Bextra, Bextra! Read All About It! First trial to be heard in May

San Francisco, CANearly four years after Bextra was taken off the market for cardiovascular risk, the first Bextra trial is scheduled to be heard May 5th. On the heels of the mammoth $4.85 billion Vioxx settlement, the Multi-District Litigation (MDL) Court for the Bextra/Celebrex litigation is finally ramping up in California.

Bextra was only on the market for three years, but gained a significant toehold in the marketplace during its short, but troubled life. Prescriptions numbered into the millions, with sales exceeding $1.2 billion in only its second year of full availability.

Bextra was a pain medication made by Pfizer, and widely prescribed to treat the discomfort and symptoms of various forms of arthritis. The drug was also prescribed to women experiencing debilitating pain and cramping from menstrual cycles.

However, as much as Bextra proved an effective pain reliever, it quickly began presenting serious adverse affects. While Bextra was in the same class of drugs as the troubled Vioxx and Celebrex duo that came onto the market in 1999, Bextra was a second-generation Cox-2 inhibitor that did not come onto the market until three years later (it was approved by the US Food and Drug Administration (FDA) on November 16, 2001).

In similar fashion to the debacle that befell injured Vioxx patients, it appears that Bextra manufacturer Pfizer was aware of potential problems with Bextra well over a year before it was approved for entry into the marketplace. Specifically, it has been reported that a Coronary Artery Bypass Graft surgical study (CABG-1) from July of 2000—16 months before Bextra was given the green light—presented an increased risk of cardiovascular complication in high-risk patients.

When additional studies were found to reveal similar concerns, a further CABG study in 2004 confirmed the findings of the original CABG investigation, suggesting a significantly increased risk for heart attack and stroke in association with the use of Bextra in high-risk patients.

Not long after Merck pulled the troubled Vioxx from the market in the fall of 2004, the US Food and Drug Administration requested Pfizer do the same with Bextra, on April 7th 2005.

Immediately preceding the recall, the turn of events damning Bextra was fast and furious.

Following the second CABG study released in October of 2004, researchers at the University of Pennsylvania reported to the American Heart Association that patients taking Bextra exhibited more than twice the incidence of heart attack and stroke, than non-users.

Exactly a month later, the FDA fell in with a black box warning against using the medication for patients with cardiac problems. However, that caveat wasn't enough for HMO juggernaut Kaiser Permanente, which dumped Bextra on behalf of its 2.6 million Californian clients before the first month of 2005 was out.

In April, Bextra was gone, but certainly not forgotten by those who had suffered ill effects from using the medication. From a host of lawsuits that have been filed, the Bextra/Celebrex MDL court in San Francisco has indicated that it will require limited discovery from a group of 45 Bextra and Celebrex MDL cases. While only one case will be tried at a time, the presiding judge has indicated that he wants several cases ready to go by May 5th.

Anyone whose health may have been compromised by taking Bextra for pain would not be pleased to learn that Pfizer is said to have had early signs of trouble. In fact, a Pfizer clinician is said to have commented regarding the "Vioxx-like" safety profile of Bextra, when compared to Vioxx.

Such alleged disregard for patient health by bringing a potentially harmful product to market in spite of known, or suspected risk translates to an even greater bottleneck in the nation's courts.