| Pfizer Suspends Bextra, Agrees to Warning on Celebrex
By Nicole Ostrow
April 7 (Bloomberg) -- Pfizer Inc., the world's biggest drugmaker, suspended sales of the Bextra painkiller at the request of U.S. regulators and agreed to apply the government's strictest warnings to its similar Celebrex drug.
The moves come six months after Merck & Co. withdrew its related pain drug Vioxx because a company study linked it to an elevated risk of heart attacks and strokes. Bextra, which was also tied to a rare, fatal skin disorder, generated $1.29 billion, or 2.4 percent, of New York-based Pfizer's revenue last year. Celebrex brought in $3.3 billion, or 6.3 percent.
Pfizer said it disagreed with the Food and Drug Administration's finding that Bextra should be withdrawn. The FDA went against the advice of a panel of doctors and scientists at a February hearing that Bextra's benefits outweighed its risks and should remain on the market.
``It would have been easy for the FDA to say, `We're following the advice from the advisory committee,''' and permit Bextra sales to continue, said Curt Furberg, an epidemiologist at Wake Forest University in Winston-Salem, North Carolina, who was a member of the FDA panel. ``But they went against Pfizer. Pfizer was against pulling the drug but had to agree.''
Shares of Pfizer fell 38 cents, or 1.4 percent, to $26.48 at 11:41 a.m. in New York Stock Exchange composite trading. Before today, they had fallen 25 percent in the past year.
Effect on Profit
``It's never good when a company has to pull a drug, but Bextra won't have that much effect on profit,'' said Hanne Leth Hillman, who helps manage $9 billion of stock at Bankinvest in Copenhagen and holds Pfizer shares. ``I would have been a lot more worried if they pulled a drug like Lipitor,'' Pfizer's $10.9 billion-a-year cholesterol pill, the world's best-selling drug.
More than 27 million people in the U.S. have been prescribed Celebrex since 1999 and more than 7 million have used Bextra worldwide since 2002.
Celebrex, Bextra and Vioxx are part of a class of drugs known as Cox-2 inhibitors. The medicines are designed to target the body's production of the Cox-2 enzyme, linked to pain and swelling, while sparing a related enzyme that helps protect the stomach from complications such as ulcers and bleeding. They sold for as much as $2 a pill, compared with pennies for generic painkillers such as aspirin.
Pfizer must add a warning highlighted in a black box to the label of Celebrex, the world's best-selling arthritis medication. The FDA said the warning would include increased risk of ``cardiovascular events and gastrointestinal bleeding.''
Nonprescription Drugs
Older, nonprescription painkillers such as ibuprofen will have to carry similar cautions, the agency said. Aspirin won't have such a warning because it has been shown to protect against heart attacks, the FDA said.
Pfizer said in a statement that it disagrees with the FDA's decision and will hold talks with the agency about returning Bextra to the market. In the meantime, Pfizer said it will suspend sales of Bextra in the European Union. Patients should stop taking Bextra and contact their doctors, Pfizer said.
Bextra already carried a warning highlighted in a black box on its label about its link to skin reactions, including Stevens- Johnson, a potentially fatal disorder that may cause rash, blisters or red splotches. The FDA determined that the skin and cardiovascular risks together were enough to justify the drug's withdrawal.
``No added advantage and a special risk is what led us to the change with Bextra,'' Steve Galson, acting director of the FDA's center for drug evaluation and research, said on a conference call.
Comment on Vioxx
Merck voluntarily recalled Vioxx Sept. 30 after a company- funded study showed more than double the risk of heart attack and stroke in patients taking the painkiller compared with those on a placebo.
At its three-day hearing into painkiller safety in February, the FDA panel found that Celebrex, Bextra and Vioxx all posed some level of cardiovascular risk. A majority of the 32 doctors and scientists also voted to recommend that the Pfizer drugs remain on the market. By a narrower margin, they agreed Vioxx could be sold again should Merck decide to bring it back. Merck didn't rule out a resumption of sales in testimony before the panel on Feb. 16.
The FDA said today that it will ``carefully review'' any proposal from Whitehouse Station, New Jersey-based Merck to resume sales of Vioxx.
Merck won't get approval to bring back the Vioxx painkiller, some doctors said.
``It closes the door completely,'' Steven Nissen, a cardiologist at the Cleveland Clinic, said in an interview today. ``If you're going to take Bextra off the market, I would be shocked if Vioxx came back,'' said Nissen, who sat on the FDA's advisory panel reviewing the safety of the pain pills.
The Vioxx recall wiped $25 billion from Merck's market value in a single day.
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