizer's drugs have not been proven any safer than older non-steroidal, anti-inflammatory painkillers, known as NSAIDs, like aspirin or naproxen. NSAIDs are known to cause ulcers and other gastrointestinal problems that can sometimes lead to death.
|
|
Penn researchers add more evidence to demonstrate role of COX inhibitors in heart-disease risk | Febr In two articles, published in Circulation, researchers from the University of Pennsylvania School of Medicine provide further evidence for the role of cyclooxygenases (COX) in heart-disease risk. In one, a statistical meta-analysis of two placebo-controlled trials, the COX-2 inhibitor Bextra elevated the combined incidence of heart attack and stroke three-fold in coronary artery bypass graft (CABG) surgery patients. In the second, the investigators found that a fat produced by COX-1 speeds hardening of the arteries in a mouse model of atherosclerosis, which may have implications for low-dose aspirin therapy in heart patients.
|
|
FDA Sends Pfizer Inc. Letter Regarding Celebrex and Bextra Advertisements | The Food and Drug Administration today posted a letter on its website sent to Pfizer Inc. on Jan. 10, 2005 regarding various advertisements regarding Celebrex and Bextra. The letter is below.
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed:
1) a 15-second direct-to-consumer (DTC) television advertisement for Celebrex® (celecoxib) Tablets entitled “With Celebrex, Guitar” (ID# CL151775A) (guitar TV ad);
2) a 30-second television DTC advertisement entitled “Celebrex Presents, Arthritis Tips” (arthritis tips TV ad);
3) a print advertisement directed to healthcare providers for Celebrex entitled “Strength They Can Stay With” (ID# CL170002B) (Celebrex print ad);
4) a direct mail patient brochure for Bextra® (valdecoxib) (VA142934A) (Bextra direct mail brochure); and
5) a 27-minute long format DTC television advertisement entitled “On The Road to Joint Pain Relief” (ID# VA167865A) (infomercial).
|
|
F.D.A. Warns Pfizer About 2 Drugs' Ads | Febr The Food and Drug Administration has warned Pfizer Inc. that television and print advertisements for its painkillers Celebrex and Bextra misled consumers, according to a letter made public Wednesday.
Five advertisements did not disclose side effects and other risk information and made "unsubstantiated effectiveness claims," the F.D.A. said in a letter dated Jan. 10 that was posted on its Web site.
|
|
FDA to review licenses to Vioxx, Celebrex, Aleve and Bextra | The drugs Vioxx, Celebrex, Aleve and Bextra are aggressively advertised as pain relievers for arthritis patients. However, a recent study has hinted that these popular drugs were responsible for increased cardiovascular problems.
Painkillers or pain suppressors are actually inhibitors of the inflammatory chemical Cox-2. Clinical study pinpointed Vioxx and Celebrex, are linked to increased heart troubles. The third, Bextra, has also been associated with increased heart risks.
|
|
FDA urges limits on Celebrex, Bextra - Dec 23, 2004 | Febr The Food and Drug Administration issued a public health advisory Thursday, recommending doctors limit the use of Pfizer Inc.'s Celebrex and Bextra to patients who can't take other pain medicines.
Last week, Pfizer announced a clinical trial indicates arthritis painkiller Celebrex could carry an increased risk of heart attacks and strokes. In September, Merck & Co. Inc. pulled its pain reliever Vioxx from the market for similar reasons. Pfizer hasn't pulled Celebrex.
|
|
Putting out a warning on a stealthy reaction | The FDA has just changed the warning label on the pain reliever Bextra to emphasize the risk of a rare but potentially fatal "skin reaction," Stevens-Johnson syndrome.
Calling Stevens-Johnson syndrome a "skin reaction" is like talking about headaches when you really mean a brain tumor.
|
|
FDA ORDERS REVIEWS OF CELEBREX, BEXTRA STUDIES; ISSUES PUBLIC HEALTH ADVISORY | The Food and Drug Administration issued a statement Thursday requiring the evaluation of all preventative studies involving Pfizer Inc.’s COX-2 selective agents Celebrex (celecoxib) and Bextra (valdecoxib) in light of recent news that the painkillers have been linked to an increased risk of cardiovascular events.
