Contact A Lawyer
Near You

Contact us today for a complimentary consultation with a qualified attorney near you.

Bextra and Blood Clots

In two studies that appeared in the January 17, 2005 issue of Circulation: Journal of the American Heart Association , researchers suggested combining Pfizer Inc.'s painkiller Bextra with aspirin might increase blood clot risk. At the time of the study a similar drug, Vioxx, had been removed from the market just months earlier because of increased risks of heart attacks and strokes, and a third drug in the same Cox-2 inhibitor family, Celebrex, was also linked to increased cardiovascular effects.

In the first study researchers studied the effects of Bextra and aspirin on the hardening of the arteries in mice that were prone to the condition, and they found that low-dose aspirin slowed the development but it appeared ineffective once the disease was established. The addition of a Cox-2 inhibitor like Bextra failed to enhance aspirin's benefits, and researchers were shocked to discover a Bextra and blood clots risk instead.

The Bextra and blood clots risk, according to researchers, appeared to occur when the Cox-2 and aspirin combination produced potentially dangerous changes in the makeup of the plaque within the arteries. Since aspirin protects against hardening of the arteries by blocking Cox-1, the researchers believed adding a Cox-2 shifted the balance in favor of the Cox-1 enzyme, creating the increased risk of developing dangerous Bextra and blood clots cases that could lead to a heart attack or stroke.

A couple months earlier, Pfizer had submitted a study to the FDA in November 2004 including 1,500 patients treated with Bextra after undergoing coronary artery bypass graft, and it showed increased Bextra and blood clots risks in the legs and in the lungs of the patients who took Bextra compared to patients treated with a placebo. First FDA approved in November 2001, safety concerns have surrounded Cox-2 drugs ever since Vioxx and Celebrex first emerged in 1999.

In December 2004, amidst major controversy in the wake of the Vioxx recall and questions regarding the safety of the entire class of drugs, the VP and Medical Director of Pfizer Canada issued a "Dear health care professional" letter, warning doctors of the Bextra and blood clots, cardiovascular, deep surgical infection or sternal wound complications. In the U.S., the FDA advised patients not to change their treatment plans without first consulting with their physician, but added a new warning to Bextra stating it should be avoided by patients undergoing heart bypass surgery.

After links to increased risks of Bextra and blood clots leading to cardiovascular problems, a rare and potentially deadly skin disease called Stevens-Johnson Syndrome and coronary artery bypass surgery infections and sternal wound complications, the FDA finally forced Pfizer to pull the drug off the market. Following the major drug recalls, a nationwide survey by Pri-Med Institute revealed fewer than one in five primary care physicians say they plan on prescribing a Cox-2 inhibitor for treating chronic pain.

Although Cox-2 drugs like Bextra were designed to be easier on the stomach, research continued to link safety problems to the drugs and indicated the newer drugs were not as beneficial as they were touted. By the time the studies linking Bextra and blood clots risks emerged, the reputation of Cox-2 drugs had taken a seemingly irreversible turn for the worse, forcing regulators to look closer at drug safety issues as a whole.

For more information on Bextra and blood clots risks, please contact us to confer with an attorney.

Contact a Bextra Recall Lawyer

More Bextra Resources

Bextra Consumer Information - Patient FAQ on Bextra, including side effects, warnings and drug information from the FDA.