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Bextra Lawsuit Inquiry Form : Blog Home : April 2005 : 2005-04-04 to 2005-04-10
Ten members of the Food and Drug Administration advisory panel who voted that a group of powerful pain killers should continue to be sold had ties to the drug makers, a new analysis shows.
After three days of hearings on the drugs, known as Cox-2 inhibitors, the panel voted 31-1 to keep Pfizer's Celebrex on the market, 17-13 with 2 abstentions in favor of Pfizer's Bextra and 17-15 that Merck's Vioxx should be allowed back on sale.
Without those ballots the vote would have been 13-7 in favor of withdrawing Bextra and 14-8 to keep Vioxx off sale.
Common Mis-spellings for the drug BextraApril 7, 2005 14:58
Are you having trouble find the drug "Bextra" on the web. Be careful that you have spelled it correctly.
Common mis-spellings include:
Pfizer Inc. said Thursday that the Food and Drug Administration asked it to pull its arthritis painkiller Bextra from the market. April 7, 2005 15:33
The following is from the FDA statement:
FDA has asked Pfizer, Inc. to withdraw Bextra (valdexocib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label.
Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex.
FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.
In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.
This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.
These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency's Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.
To inform the public and healthcare community of its decisions, FDA today issued a Public Health Advisory (PHA) and updated patient and healthcare practitioner fact sheets.
Additional information about today's announcements is available on FDA's Web site at www.fda.gov/cder. Information can also be obtained by calling 1-888-INFO-FDA (888-463-6332).
Health Canada, Pfizer discontinue sales, Arthritis drug Bextra, Bextra off the market in Canada April 7, 2005 15:50
Health Canada has asked drug maker Pfizer to immediately discontinue sales of its arthritis drug Bextra, the same day it was pulled from the U.S. market.
Health Canada asked drug maker Pfizer on Thursday to immediately discontinue sales of its arthritis drug Bextra, the same day sales were suspended in the U.S. and Europe until concerns about its safety are cleared up.
In seeking Bextra's withdrawal, Pfizer says the FDA cited a risk of the drug causing a potentially fatal skin reaction.
Pfizer says it disagrees with the FDA and Health Canada on Bextra's safety.
The regulator said it called for Bextra's withdrawal from store shelves because of the skin condition risk.
Pfizer mmediately discontinue sales, Bextra, Pulled from the U.S. market.April 7, 2005 15:51
Pfizer says it disagrees with the FDA and Health Canada assessment of Bextra's safety.
However, Pfizer suspended sales of the drug in the United States and the European Union following a request from the U.S. Food and Drug Administration and European regulators.
In seeking Bextra's withdrawal, Pfizer says the FDA cited a risk of the drug causing a potentially fatal skin reaction.
Health Canada says it will request more safety.
Drug maker Pfizer says it is pulling its arthritis painkiller Bextra off the market. The FDA asked for the recall after finding possible dangers from the drug outweigh their benefit.
Drug maker Pfizer says it is pulling its arthritis painkiller Bextra off the market. The FDA asked for the recall after finding possible dangers from the drug outweigh their benefit.
Pfizer said it planned further discussions with the FDA hoping to return Bextra to the market but for now advised patients to stop taking the drug and talk to their doctor about other treatments.
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Arthritis Drug Yanked From Market FDA Asks Pfizer To Withdraw Bextra Because Of Risks
The government has asked Pfizer to withdraw the painkiller Bextra from the market because it increases the risk of heart attack and stroke.
Pfizer has agreed to yank the drug. Pfizer to suspend sales and marketing of Bextra in the United States, pending further discussions with the Food and Drug Administration.
Advisers to the FDA in February recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to continue to use them despite the health risks.
Pfizer will also suspend sales of Bextra in the European Union, at the request of European regulators.
The FDA also said there have been reports of serious skin reactions, and even deaths, in patients using Bextra. The agency said the risk of these reactions is unpredictable. (SJS).
Stephens Johnson Syndrome risks of Bextra cause FDA to ask for a withdraw.