The FDA also issued a public health advisory on the use of all non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 selective agents, until further data can be reviewed.
|
|
U.S. Urges Limiting Use of Pfizer's Celebrex, Bextra | WASHINGTON (Reuters) - 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.
|
|
EMEA Statement On Valdecoxib (Bextra/Valdyn) | Cardiovascular Risks In Coronary Artery Bypass Graft (Cabg) Surgery And Serious Adverse Skin Reactions -
The European Medicines Agency (EMEA) and its Scientific Committee for human medicines have been made aware of new safety information on cardiovascular and serious skin adverse events in relation to the use of valdecoxib and parecoxib sodium. ......... etc.Information for physicians considering therapy of patients with valdecoxib or parecoxib:
-- Valdecoxib and parecoxib are contraindicated in patients following coronary artery bypass graft (CABG) surgery.
-- Prescribers are advised to carefully follow the latest version of the Summary of Product Characteristics, especially regarding the warnings and precautions in patients with a history of cardiovascular disease.
-- In post-marketing experience serious skin adverse reactions most of which occurred within the first two weeks starting treatment, have been reported in association with valdecoxib.
|
Doctors Say Avoid Pfizer's Bextra -Medical Journal | 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 drug maker's sister drug, Celebrex, doubled risk of heart attacks.
|
Pfizer's Bextra drug may carry new warning label describing deadly skin reaction | Drugmaker Pfizer Inc. is in talks with regulators over a likely change to arthritis drug Bextra's label to carry a strict warning alerting doctors of the risk of a potentially deadly skin reaction, the company said in a regulatory filing.
|
Pfizer Canada Inc. Issues Warnings about BEXTRA* - Cardiovascular Risks and Serious Skin Reactions | SERIOUS SKIN REACTIONS
----------------------
Serious skin reactions (such as Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, and Erythema Multiforme) have been reported in
patients taking BEXTRA since the introduction of the product on the Canadianmarket in January 2003. Healthcare providers' prescribing information and
patients' instructions for BEXTRA are being modified to reflect the higher reported rate of these events with BEXTRA than with other selective COX-2
inhibitor NSAIDs:
- Serious skin reactions (e.g. Toxic Epidermal Necrolysis,
Stevens-Johnson Syndrome, and Erythema Multiforme) have been reported in patients using BEXTRA. Some of these cases have resulted in death.
- These serious skin reactions more commonly occur within the first 2 weeks of treatment, but may occur at any time during treatment.
- These serious skin reactions may occur in patients with or without a known history of a sulfonamide allergy.
- The reported rate of these serious skin events appears to be greater for BEXTRA as compared to other selective Cyclo-oxygenase-2 (COX-2) inhibitor Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Given the potentially serious nature of these skin reactions, patients are advised of the following:
|
Yes, it's probably time for warning | Why, just last month, Pfizer Inc. was reportedly considering putting a warning on its pain reliever Bextra because of some occasional side effects similar to spontaneous combustion and death.
According to a recent Dow Jones Newswire report, Pfizer may be adding a so-called "black box" warning to the prescription drug because it sometimes causes a "serious skin condition."...
If you want to avoid scaring off the entire population of the North American continent - and portions of Brazil and Argentina - you might simply want to indicate "WARNING: May cause symptoms similar to those of Stevens Johnson Syndrome in rare cases."
Stevens Johnson Syndrome, after all, sounds somewhat benign on the surface, and who actually reads those wordy warning labels, anyway?
|
FDA warns of heart risk for Pfizer's Bextra - Pharmaceuticals - Company Announcements | Bextra's new label will also warn of the pain therapy's link to two potentially fatal skin reactions: Steven - Johnson Syndrome and toxic epidermal necrolysis.
FDA said it strengthened Bextra's labeling because the agency is still getting reports of serious skin reactions in patients taking Bextra, and that the condition seems to occur more often in patients on Pfizer's drug than in patients on other COX-2 therapies.
|
Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions and Warning Regarding Cardiovascular Risk | The new boxed warning in the label states that patients taking Bextra have reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis. These skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur any time during therapy. In a few cases, these reactions have resulted in death. The labeling advises doctors that Bextra should be discontinued at the first appearance of a skin rash, mucosal lesions (such as sores on the inside of the mouth), or any other sign of allergic reactions. The new boxed warning also states that Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions.
