Bextra
What is Bextra?
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.
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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.
Side Effects and Withdrawals of Bextra.
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 Related to Bextra
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.
- FDA recommends that patients being treated with Bextra be switched to an alternative therapy.
- Bextra has been demonstrated to be associated with an increased risk of serious adverse CV events in two short-term trials in patients immediately post-operative from coronary artery bypass graft (CABG) surgery. Data are not available from long-term controlled clinical trials to evaluate the cardiovascular safety of Bextra following chronic use. FDA has concluded that it is reasonable to extrapolate the adverse CV risk information for Bextra from the short-term CABG trials to chronic use given the fact that other COX-2 selective NSAIDs have been shown in long-term controlled clinical trials to be associated with an increased risk of serious adverse CV events (e.g. death MI stroke) and the well described risk of serious and often life-threatening gastrointestinal bleeding.
- Bextra is a sulfonamide and already carries a boxed warning in the package insert for serious and potentially life-threatening skin reactions (e.g. toxic epidermal necrolysis Stevens-Johnson syndrome erythema multiforme). The reporting rate to FDA’s spontaneous reporting system for these serious skin reactions is significantly greater for Bextra than other COX-2 selective agents. The risk of these serious skin reactions in individual patients is unpredictable occurring in patients with and without a history of sulfa allergy and after both short- and long term use.
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