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drug_recall celebrexPfizer Inc., the world''s largest pharmaceutical company, launched its arthritis painkiller drug Celebrex in 1999. Part of a class of drugs called COX-2 inhibitors, the drugs work by selectively blocking a protein called COX-2 that has been linked to inflammation. Quickly, Celebrex, and its rival Merck & Co.''s Vioxx that was released the same year, became top-selling, blockbuster drugs.
Since its 1999 introduction to the market, more than 27million people in the U.S. have been prescribed Celebrex and an estimated 75 million people worldwide for people suffering from arthritis and other pain. It has become the most-prescribed drug for treating arthritis and has been a financial success for Pfizer, with Celebrex providing annual sales of $2.7 billion for the drug giant.
At the end of September 2004, Merck & Co. announced, in the midst of controversy, that it was withdrawing Vioxx from the market after a study found the drug created double the risk of heart attacks and stroke in patients taking the drug for 18 months or longer. The Vioxx recall was the biggest prescription drug recall of all time, and regulators in the U.S. and Europe have been taking a closer look at the COX-2 class of painkillers ever since. The only remaining COX-2 drugs on the market after Vioxx was recalled were Pfizer''s Celebrex and Bextra.
Pfizer Chief Executive Officer Hank McKinnel said as recently as December 6, 2004 that there was no evidence Celebrex was dangerous. Celebrex was believed to be a safer alternative to Vioxx, and in the months since Vioxx was recalled Celebrex sales have jumped. In the first full month of data after the Vioxx recall, in October 2004, sales of Celebrex topped $260 million, or 63.5 percent of the market for COX-2 inhibitors, according to IMS Health. In September 2004, Celebrex had accounted for 48.7 percent of the market for new generation painkillers.
December 17, 2004, Pfizer announced a government-sponsored trial of Celebrex was halted after patients taking the medicine had more than twice as many heart attacks as patients taking a placebo. Immediately, stocks dropped in very heavy trading as new concerns about pharmaceuticals were made. The Celebrex heart attack risks could mean major trouble for Pfizer.
After the Vioxx recall, Merck has been in the midst of a financial and public relations disaster. The company was accused of suppressing news about the drug''s side effects and its legal liabilities are estimated at up to $18 billion, with its shares dropping by nearly one third in the ten weeks since the Vioxx recall. In the first nine months of 2004 ending September 30, worldwide sales of Celebrex more than doubled from the same period a year prior to $2.29 billion, accounting for six percent of Pfizer''s total income of $37.59 billion.
Public Citizen consumer group has been preparing a petition asking the FDA to take Celebrex and Bextra off the market. In the beginning of December 2004, Pfizer already said its other COX-2 drug Bextra is linked to an elevated risk of blood clots and heart attacks and strokes in cardiac surgery patients. According to the director of Public Citizen, Sidney Wolfe, “They should come off the market and our petition will be filed in the next several weeks to ban both of these drugs.”
Experts do not know why Celebrex and Vioxx may raise the risk of heart attack or stroke. Celebrex is the 10-th most popular drug in the U.S., but the new Celebrex safety concerns could have devastating results for Pfizer.
After COX-2 painkillers – Vioxx, Celebrex and Bextra- came under scrutiny when cardiovascular risks were associated to the drugs some drugmakers saw this as an opportunity to try to capitalize on the events.
Vioxx went off the market in Se...
Merck & Co. and Pfizer Inc. have been criticized for their aggressive marketing campaigns for its COX-2 drugs, putting scrutiny on pharmaceutical advertising as a whole. Between December 2003 and November 2004, pharmaceutical ad spending increased 30...
A three-day FDA Advisory Committee meeting has wrapped, but the COX-2 drugs controversy is still not resolved. Although the panel of government medical experts advised keeping the drugs, including Pfizer Inc.’s Celebrex and Bextra, on the market, new...
Celebrex Warning - Celebrex timeline