As of November 2004, FDA had received reports of a total of 87 cases in the United States of severe skin reactions in association with Bextra, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. Twenty of the 87 cases involved patients with a known allergy to sulfa. Of these 87 cases, 36 hospitalizations were reported, including 4 deaths. Other Cox-2 selective inhibitors and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but the reported rate of these serious side effects appears to be greater for Bextra than for other COX-2 agents. ...
|
Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions and Warning Regarding Cardiovascular Risk | Serious Skin Reactions
The new boxed warning in the label states that patients taking Bextra have reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis. These skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur any time during therapy. In a few cases, these reactions have resulted in death. The labeling advises doctors that Bextra should be discontinued at the first appearance of a skin rash, mucosal lesions (such as sores on the inside of the mouth), or any other sign of allergic reactions. The new boxed warning also states that Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions.
As of November 2004, FDA had received reports of a total of 87 cases in the United States of severe skin reactions in association with Bextra, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. Twenty of the 87 cases involved patients with a known allergy to sulfa. Of these 87 cases, 36 hospitalizations were reported, including 4 deaths. Other Cox-2 selective inhibitors and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but the reported rate of these serious side effects appears to be greater for Bextra than for other COX-2 agents.
|
Pfizer Arthritis Pill Gets Heart Warning | As previously reported, the Bextra label also includes a "black box" warning--the most serious kind--for a dangerous skin condition called Stevens-Johnson Syndrome.
But the cardiovascular warning may be as big a problem, even though it is featured less prominently than the skin reaction. Bextra is an anti-inflammatory medicine that works by the same mechanism as Vioxx, the Merck (nyse: MRK - news - people ) pill that was pulled from the market after it was found to double the risk of heart attacks and strokes.
|
| FDA warns on Pfizer's Bextra | US regulators warned yesterday of possible heart risks with Pfizer's Bextra, delivering another blow to popular pain drugs cox-2 inhibitors such as Vioxx, withdrawn from the market by Merck in September.
The Food and Drug Administration has ordered that the label for Bextra include a warning of possible "heart and blood clotting problems". It said patients recently undergoing coronary artery bypass surgery (CABG) should not take it.
|
5 widely used drugs called unsafe / FDA officer says conflicts of interest compromise agency | Washington -- A veteran Food and Drug Administration safety officer Thursday told a Senate hearing inquiring into the abrupt recall of the arthritis drug Vioxx that five other widely used drugs should be either withdrawn or sharply restricted because they have dangerous side effects.
Describing the agency that he works for as incapable of stopping dangerous drugs from coming to and staying on the market, David Graham, associate director of the Office of Drug Safety, told the senators that the FDA's role in reviewing and approving new drugs sometimes conflicted with its duty to address safety issues.
|
| Pfizer Moves Pain-Relief Brands to WPP PR Shops | BOSTON Pfizer has tapped WPP Group's Ogilvy PR and Shire Health to handle U.S. and global public relations, respectively, the company's major pain relief brands, the client confirmed..........Sources pegged the combined PR budget for the two brands at approximately $5 million.
|
FDA Scientist Concerned About 5 Drugs on Market | Nov. 19, 2004 -- David J. Graham, a scientist with the FDA, told U.S. senators about safety concerns he has with five drugs currently on the market.
Here is a list of coverage that WebMD has done on each of these drugs. The FDA is currently investigating Graham's concerns further. No one should stop taking these drugs without talking to their doctor.
Bextra. Used to treat pain and arthritis. Concerns: Two studies have linked the drug with an increase in heart attacks.
