Our Practice Areas : Injury Law : Bextra

HAVE YOU BEEN HARMED BY BEXTRA?

Published studies indicate a link between Bextra and serious heart and skin problems. After concluding that the overall risk versus benefit profile was unfavorable, the FDA requested that Pfizer Inc. voluntarily withdraw Bextra (valdecoxib) from the market. Pfizer did so on April 7, 2005, and issued this statement:  “For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options.”

The Ziff Law Firm is a team of legal professionals that has provided skilled, aggressive and ethical legal services to residents of New York and Pennsylvania for more than 50 years. We created this page about Bextra to help answer any questions you may have about the drug. If after reviewing this page you feel you may have a pharmaceutical negligence claim against Pfizer because you or a loved one suffered serious heart or skin problems, please contact us at 607-733-8866 and we will be happy to review your case.

BACKGROUND INFORMATION
Pfizer Inc., the world’s largest drugmaker, pulled Bextra from U.S. and European pharmacies because the Food and Drug Administration found that the risks posed by the drug outweighed its benefits.

Bextra is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It is also a COX-2 inhibitor like Vioxx, Merck & Co.’s blockbuster arthritis drug that was voluntarily withdrawn from the market in September 2004 because of its link to increased heart attack risk.

Both Vioxx and Bextra worked by reducing substances in the body that cause inflammation, pain, and fever, and were prescribed to patients to relieve the pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra was also used to treat painful menstruation.

However, the drug was also known to induce life-threatening skin and hypersensitivity reactions, conditions that appear in the form of inflammation of the mucous membranes of the mouth, throat, genitals, intestinal tract, and membrane lining the eyelids. This skin disorder is called Stevens-Johnson syndrome, and can lead to lesions and blisters causing intense pain and even death from infection.

The FDA based its request that Bextra be withdrawn on:

  • The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery trials that the FDA believed may be relevant to chronic use.
  • Reports of serious skin reactions, including the aforementioned Stevens-Johnson syndrome.
  • Lack of any demonstrated advantages for Bextra compared with other NSAIDs.

Before concluding that the risks of using Bextra outweighed its benefits, the FDA required the drug carry a “black box” warning on its label, since Bextra was found to trigger Stevens-Johnson syndrome far more often than any other drug. Other serious, side effects associated with Bextra:

  • 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

The FDA also asked manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling for their products to include a boxed warning and a medication guide

THE ZIFF LAW FIRM CAN HELP!
If you have taken Bextra and experienced any of its side effects, contact the attorneys of the Ziff Law Firm to discuss your dangerous drugs claim immediately. We will help guide you through the legal process.

At the Ziff Law Firm, we recognize the deep trust placed in us by our clients, and we strive to uphold that trust by working hard and fighting hard for our clients. We do the best we possibly can for every client on every case. So, please call us at 607-733-8866 for your free legal consultation, or save time with our online Contact Form.