Why Bextra Was Withdrawn From The Market

Bextra was withdrawn from the market by Pfizer pending further discussions with the FDA. Potential adverse reactions to the drug were found to far outweigh the benefits. Bextra, generically known as Valedocoxib, is a non-steroidal anti- inflammatory NSAID drug used for management of inflammation, stiffness and the pain of osteoarthritis, adult rheumatoid arthritis and painful menstruation.

Long term use of Bextra led to adverse cardiovascular problems, including heart attack and stroke. Even potentially life-threatening skin reactions have been associated with this drug.

Manufactured by Pfizer, Bextra is a relatively new class of NSAID known as COX-2 inhibitor. It acts as a good arthritis pain-relief medication without affecting the stomach lining. While Bextra proved to be effective in pain management, it was found to have some very dangerous side effects.

Studies have shown that Bextra increased the risk of heart attack in patients who had recently undergone a Coronary Artery Bypass Graft Surgery, CABG. Severe skin reactions such as Steven-Johnson Syndrome and toxic epidermal necrosis were also reported as potential side effects. Some of these skin afflictions became fatal, calling into question the benefit and risk potential of this drug.

Usually, these reactions happen within two weeks of starting Bextra therapy but it can also happen any time during the period of treatment with this drug. Patients with or without a history of allergy to sulfur medications also reported these reactions. Symptoms usually include rashes, hives, itching, breathing difficulty, swelling of lips, tongue and face and other related symptoms of allergic reactions.

Some patients on Bextra also complained of abdominal pain, tenderness or discomfort, vomiting tendencies include blood vomiting, black stools, edema, yellowing of the skin and flu like symptoms. These were the forerunners of more dangerous consequences to follow. There was not enough clinical research data to explain these side effects. Instead of giving relief to the patients, the drug brought them even more misery and to some, even death.

Considering these potential threats, Pfizer was compelled to withdraw Bextra from the market pending further investigations and trials. Patients on Bextra were advised to contact their healthcare providers for alternate medications.

The decision was made to review the drug's safety data compiled during clinical trials and post marketing reports before making a final decision on complete Bextra withdrawal.

Taking stock of the situation and incoming reports, on April 7, 2005, the FDA asked Pfizer to withdraw Bextra in a voluntary recall as the risks of cardiovascular problems and life-threatening skin reactions were found to outweigh the benefits of the severe pain management in arthritis and other inflammatory disorders. After studying the data provided by Pfizer, the FDA concluded that, though the cardiovascular risks with Bextra are similar to other equivalent category NSAIDS, the possibility of life-threatening skin reactions essentially necessitate the complete withdrawal of Bextra from the market.

Disclaimer – The information presented here should not be interpreted as or substituted for medical advice. Please talk to a qualified professional for more information about Bextra.