Bextra Ups Heart Attack, Stroke Risk
Pfizer Warns of Skin, Heart Risks From Bextra
|
Report: Bextra heart risks similar to Vioxx Study shows arthritis drug has high incidence of attacks, stroke Updated: 9:11 a.m. ET Nov. 10, 2004 NEW YORK - The arthritis drug Bextra, made by Pfizer Inc., has shown a high incidence of heart attacks and strokes among patients, according to an American Heart Association study, the New York Times reported on Wednesday. Bextra is similar to Merck & Co.’s drug Vioxx. Merck voluntarily recalled Vioxx from shelves in late September when a study showed it increased the risk of a cardiac event The AHA’s preliminary study of Bextra was unveiled on Monday at a meeting in New Orleans, which pooled data from 5,930 patients taking part in 12 trials. It found 2.19 times the number of heart attacks or strokes among patients given Bextra, compared with those given placebos, the Times reported.
| “The magnitude of the signal with Bextra is even higher than what we saw in Vioxx. This is a time bomb waiting to go off,” Dr. Garret A. FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania who presented the study, told the Times in an interview. The newspaper said that the new study of Bextra was not considered to be as as persuasive as the trial that led to Vioxx’s withdrawal because it was backward-looking and reorganized data that had been presented in other settings. A spokeswoman for Pfizer told the Times that heart problems with Bextra appeared only in studies involving patients at very high risk of heart disease who were undergoing cardiac surgery -- a detail Pfizer disclosed on Oct. 15. Other studies of Bextra, involving 8,000 patients with arthritis who were followed for 6 to 52 weeks, found no heart problems, she told the newspaper. A representative for Pfizer was not immediately available to comment to Reuters early on Wednesday. |
Pfizer criticized over delay in admitting drug's problems | Pfizer delayed announcing negative data about its painkiller valdecoxib (Bextra), Curt Furberg, a member of the US Food and Drug Administration's Data Safety and Risk Management Advisory Committee, told the BMJ this week. When the company eventually presented its data to the FDA, it also left out important details, Dr Furberg alleges.
Pfizer stood to gain by Merck's withdrawal of rofecoxib on 30 September, after reports linked the drug to increased heart attacks and strokes ( BMJ 2004;329: 816[Free Full Text], 9 Oct). That gain was amplified when a major health insurer, BlueCross BlueShield, announced that they had added valdecoxib to their formulary after the withdrawal of rofecoxib.
Pfizer initially defended valdecoxib, saying the drug was safe in patients with osteoarthritis and rheumatoid arthritis. But on 15 October the company issued a news release, qualifying its earlier statement. The release said, "In two trials in a high-risk surgery known as coronary artery bypass graft (CABG), an increase in cardiovascular events was observed in patients receiving Bextra" (www.pfizer.com).
That news, said Dr Furberg, a member of the FDA's Data Safety and Risk Management Advisory Committee, should have been released earlier. Dr Furberg asked Pfizer, after the withdrawal of rofecoxib, to supply him with data regarding the cardiovascular effects of valdecoxib. "I was struck by what they excluded," he told the BMJ. "They did not mention either of two trials of cardiac surgery patients."
The first of the two trials was published but in a manner that obscured the risks, according to Dr Furberg. He said, "They listed each [adverse] event individually and said the numbers were too small to analyse. But I added up heart attacks, strokes, and deaths and found a statistically significant fourfold increase over placebo."
|
Vioxx Unsafe: So What About Similar Drugs? | Oct. 7, 2004 -- Now that we know Vioxx wasn't safe, can we trust its sister drugs, Bextra and Celebrex? No, argues a New England Journal of Medicine (NEJM) editorial.
Vioxx, like Bextra and Celebrex (and two more drugs not approved in the U.S.) are members of a family called Cox-2 selective inhibitors. All fight pain and inflammation by blocking a molecule called Cox-2.
Blocking Cox-2 also predisposes people to heart attacks, according to a five-year-old theory by Garret FitzGerald, MD, director of the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania in Philadelphia.
|
| Pfizer: Bextra blues A study has generated worrying cardiovascular results for Pfizer's arthritis drug Bextra. | November 12, 2004 5:15 PM GMT (Datamonitor) - Data presented at a recent American Heart Association meeting suggests that Pfizer's [PFE] COX-2 drug, Bextra, approved for arthritis pain, may have worse cardiovascular effects than Merck & Co's [MRK] recently withdrawn Vioxx. Having already been denied an indication for migraine and with the prospect of a black box warning, Bextra could now be in deep trouble.
