»  Bextra was first approved by the Food & Drug Administration (FDA) in November, 2001. Drug manufacturer Pfizer removed Bextra from the market, following a FDA request, on April 7, 2005.

»  Bextra was removed from the pharmaceutical market due to health risks and side effects that included greater risk of heart attacks, strokes, cardiovascular events and gastrointestinal bleeding in patients.

»  Each year approx. 100,000 people die and 2.1 million are seriously injured from adverse drug reactions.

»  In 2004 Pfizer recorded approximately $1.5 billion in Bextra sales.

»  It is estimated that 7 million patients have been prescribed Bextra.

»  Approx. 12.9 million prescriptions were written for Bextra in 2004. 

April 2000: FDA requires Merck to add information about serious side effects to Vioxx labeling.

November 16, 2001: FDA approves Bextra for treatment of arthritis, acute pain, and severe menstrual symptoms.

November 13, 2002: FDA and Bextra drug manufacturer (Pharmacia at the time) release new warnings and product labeling. The labeling is updated with new warnings following post marketing reports of serious adverse effects including life-threatening risks related to skin reactions.

July, 2004: FDA adds warning to Bextra label regarding possible serious skin reactions.

September 30, 2004: Merck recalls NSAID, COX-2 inhibitor Vioxx due to increased risk of heart attack and strokes in patients.

November, 2004: FDA scientist David Graham testifies before the U.S. Senate that health concerns regarding Bextra, and other like drugs, are not new.

"This drug could have been off the market two years ago," Graham said.

December 23, 2004: FDA issues a Public Health Advisory warning of the "increased risk of serious cardiovascular events", and advising doctors to limit the use of Bextra, Vioxx and Celebrex for at-risk patients. See the advisory, click here.

January 10, 2005: The Department of Health & Human Services sends drugmaker Pfizer a warning label stating that specific 'Direct to Consumer' (DTC) marketing for Celebrex and Bextra "omit material facts, including the indication and risk information; ... make misleading safety, unsubstantiated superiority, and unsubstantiated effectiveness claims". Full Warning Letter

January 24, 2005: The nationwide consumer organization Public Citizen petitions the FDA to remove Bextra and Celebrex from the market because of their cardiovascular risks. See Full Petition

February, 2005: FDA Advisory Panel unanimously concluded that Bextra, Vioxx and Celebrex, all COX-2 inhibitors, significantly raise heart and stroke risk.

April 7, 2005: Pfizer halts sales of Bextra based on FDA recommendations. FDA finds that health risks associated with Bextra outweigh prescription's benefits.

If you are 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 the manufacturer may have failed in its duty to design, make, inspect and label the product appropriately.

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