Valdecoxib: Difference between revisions
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==External link== |
==External link== |
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*[http://www.fda.gov/cder/drug/InfoSheets/HCP/valdecoxibHCP.htm FDA Alert on Bextra withdrawal] |
*[http://www.fda.gov/cder/drug/InfoSheets/HCP/valdecoxibHCP.htm FDA Alert on Bextra withdrawal] |
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*[http://www.thebextralawyer.net The Bextra Lawyer] Useful news updates and commentary about the latest Bextra news |
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[[Category:Non-steroidal anti-inflammatory drugs]] |
[[Category:Non-steroidal anti-inflammatory drugs]] |
Revision as of 20:16, 10 May 2005
4-(5-methyl-3-phenyl-4-isoxazolyl)-benzenesulfonamide | |
CAS number 181695-72-7 |
ATC code M01AH03 |
Chemical formula | C16H14N2O3S |
Molecular weight | 314.364 |
Bioavailability | 83% |
Metabolism | 10% |
Elimination half-life | 8-11 hours |
Excretion | 90% |
Pregnancy category | In late pregnancy, valdecoxib should be avoided because it may cause premature closure of the ductus arteriosus. |
Legal status | Recalled in US, EU, Canada & parts of Asia |
Routes of administration | 10mg Oral |
Information Source: | "FDA Bextra Labeling Information" (PDF). FDA Bextra Labeling Information. April 8. {{cite web}} : Check date values in: |date= and |year= / |date= mismatch (help)
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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 is manufactured and marketed under the brand name Bextra® by G. D. Searle & Company. It is available by prescription in tablet form.
On April 7, 2005, Pfizer withdrew Bextra from the US market on recommendation by the FDA.
Recall and lawsuits
Since as early as October 2004, personal injury firms have accepted new clients who have been seriously injured by the pain reducing medication Bextra. Bextra was prescribed to millions of Americans to treat the pain associated with arthritis, menstrual discomfort, and other ailments. Now, in light of the Food and Drug Administration’s demand that Bextra’s manufacturer, Pfizer, pull the drug from the market, firms anticipate an increase in individuals seeking to file suit to get compensation for their injuries.
On April 7, 2005 the FDA asked Pfizer, Inc. to withdraw the drug from the market because the overall risk versus benefit profile for the drug is unfavorable. Common risks associated with the drug include angina, heart attack, stroke, fatal skin reactions, and Stevens Johnson syndrome. Pfizer first acknowledged risks associated with Bextra in October of 2004. The American Heart Association soon after was presented with a report indicating patients using Bextra while recovering from heart surgery were 2.19 times more likely to suffer a stroke or heart attack than those taking placebos.
With the FDA’s request for the removal of the drug, there will undoubtedly be new awareness of the dangers associated with Bextra, and many users will want to know their rights and means of legal recourse. Law firms with dedicated team of lawyers and client relations specialists who have been reviewing Bextra claims for months, are answering questions and advising Bextra users of their best course of legal action.
In addition to requesting Pfizer to pull Bextra from the market, the FDA has also asked the company to include a black box warning in the Celebrex label highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with its use.
Personal injury law firms are concentrating on the most serious Bextra and Celebrex-related injuries; heart attacks, strokes, severe skin reactions, Stevens-Johnson syndrome, and death, paying particular attention to the dosage and frequency with which the drugs were taken when evaluating potential lawsuits.
External link
- FDA Alert on Bextra withdrawal
- The Bextra Lawyer Useful news updates and commentary about the latest Bextra news