March 2002—Pharmacia begins marketing Bextra.
July 2002—Pfizer buys Pharmacia for $58 billion; approval by Federal Trade Commission does not come until April 2003.
October 22, 2002—European Medicines Evaluation Agency (the FDA’s European equivalent) issues a public statement warning about Bextra side effects.
November 13, 2002—Pharmacia issues “dear doctor” letter about Bextra.
November 15, 2002—FDA announces that it has received about 20 reports of serious reactions to Bextra , including skin diseases and hypersensitivity reactions.
December 2002—Lawsuit filed against Pharmacia for off-label marketing of Bextra.
May 19, 2003—Bextra approved for sale in all 15 countries of the European Union.
November 2003—Year-long analysis by Knight-Ridder reveals that more than half of all Bextra prescriptions are for off-label uses.
February 2004—FDA panel concludes that all COX-2 inhibitors pose cardiovascular problems but should be available to consumers.
September 2004—Merck pulls Vioxx from the market, citing an increased risk of heart problems. Many patients immediately switch to Bextra or Celebrex, assuming or hoping that they are safe. Recent studies and reports, however, show this not to be the case.
October 15, 2004—Pfizer announces the results of two trials that point to an increased cardiovascular risk for patients taking Bextra. It is later learned that the company has been sitting on this information for two months.
November 9, 2004—A study (combining data from 5,930 patients in 12 trials) presented before the American Heart Association finds that Bextra more than doubles patients’ risk of heart attack and stroke. Dr. Garret FitzGerald, a leading expert on COX-2 drugs, says that the results underscore Bextra’s dangers: “The magnitude of the signal with Bextra is even higher than what we saw in Vioxx. This is a time bomb waiting to go off.”
November 16, 2004—Pfizer is hit by a lawsuit alleging that Bextra was responsible for the death of a 46-year-old New Jersey man who used the drug for nine months.
November 18, 2004—At a Senate hearing, Dr. David Graham of the FDA puts Bextra on his list of the five most dangerous drugs on the market.
December 6, 2004—Pfizer CEO Hank McKinnell says that even if studies show definitive proof of cardiovascular risk, he might not withdraw Bextra.
December 9, 2004—FDA orders a “black-box” warning on Bextra labels, cautioning that it should not be taken by patients undergoing heart bypass surgery. The agency also strengthens warnings about the risk of serious, potentially fatal skin reactions to Bextra.
April 7, 2005—Pfizer withdraws Bextra from the market at the request of the FDA, which says it carries risk of heart attack, stroke and fatal skin reactions.