Pfizer takes painkiller Bextra off market, FDA wants warnings on others
language=JavaScript> </SCRIPT>
<IFRAME border=0 marginWidth=0 marginHeight=0 src="http://ad.doubleclick.net/adi/sports.peoplepc.dart/sports_home_sky;sz=120x600;ptile=2;ord=85036168??" frameBorder=no width=120 scrolling=no height=600>
</IFRAME>
Thursday, April 7, 2005 WASHINGTON - The painkiller Bextra was taken off the market Thursday, and the government wants other drugs in the same class to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them.
Pfizer Inc. suspended sales of Bextra in the United States and the European Union at the request of the Food and Drug Administration and European regulators. The company said that the FDA, in seeking Bextra's withdrawal, cited a risk of serious skin reactions to Bextra on top of the risks shared by other similar drugs.
Pfizer shares dropped 62 cents, or 2.3 percent, to $26.24 in morning trading on the New York Stock Exchange. They have traded in a range of $21.99 and $37.90 over the past 52 weeks.
The boxed warning recommended for the other non-steroidal anti-inflammatory prescription drugs is the strongest available to the FDA.
In addition to the prescription drugs, the FDA asked manufacturers of related over-the-counter painkillers such as Advil and Motrin to revise their labels to include information about the risks of cardiovascular incidents and gastrointestinal bleeding.
"Today's actions protect and advance the health of the millions of Americans who rely on these drugs every day," said Dr. Steven K. Galson, acting director of FDA's Center for Drug Evaluation and Research.
The risks posed by Bextra outweigh its benefits, the FDA said.
The FDA has been studying the safety of the so-called Cox-2 inhibitors since Merck & Co. voluntarily pulled Vioxx from the market Sept. 30 after heart problems were reported in some users. Once blockbuster sellers, the painkillers were particularly popular among arthritis sufferers.
"For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options," Pfizer said in a statement Thursday.
Pfizer said it planned further discussions with the FDA about the possibility of returning Bextra to the market.
"Pfizer respectfully disagrees with FDA's position regarding the overall risk-benefit profile of Bextra," the company said.
In February, advisers to the FDA had recommended that people who depend on Pfizer's Celebrex and Bextra and Merck's Vioxx be allowed to continue to use them despite the health risks.
The panel said Vioxx posed the greatest risk and that Celebrex had the fewest side effects. It recommended that the prescription drugs carry strong warnings and that more study be done to get a better understanding about the drugs.
In a statement, Merck said Thursday that while it respects the FDA's decision on selective Cox-2 inhibitors, "It is important to recognize that the millions of patients who continue to suffer with pain need effective therapies and selective Cox-2 inhibitors have provided important therapeutic benefits to patients. We look forward to discussions with the FDA."
Janet Skidmore, a spokeswoman for the Whitehouse Station, N.J.-based company, said the company had no immediate comment on whether the Bextra decision would influence any consideration to bring Vioxx back, or whether it will continue to seek approval for Arcoxia, a planned successor to Vioxx.
Merck shares fell 42 cents, or 1.3 percent, to $32.47 in morning trading on the NYSE, but are above their 52-week low of $25.60 reached in November.
The FDA's move is a significant blow for New York-based Pfizer which had just announced a plan to return to double digit earnings growth by next year, in part by reviving sales from Bextra and Celebrex.
Sales of both drugs went into a freefall last year after being linked to heart problems. Last year, Celebrex sales totaled $3.3 billion while Bextra sales were $1.3 billion. Analysts had been expecting sales of both drugs to sink this year because of safety concerns but now the situation is even worse than previously anticipated.
Pfizer will lose the vast majority of its Bextra sales for the year but Celebrex sales will take a huge hit as doctors and patients question the safety of the only remaining Cox-2 inhibitor on the market.
"If you are a doctor looking at this, how can you think there are problems with two and not the third," said Jason Napodano, an analyst with Zacks Investment Research.
Napodano had expected Celebrex sales of $2 billion but they could be slashed to only $1 billion. He expected Bextra revenue of $605 million but most of that has just evaporated.
He believes the FDA decision will shave at least 5 cents from Pfizer earnings this year.
Pfizer also announced $4 billion in cost cuts as part of its turnaround. Napodano said the company will have to make more cuts if it wants to met its goal of returning to double-digit growth.
Napodano never believed that Vioxx would return to the market so he doesn't view the FDA decision as having any implication for Merck.
---
AP Business Writer Theresa Agovino in New York contributed to this story.
---
On the Net:
Food and Drug Administration: http://www.fda.gov/cder/drug/infopage/cox2/default.htm