The incidence of heart attacks and strokes among patients given Pfizer's painkiller Bextra was more than double that of those given placebos in a study pooling data from 5,930 patients in 12 trials. The study's authors accused Pfizer of trying to suppress the information and said the magnitude of Bextra's side effects is even higher than in Vioxx.
|
| Arthritis Drug May Cause Severe Reaction | WebMDHealth.com, November 15, 2002, by Lisa Habib WebMD Medical News. Since Bextra was introduced in March, Pharmacia, Bextra's manufacturer, has reported to the FDA serious and life-threatening skin and hypersensitivity reactions to the drug. These include cases of Stevens-Johnson syndrome, a rare and potentially deadly disorder characterized by inflammation of the mucous membranes of the mouth, throat, genitals, intestinal tract, and membrane lining the eyelids, which can lead to lesions and blisters.
|
|
| Forbes.com: Pfizer Says FDA Warning Likely For Bextra | According to Pfizer Bextra can cause a rare but sometimes life-threatening drug reaction called Stevens-Johnson Syndrome in which the skin, mouth, and eyes can become horribly blistered. Other drugs, including Pfizer's arthritis pill Celebrex, can also cause this condition--but it seems to be more common with Bextra than other medications. Patients taking Bextra who develop the condition tend to get it in the first two weeks of treatment.
Bextra causes Stevens-Johnson Syndrome more often than Celebrex, a similar Pfizer pain drug, and Pfizer has been in discussions with the Food and Drug Administration about how to include the risk in the drug's label. In its third quarter regulatory filing, the drug giant said these discussions would likely to lead to a 'black box' warning'in which warning language is displayed in bold type on a drug's packaging. Pfizer had already communicated the risk to doctors in an Oct. 15 letter
|
|
Pfizer Says Bextra, Heart Problems Linked Oct. 15, 2004 | | The coronary bypass trials are ones that Dr. Eric Topol, of the Cleveland Clinic Foundation and an early and outspoken critic of Vioxx, said he found concerning as they show a cluster of heart attacks and strokes. He said the danger signal does not appear to be as strong as it was with Vioxx. "Celebrex and Bextra do appear safer than Vioxx but whether they are really safe, especially in patients with heart risk, that's an open question," Topol said.
|
|
Heart attack and stroke linked to Pfizer's Bextra | October 18, 2004ST. LOUIS (MD Consult) - On October 15, 2004, Pfizer addressed a letter to health care professionals reviewing information about the cardiovascular profile of its cyclo-oxygenase 2 (COX-2) product Bextra (valdecoxib). In 2 trials in the high-risk surgery coronary artery bypass graft, an increase in stroke and heart attack was observed in patients receiving Bextra alone or in combination with the investigational drug parecoxib (an intravenous formulation).
|
|
Pfizer Warns of Skin, Heart Risks From Bextra | Febr Oct. 15, 2004 -- Bextra -- one of two U.S. approved Vioxx sister drugs -- may cause rare skin and heart side effects, its manufacturer today warned doctors.
The warning comes in the wake of Merck's voluntary withdrawal of Vioxx. That action came after a clinical trial confirmed that Vioxx increased patients' risk of heart attack and stroke.
|
|
Pfizer sees possible risk to heart patients in a painkiller | Pfizer Inc. warned doctors yesterday that one of its best-selling painkillers, Bextra, might raise the risk of a heart attack or stroke in patients who have had coronary artery bypass surgery.
The announcement comes just two weeks after Merck pulled its painkiller, Vioxx, which is in the same class of drugs as Bextra, from the market because a study showed that the risk of heart attacks doubled for patients who had taken Vioxx for 18 months or longer.
Pfizer said a clinical study involving more than 1,500 patients showed that those who had undergone bypass surgery and had taken Bextra intravenously and orally were at higher risk for heart attacks. An initial study last year raised similar concerns in the same kinds of patients.
|
Breaking News: Pfizer May Issue Stiff Warning for Pain Killer Bextra | Febr NEW YORK (Dow Jones)--Pfizer Inc. (PFE) said Friday it's likely that a so-called "black box" warning will be added to the label of its pain killer Bextra because it sometimes leads to a rare but serious skin reaction.
(Explanation of Stevens Johnson syndrome starting in 12th paragraph listed below) The skiThe skin reaction, known as Stevens Johnson syndrome, is included as a warning on the packages of many drugs on the market, but "few, however, have black box warnings," Anderson said.
