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.
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.
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.
tFDA Alert [4/7/2005]:
FDA has requested that Pfizer voluntarily withdraw Bextra from the United States market. Pfizer has agreed to suspend sales and marketing of Bextra in the United States pending further discussion with the Agency. At this time the Agency has concluded that the overall risk versus benefit profile of Bextra is unfavorable. This conclusion is based on the potential increased risk for serious Cardiovascular (CV) Adverse Events which appears to be a class effect of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (excluding aspirin) an increased risk of serious skin reactions (e.g. toxic epidermal necrolysis Stevens-Johnson syndrome erythema multiforme) compared to other NSAIDs and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs.
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