Pharmaceutical giant Pfizer Inc. said this week it will cut $4 billion in costs by 2008 to bolster profits as demand wanes for its controversial painkillers Celebrex and Bextra and patents expire on some of its other popular brand-name medicines. Recent controversy about the safety of pain relievers for arthritis and other chronic diseases have many worried. Some prescriptions that arthritis sufferers have depended on for years, Vioxx, Bextra and Celebrex, remain on the shelf, but now require warning labels based on concerns about patient safety. Pfizer Inc on Tuesday forecast double-digit profit growth in 2006 and 2007 on aggressive cost-cutting and revenue from new medicines, but the drug maker said generic competition and falling arthritis drug sales would drag down 2005 earnings.
HARD SELL: How Marketing Drives the Pharmaceutical Industry
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2005/03/03/BUGQVBJDI01.DTL&type=health
One in an occasional series. The sudden halt to sales of the newly approved multiple sclerosis drug Tysabri this week, following alarms about the widely marketed painkillers Celebrex, Vioxx and Bextra, raises some tough questions about the U.S. drug safety system.
A Food and Drug Administration advisory panel voted Friday to let doctors prescribe COX-2 painkillers, including Celebrex and Vioxx, but recommended stronger warnings about the risk of heart attacks and strokes. Ten members of the Food and Drug Administration advisory panel who voted that a group of powerful pain killers should continue to be sold had ties to the drug makers, a new analysis shows. Celebrex and Vioxx were ''peddled" indiscriminately through widespread TV ads even though only 5 percent of all the people taking painkillers actually needed the new drug's stomach-protecting benefits, US Senator Edward M. Kennedy said yesterday. Merck's best defense in the cascade of lawsuits it faces from consumers who claim they were harmed by taking Vioxx is crumbling. That isn't because of any missteps by the company. Vioxx, Celebrex and Bextra may have passed the acid test when a 32-advisors panel voted for the drugs to remain on the shelves, but the controversy they created have opened the eyes of the average American to the side effects presented by drugs.
After the Food and Drug Administration insisted for months that it did nothing wrong in its oversight of the withdrawn pain pill Vioxx, a top agency official acknowledged "lapses" in the agency's actions before a Senate panel on Tuesday. The Food and Drug Administration asked Congress on Tuesday for authority to dictate label changes for drugs to end the type of haggling with pharmaceutical companies that delayed warnings to Vioxx users about potential heart problems.
Users of the painkiller Vioxx were kept in the dark for more than a year about the drug's potential dangers because the Food and Drug Administration lacked the authority to demand safety-related changes in the product's labeling, an agency official told Congress on Tuesday.
On Thursday, Bextra became the first prescription painkiller to be pulled off the market by the Food and Drug Administration. Pfizer Takes Bextra Off Market. And the FDA wants 19 other painkillers to carry tough new warnings. The United States and the European Union asked pharmaceutical giant Pfizer to withdraw Bextra, its eighth-best seller globally, from the market. As a result, Pfizer Inc. Thursday agreed to suspend sales of its arthritis drug Bextra after U.S. and European regulators said the risk of serious side effects, including a potentially fatal skin allergy, outweigh the benefits. Pfizer Inc. pulled its troubled painkiller Bextra from U.S. and European pharmacies Thursday after the Food and Drug Administration said the medication posed a risk of rare but life-threatening skin reactions. The painkiller Bextra was removed from the market yesterday by Pfizer Inc. at the request of Food and Drug Administration officials who said concerns about side effects such as life-threatening skin reactions and heart problems outweigh its benefits.
The blockbuster painkiller Bextra was yanked off the market Thursday, and the government ordered that 19 other popular prescription competitors from Celebrex to Mobic to high-dose naproxen carry tough new warnings that they, too, may increase the risk of heart attacks and strokes.
Since Pfizer halted Bextra sales at FDA request, Pfizer Inc.'s earnings are likely to slump further this year and its recently released plan to return to double-digit earnings growth in 2006 and 2007 could be in jeopardy because of Thursday's decision by federal regulators to ban the sale of Bextra, one of its blockbuster pain relievers, analysts said. US health officials asked Pfizer to halt sales of its Bextra arthritis medication due to potential risks, and ordered new warning labels for others in a similar class of drugs, including Pfizer's Celebrex.
The public can call the Pfizer hotline 1-800-18-2929 to find out more about the painkiller drug Bextra that has been removed from the market.
The blockbuster painkiller Bextra was yanked off the market Thursday, and the government ordered that 19 other popular prescription competitors - from Celebrex to Mobic to high-dose naproxen - carry tough new warnings that they, too, may increase the risk of heart attacks and strokes.
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