Stevens Johnson Syndrome
Stevens Johnson syndrome occurs when the immune system turns on itself to rid itself of a drug, in effect burning the patient from the inside out, Jean Farrell-McCawley, founder of the Stevens Johnson Syndrome Foundation, said.
It leads to severe, painful blistering of the mucous membranes and skin. In many patients, their skin actually starts coming off in sheets, she said. In about 80% of cases, the drug reaction ends up affecting the eye by burning the corneas and can lead to blindness.
"The people are usually hospitalized in a burn unit," she said, adding that many have to be put on feeding tubes and ventilators. Stevens Johnson has about a 30% mortality rate, she said
|
FDA, PHARMACIA UPDATE BEXTRA LABEL WITH NEW WARNINGS 2002 FDA and Pharmacia are advising health care professionals about new warnings and information in the product labeling of the drug Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). The labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions -- including Stevens Johnson Syndrome, and anaphylactoid reactions (serious allergic reactions). In addition, the labeling will state that the drug is contraindicated -- not to be used -- in patients allergic to sulfa containing products. On November 13, 2002, Pharmacia, the manufacturer of Bextra sent letters to health care professionals advising them of postmarketing reports and new warnings that will be included in the drug label. Since the firm began marketing the drug in March of 2002, cases of the serious skin and hypersensitivity reactions have been reported. These included cases of Stevens Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme. Although these adverse events are rare, some of these patients required hospitalization. | Febr Based on these reports, FDA has approved labeling changes for Bextra that include a warning for serious skin reactions. As these reactions can be life threatening, people who start Bextra and experience a rash should discontinue the drug immediately. Health care professionals are encouraged to report any unexpected adverse or serious events associated with the use of Bextra directly to Pharmacia Corporation Peapack, N.J. at 1-800-323-4204 FDA MedWatch program at 1-800-FDA-1088. The Medwatch form is available online for download at http://www.fda.gov/medwatch/safety/3500.pdf By mail (or fax, 1800-FDA-0178) MedWatch, HFD-410, FDA 5600 Fishers Lane Rockville, MD 20857 |
MedWatch - BEXTRA Dear Healthcare Professional letter 2002
2002 Safety Alert - BEXTRA (valdecoxib tablets) | This is the text of a letter from Pharmacia and Pfizer. Contact the companies for a copy of any referenced enclosures.November 13, 2002 Dear Healthcare Professional, Pharmacia and Pfizer would like to inform you about recent changes to the product labeling for BEXTRA ®
(valdecoxib tablets). BEXTRA is indicated for relief of the signs and symptoms of osteoarthritis and adult
rheumatoid arthritis,and for the treatment of primary dysmenorrhea.
Since BEXTRA was approved by the FDA on November 16,2001, in postmarketing experience, rare spontaneous reports of hypersensitivity reactions (i.e., anaphylactic reactions and angioedema) and skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme, have been received for patients treated with BEXTRA. These cases, some of which were serious/life threatening,have occurred in patients with and without a history of allergic-type reactions to sulfonamides. In order to communicate this important postmarketing information to healthcare professionals, the following
information has been added to the package insert: CONTRAINDICATIONS: BEXTRA should not be given to patients who have demonstrated allergic-type reactions to sulfonamides. WARNINGS -Serious Skin Reactions: Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported through postmarketing surveillance in patients receiving BEXTRA (see ADVERSE REACTIONS-Postmarketing Experience). As these reactions can be life threatening, BEXTRA should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. WARNINGS -Anaphylactoid Reactions: In postmarketing experience, cases of hypersensitivity reactions (anaphylactic reactions and angioedema) have been reported in patients receiving BEXTRA (see ADVERSE REACTIONS-Postmarketing Experience). These cases have occurred in patients with and without a history of allergic-type reactions to sulfonamides (see CONTRAINDICATIONS). ADVERSE REACTIONS-Postmarketing Experience: The following reactions have been identified during
postmarketing use of BEXTRA. These reactions have been chosen for inclusion either due to their seriousness, reporting frequency, possible causal relationship to BEXTRA, or a combination of these factors. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General: Hypersensitivity reactions (including anaphylactic reactions and angioedema)
Skin and appendages: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic
epidermal necrolysis
Pharmacia and Pfizer are committed to the safety and well being of all patients receiving BEXTRA (valdecoxib tablets). If you become aware of any case(s) of the events described above, in patients treated with BEXTRA, please report the event promptly. You may contact Pharmacia at 1-800-253-8600 extension 38244, or the FDA MedWatch program, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20857, or by the Internet at https://www.accessdata.fda.gov/scripts/medwatch/.
