What is Bextra / Valdecoxib?
Bextra (valdecoxib) is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It is a Cox-2 inhibitor, meaning that Bextra works by inhibiting cyclooxygenase enzymes that induce inflammation and pain in patients.

Bextra was introduced to the market with FDA approval as a treatment for osteoarthritis, acute pain management, menstrual symptoms, and relief from the symptoms of rheumatoid arthritis in both adults and children.

Why was Bextra withdrawn from the market?
The pharmaceutical manufacturer Pfizer voluntarily removed Bextra from the prescription drug market (April 7, 2005) following a request from the FDA (Food & Drug Administration) that sales of the medication be stopped.

The FDA request was made following analysis of additional studies and information that show an increased risk of cardiovascular events and gastrointestinal bleeding associated with the use of Bextra. The FDA has also cited serious and sometimes life threatening skin reactions, including Stevens Johnson Syndrome.

What are some of the side effects of Bextra?
In addition to the very serious, sometimes life threatening, side effects of increased risk of heart attacks, cardiovascular events and gastrointestinal bleeding, Bextra side effects may include:

• Abdominal pain, tenderness, or discomfort
• Bloody, black, or tarry stools
• Nausea or heartburn
• Bloody vomit
• Unexplained weight gain
• Swelling or water retention
• Unusual fatigue or lethargy
• Yellowing of the skin or eyes
• Flu-like symptoms
• Unusual bruising or bleeding

Why didn't the FDA also recommend that Celebrex be withdrawn?
The FDA has released the following statement regarding their NSAID recommendations:

"The Advisory Committees were unanimous in their conclusion that an increased risk of CV adverse events has been demonstrated for Celebrex (as for all the Cox-2 selective inhibitors) but strongly supported the continued marketing of the drug. FDA has concluded, based on the available data, that the benefits of Celebrex outweigh its potential risks in properly selected and informed patients. This conclusion is based on our review of the available safety data and the long-term controlled clinical trial comparisons of Celebrex to non-selective NSAIDs. While it appears that Celebrex is associated with an increased risk of serious CV adverse events, the available data do not support a conclusion that Celebrex is significantly worse than the non-selective NSAIDs. The NSAID class boxed warning regarding increased CV and GI risks will be applied to Celebrex, and in addition the labeling will include additional information as described in question 2 above that will inform physicians and patients of the potential risks and allow for informed prescribing decisions."

What types of patients are at the highest risk for dangerous Bextra side effects?
Those at higher risk would include patients immediately post-operative from cardiovascular bypass surgery (CABG) and people who have coronary artery disease (people who have known angina or who have had a heart attack), people who have cerebrovascular disease (people who have had a stroke or who currently have episodes known as TIA (transient ischemic attacks)), and people with a history of stomach ulcers.

What is Stevens Johnson Syndrome?
Stevens Johnson Syndrome (SJS) is a rare, life-threatening reaction to medication – one of the most devastating of all adverse drug reactions. SJS has been linked to the use of the painkiller Bextra, manufactured by Pfizer, Inc., and Arava, manufactured by Aventis. Both drugs are used to treat rheumatoid arthritis.

Stevens Johnson Syndrome is characterized by inflammation of the mucous membranes of the mouth, throat, eyes, genital tract and intestinal tract. Ulcers inside the mouth are the most common, causing inflammation and irritation to the tongue, gums, and lips and can extend into the throat. Affected individuals may also have skin lesions, blisters and bleeding in the lips, eyes, mouth, nasal passage and genital areas.

As SJS evolves, the skin literally sloughs off in sheets. Patients are typically treated in a hospital’s burn unit. If the skin lesions become infected, or the patient develops lesions in the lungs, it can cause death.

What should I do if I am currently taking Bextra?
You should immediately contact your doctor to discuss alternative medication. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs.

If you have been injured by Bextra or any other dangerous prescription drug, the manufacturer may have failed in its duty to design, make, inspect and label the product appropriately.

Contact our experienced injury attorneys today for a FREE claim evaluation. Contact Us Online, or call Toll Free: 866-991-4700

Bextra Lawyers - Our Bextra Website including Prescription Drug Recall and Side Effects information for Bextra.

Call Brown & Crouppen at Toll-Free: 866-991-4700 for your free
legal consultation or save time with our online Contact Form.

Toll-Free: 866-991-4700