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Valdecoxib

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. FDA Bextra Labeling Information. URL accessed on April 8, 2005.

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.

Contents

  • 1 Uses
  • 2 Side-effects and withdrawal
  • 3 Personal injury
  • 4 External link

Uses

Since its registration, Bextra was prescribed for pain associated with arthritis, menstrual discomfort, and other ailments.

Side-effects and withdrawal

On April 7, 2005, Pfizer withdrew Bextra from the US market on recommendation by the FDA, citing an increased risk of heart attack and stroke and also the risk of a serious, sometimes fatal, skin reaction. This was a result of recent attention to prescription NSAIDs, such as Merck's Vioxx. Other reported side-effects were angina and Stevens-Johnson syndrome.

Pfizer first acknowledged cardiovascular 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.

Personal injury

With the removal of the drug from the market, there is expected to be a surge in personal injury claims, many in the form of class action, to seek compensation.

External link

  • FDA Alert on Bextra withdrawal

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