Bextra Side Effects Lawsuit
Bextra, a valdecoxib tablet, is used for oral administration to relieve the symptoms of osteoarthritis, adult rheumatoid arthritis, and for the treatment of primary dysmenorrheal.The tablets contain either 10mg or 20mg of veldecoxib.
The inactive ingredients in Bextra include:
Bextra Tablets are white, capsule shaped, film-coated, 10mg or 20mg tablets with a four pointed star shape on one side and “10” or “20” debossed on the opposite side. Bextra is supplied as a bottle of 100, a bottle of 500, or a carton of 100 unit doses. It should be stored at 77°F but its excursions are permitted to 59-86°F.
Food has no significant effect on either the peak concentration or the extent of absorption of valdecoxib, therefore, Bextra can be taken with or without food. No significant effect on either the rate or extent of absorption of valdecoxib occurs when the administration of Bextra is combined with an antacid.
Valdecoxib is a non-steroidal, anti-inflammatory drug (NSAID) that exhibits, in animals, anti-inflammatory, antipyretic and analgesic properties. Inhibition of prostaglandin synthesis primarily through inhibition of cyclooxygenase-2(COX-2) is believed to result in the mechanism of action. In humans veldecoxib does not inhibit COX-2 at therapeutic plasma concentrations. The Valdecoxib found in Bextra is a diaryl substituted isoxazole and is chemically designated as 4-(5-methyl-3-phenyl-4-isoxazolyl) benzenesulfonamide. Its molecular weight is 314.36 and it is a crystalline white powder that is relatively insoluble in water at 25° C and pH 7.0. Valdecoxib is soluble in methanol and ethanol, and organic solvent and alkaline aqueous solutions. The empirical formula for Vadecoxib is C16H14N2O3S.
Approximately 3 hours after use Valdecoxib achieves its maximal plasma concentration. Following oral administration of Bextra,when compared to the intravenous infusion of valdecoxib, the absolute bioavailability of veldecoxib is 83%.
The dose recommended of Bextra Tablets for relief of symptoms of arthritis is 10mg once a day. The dose recommended of Bextra Tablets to treat primary dysmenorrrhea is 20mg, two times a day, as needed.
If an overdose were to occur, patient should be managed by symptomatic and supportive care. There are no specific antidotes and dialysis is unlikely to be useful in the occurrence of an overdose. Due to high protein binding, alkalinization of urine, diuresis or hemoperfusion may also not be useful in the occurrence of an overdose.
Patients who have demonstrated any type of allergic reactions to sulfonamides should not be given Bextra. The tablets are not recommended in patients with known hypersensitivity to valdecoxib. Patients who have experienced asthma, urticaria, or allergic reactions after taking aspirin or NSAIDs should not use Betrax as severe, anaphylactic reactions are possible.
In September of 2009, Bextra was mention in allegations that Pfizer had illegally marketed several drugs including Geodone, Bextra, Zyvox, and Lyrica. Pfizer agreed to a settlement with the U.S. department of Justice of 2.3 billion dollars to resolvet he allegations. This agreement was the largest healthcare fraud settlement in the history of the U.S. Department of Justice.
The following side effects and adverse reactions are associated with the use of Bextra:
congestive heart failure
coronary artery disorder
stool frequency increased
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