There are indications that Pfizer, the pharmaceuticals corporation responsible for producing Bextra, failed to conduct appropriate clinical studies of the arthritis drug before introducing it to the market. Nearly three years after Bextra was launched to the public, the FDA asked Pfizer to withdraw Bextra because the overall risk versus benefit profile for the drug was deemed “unfavorable.” The FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label, a pharmaceutical that has come under scrutiny following the recall of Vioxx in September of 2004.
In response to FDA pressure, Pfizer agreed to suspend sales and marketing of Bextra in the U.S. on April 7, 2005, pending further studies and discussions with the FDA. Further investigations may reveal flaws in the studies used to gain FDA approval or the Pfizer practice of ignoring possible warning signs. Shortly before Bextra was withdrawn, the FDA halted the production of all television and print ads for both of Pfizer’s Celebrex and Bextra. The FDA claimed that the pharmaceuticals giant failed to adequately emphasize the drugs’ health risks to consumers. Both drugs are associated with increased cardiovascular and gastro-intestinal health risks. In response to these shortcomings, the FDA demanded enhancements in the warning information featured on the medications’ labels.
Pfizer’s practice of providing inadequate warning labels and aggressively marketing its poorly-labeled drugs may be indicative of a broader corporate recklessness or negligence regarding its introduction and promotion of Bextra. While unknown millions of Bextra users were put at risk of potentially fatal side effects, Pfizer collected billions in revenues due to the popular nature of the drug. If you or a loved one has taken Bextra, an experienced attorney can inform you of your legal rights, identify all parties that may be liable for resulting injuries, and will be able to determine the best way to proceed. Should a Bextra lawsuit be appropriate, your attorney will work closely with you to maximize any compensation award to which you are entitled.
