BEXTRA®: HEART ATTACKS, STROKES AND OTHER SIDE EFFECTS

On the heels of the recall of Vioxx® in September 2004, results of a study were issued to the American Heart Association on November 9, 2004 linking Bextra® to heart attacks. In April 2005, Bextra® was taken off the market.

Bextra® (valdecoxib), manufactured by Pfizer Inc., is a widely prescribed prescription arthritis pain medication in the United States. It is part of a class of pain medications known as Cox-2 inhibitors, of which there are three in total. Vioxx®, one of the two Cox-2 inhibitors, was withdrawn from the market on September 30, 2004 due to a study linking this pharmaceutical to heart attacks and strokes. On December17, 2004, Pfizer Inc. announced that a study of Celebrex, the other remaining Cox-2 inhibitor, showed that patients taking the drug daily had an approximately 2.5 fold increase in their risk of experiencing a major cardiovascular event.

On December 9, 2004, The Food and Drug Administration (FDA) announced that a “black box” warning needed to be placed on all packages and labels of Bextra®. The new boxed warning in the label stated that patients taking Bextra® have reported serious, potentially fatal skin reactions, including Steve-Johnson Syndrome and toxic epidermal necrolysis. In addition to highlighting serious skin reactions, the strengthened label warnings also highlighted new data about cardiovascular risks. A recently-completed study conducted by Pfizer, which included over 1,500 patients treated after CABG (cardiac bypass surgery), showed an increased cardiovascular risk in patients treated with Bextra compared to placebo. Observed cardiovascular events included thromboembolic events such as myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung).

On April 7, 2005 the FDA asked Pfizer, Inc. to withdraw Bextra® from the market. The FDA’s serious side effects, ranging from stomach bleeding, stomach ulcers, intestinal bleeding, heard complications, and even death. However, Vioxx® (and its competitors Celebrex® and Bextra®) claimed to successfully treat pain without such drawbacks. But as a recent study put forth by Merck & Co attests, this just isn’t the case. In fact, Vioxx® users are believed to be twice as likely as nonusers to suffer strokes, heart attacks, and blood clots and are still susceptible to other health ailments, ranging from kidney damage to hypertension.

The American Heart Association study, which consisted of approximately 6,000 patients taking part in 12 trials, found that the incidence of heart attacks and strokes among patients take Bextra® was more than TWICE those given placebos.

COX-2 inhibitors are a class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that relieve pain and inflammation by blocking COX-2 enzymes in the body. Vioxx® falls into this category. NSAIDs were created for people who cannot take traditional NSAIDs, which can cause stomach ulcers and bleeding in some patients. Traditional NSAIDs, such as ibuprofene and aspirin, block both COX-2 and COX-1 enzymes. Because COX-1 enzyme protects the lining of the stomach, blocking it can lead to stomach irritation. It is believed that COX-2 inhibitors (including Vioxx®) reduce the incidence of stomach ulcers and bleeding because they do not block COX-1 enzymes.

Bextra, also known as valdecoxib, was approved by the FDA on November 2001 and went to market in March 2002. Bextra is made by Pharmacia/Pfizer.

Bextra® is taken once daily. It is classified as a COX-2 inhibitor, part of a group of non-steroidal anti-inflammatory medications (NSAIDs). COX-2 inhibitors block one of the enzymes which causes pain and inflammation; other similar drugs include Vioxx® and Celebrex®.

Bextra® is prescribed for the relief of symptoms of:

• osteoarthritis
• adult rheumatoid arthritis
• severe menstrual cramping