If you have any questions, please contact Pharmacia ’s Medical and Drug Information at 1-800-323-4204.
Please see the revised full prescribing information for BEXTRA enclosed with this letter.
Sincerely,
James B.Jones,MD, PharmD
Medical Director
Arthritis and Pain
Global Medical Affairs
Pharmacia Corporation
| Mona M. Wahba, MD
Medical Director
COX-2 Worldwide Team
Pfizer Inc
|
Title:
Rising Prescription Drug Use Corresponds to Increase in Stevens Johnson
Syndrome; SJS Foundation Issues Warning Signs.
Date: 12/13/2004; Publication: Business Wire;
Bextra
Label Updated with Boxed Warning Concerning Severe Skin Reactions
With more than 40 percent of Americans taking at least one prescription
drug (2004 CDC report), the potential for the deadly adverse drug reaction
known as Stevens Johnson Syndrome (SJS) is increasing.
Described in many drug warning inserts as a "serious skin condition," SJS
is actually a devastating reaction affecting the skin and mucous membranes,
causing severe burning, blistering and sloughing of involved tissue.
SJS commonly causes blindness and results in death in 10 to 30 percent
of the cases.
An under-reported and under-recognized condition, people develop SJS
from commonly prescribed drugs, including antibiotics, anti-convulsants,
and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter
drugs such as adult and children ibuprofen products. Because many physicians
and emergency facilities are not familiar with the symptoms, treatment
is frequently delayed, further exacerbating the condition.
To recognize SJS in its earliest stage, the SJS foundation urges patients
and physicians to watch for the following symptoms when taking medications:
--Persistent fever
--Burning or blistering of the mucous membranes, i.e.: eyes, ears, mouth,
nose, genital area.
--Rash, blisters or red splotches on skin
--Flu-like symptoms
--History of a reaction to prescribed drugs or over-the-counter medications.
In one estimate, SJS is reported to effect three to eight people per
million per year in the U.S. However, the frequency could be much
higher since only one percent of adverse drug reactions is reported,
according to the Food and Drug Administration.
"SJS is not as rare as we are led to believe," said Jean McCawley,
president of the SJS Foundation. "As prescription drug use increases,
we are being contacted by increasing numbers of people. During the winter months,
we learn of 15 new cases a week, and that's only people with Internet access."
About SJS Foundation
Founded in 1995, the Stevens Johnson Syndrome Foundation (Julie Foundation
for allergic drug reactions) is a non-profit organization that provides
information and support for victims, educates the medical community and
encourages research in preventing adverse drug reactions. More information
is available at www.sjsupport.org.
Note to Media: Personal stories, photos and videotape are available upon
request.
HighBeam Research
Title: NSAID may warrant black box warning.(News
pulse: monitoring research and trends in clinical care)(non-steroidal
anti-inflammatory drugs)
Date: 12/1/2004; Publication: Geriatrics;
The cyclo-oxygenase-2 (COX-2) inhibitor, Pfizer's Bextra
(valdecoxib), may soon carry a black box warning on its label, according
to the manufacturer's filing with the Securities and Exchange Commission
(SEC).
The U.S. Food and Drug Administration (FDA) approved the non-steroidal
anti-inflammatory drug of the COX-2 inhibitor class for the treatment
of symptoms associated with osteoarthritis and rheumatoid arthritis.
In October 2004, Pfizer mailed a letter to physicians cautioning of the
risk of a rare but serious skin reaction known as Stevens-Johnson syndrome
in patients using Bextra. The label has contained information on the
condition since 2002, but Pfizer recently announced it would revise the
label to note that risk of this syndrome is greater with Bextra than
with other COX-2 inhibitors, and that the risk is greatest during the
first 2 weeks of therapy.
