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Sales of Bextra end at FDA's request.
Byline: Alan Bavley
Apr. 8--With Bextra, Guadalupe Hutfles had found just the right drug to control the unbearable pain of her fibromyalgia and connective tissue disease.
But Thursday, Hutfles learned from her doctor that she would be losing this lifeline.
At the urging of the Food and Drug Administration, Bextra's manufacturer, Pfizer Inc., was suspending sales of the pain reliever over health concerns.
The action was one in a series the FDA announced Thursday to warn the public about potential hazards of an array of pain relievers called non-steroidal anti-inflammatory drugs, or NSAIDs, that are used by millions of people with arthritis and other conditions.
"Literally, I just want to cry," Hutfles said after hearing the news. "I cried with the doctor. He…
- New FDA Labeling for Pfizer's Celebrex and All Other NSAIDs to Reflect Similar...
- Press release article from: PR Newswire April 7, 2005 700+ words
...arthritis pain. Regarding Bextra, Pfizer's other...2 inhibitor, the FDA informed Pfizer late...respectfully disagrees with FDA's position regarding...benefit profile of Bextra. However, in deference...was informed by the FDA of its conclusions regarding Celebrex and Bextra on ...
- UPDATE 2-Pfizer ads for Celebrex, Bextra mislead, says FDA.
- News wire article from: The America's Intelligence Wire January 12, 2005 700+ words
...drugs Celebrex and Bextra are misleading. The FDA said in a letter dated...Celebrex, as well as a Bextra direct mail brochure...dissemination of the FDA-approved product...used long-term. Bextra also was cited last fall by FDA whistleblower David...
- Celebrex, Bextra likely to benefit from FDA review.(MERCHANDISING)(Brief...
- Magazine article from: MMR April 25, 2005 700+ words
...higher sales of two of them--Bextra and Celebrex. That probability...particularly anticipated increasing their Bextra prescriptions. And internists...treatment--after Celebrex and Bextra. Meanwhile, the FDA has taken action to be more open...
- Top NSAID Litigation Attorney James Barber Praises FDA Action on Bextra and...
- Press release article from: Business Wire April 11, 2005 700+ words
...and Drug Administration (FDA) for its recent action on Bextra, but urged the FDA to act quickly in requiring...Necrolysis (TEN) associated with Bextra," said Barber. "The action taken last week by the FDA took our efforts one step...
- FDA will require new Bextra warnings. (Washington Insider).(U.S. Food and Drug...
- Magazine article from: Medical Marketing & Media January 1, 2003 700+ words
...marketing its new COX-2 drug Bextra (valdecoxib), the FDA is requiring new warnings on the...sulfa-containing products. Bextra was approved in November 2001...dysmenorrhea (menstrual pain). Bextra's label change came as a result...
- Pfizer ads for Celebrex, Bextra mislead, says FDA.
- News wire article from: The America's Intelligence Wire January 12, 2005 700+ words
...its ads for arthritis drugs Celebrex and Bextra are misleading. The FDA said in a letter dated Jan. 10 and released...of heart problems when used long-term. Bextra was also cited last fall by FDA whistleblower David Graham as possibly raising...
- UPDATE 1-Pfizer ads for Celebrex, Bextra mislead, says FDA.
- News wire article from: The America's Intelligence Wire January 12, 2005 700+ words
...its ads for arthritis drugs Celebrex and Bextra are misleading. The FDA said in a letter dated Jan. 10 and released...of heart problems when used long-term. Bextra was also cited last fall by FDA whistleblower David Graham as possibly raising...
- FDA approves warning label for Pfizer's Bextra drug.
- Newspaper article from: Knight Ridder/Tribune Business News December 10, 2004 700+ words
...and acetaminophen. The FDA said the new labeling about Bextra's possible side effects...after such surgery with Bextra compared to a placebo. FDA officials said the risk...intravenous injections of Bextra compared with patients taking...
- BEXTRA(R) (valdecoxib tablets) Approved by FDA for Treating the Pain and...
- Press release article from: PR Newswire November 19, 2001 700+ words
...Food and Drug Administration (FDA) has approved BEXTRA(R) (valdecoxib tablets...associated with menstrual cramping. BEXTRA, which is indicated for arthritis...involving more than 5,000 patients, BEXTRA demonstrated comparable efficacy...
- FDA puts Bextra on do-not-sell drug list.
- News wire article from: Record (Hackensack, NJ) April 8, 2005 700+ words
...broad review, the FDA decided that Bextra should be removed...to the change with Bextra," Dr. Stephen Galson...acting director of the FDA's Center for Drug...Pfizer said the FDA told the company about its view on Bextra late Wednesday...
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