In a document filed with the SEC, Pfizer stated it is in deliberation
with the FDA regarding the label and potential black box warning.
In addition to the Stevens-Johnson syndrome risk, rare reports have surfaced
of various other skin disorders associated with administration of valdecoxib
since the drug was first marketed in March 2002, according to Norman
Levine, MD, Geriatrics contributing author. He said the exact number
of such cases is not known with certainty.
...
FDA
NSAID decision Memo
The
agency should ask Pfizer to voluntarily withdraw Bextra
(valdecoxib) from the U.S. market. In the event Pfizer does not agree
to a voluntary withdrawal, the agency should initiate the formal
withdrawal procedures; i.e., issuance of a Notice of Opportunity
for Hearing (NOOH).
• The professional labeling for all prescription NSAIDs should be revised
to include a boxed warning highlighting the potential increased risk of serious
adverse CV events. The boxed warning should also include the well described
NSAID class risk of serious, and often life-threatening, GI bleeding, which
is currently contained in a bolded warning.
• Pending the availability of additional data, the labeling for all prescription
NSAIDs should include a contraindication for use in patients immediately post-operative
from CABG surgery.
Drug
Safety Oversight Board
Public
Meeting Summaries
FDA's New Drug Safety Initiative
FDA is launching a new program to make drug safety information available
to you in an easily accessible format. Because patients are taking a
more active role in their healthcare, we want to make safety information
available about the medicines they are using. We believe that patients,
their healthcare professionals, and other consumers will find the information
we are providing useful in their prescribing and treatment decisions.
Our Drug Safety Initiative has the following components:
Drug safety information located together in a new web location
Drug specific information for healthcare professionals, patients, and
other consumers
Other consumer education
Draft Guidance: FDA’s “Drug Watch” for Emerging Drug
Safety Information [PDF] [Word] [HTML]
Federal Register Notice of Availability -- Draft Guidance for Industry
on the Food and Drug Administration's "Drug Watch'' for Emerging
Drug Safety Information [PDF] [HTML] (5/10/2005)
Manual of Policies and Procedures (MaPP): Drug Safety
Oversight Board (DSB)
Drug Safety Oversight Board Members [PDF] [HTML]
Drug Safety Oversight Board Meetings: Public Summaries
Questions and Answers on FDA's New Drug Safety Initiative [PDF] [Word]
[HTML]
Secretary Leavitt's February 2005 Press Release
All NSAIDs May Be Linked to MI Risk, Study Indicates
"of these drugs in elderly people and the increased
risk of myocardial infarction with age, even the relatively large number
of patients needed to harm could have considerable implications for
public health," they note......
"We think that enough concerns exist to warrant a reconsideration of the
cardiovascular safety of all NSAIDs," the investigators conclude.
Heart
Attack > COX-2 Inhibitor Increases Risk of Heart Attack in Low-risk
Seniors
New research published in the online version of the Annals
of Internal Medicine documents an increased risk of heart attack with
one of the COX-2 inhibitors used in elderly adults with no previous
history of heart attack, a group previously considered low risk.
Pfizer
Takes Painkiller Bextra Off
Market
he painkiller Bextra was taken off
the market Thursday, and the government wants other drugs in the
same class to carry the strongest possible warnings about increased
risk of heart attack and stroke among the millions of people who
rely on them.
Pfizer Inc. suspended sales of Bextra in the United States and the European
Union at the request of the Food and Drug Administration and European
regulators. The company said the FDA, in seeking its withdrawal, cited
a risk of serious skin
reactions to Bextra.
Pfizer
Suspends Bextra Sales
The FDA said it singled out Bextra
for suspension because it gives no added advantage as a painkiller
and can cause a potentially life-threatening skin condition called
Stevens-Johnson syndrome, an allergic reaction that usually begins
as a blistering of the mouth and lips and can spread to the rest of
the body.
Pfizer
Withdraws Bextra On FDA Request
The Food and Drug Administration
has asked Pfizer to withdraw Bextra, the controversial arthritis
drug, and to add a strong, boxed warning to the label of Celebrex.
Pfizer has agreed to the measures, but will further discuss the labels
with the FDA. In doing so, the agency takes a much harder line than
the advisory panel that met ina
|
|