Pfizer's Celebrex the cause of possible cardiovascular risks

Pfizer's Celebrex the cause of possible cardiovascular risks

But the company on Monday also said U.S. regulators had approved a new use for the drug, treating ankylosing spondylitis, a form of arthritis of the spine that Pfizer said affects more than 400,000 Americans.
Pfizer Inc. on Monday said the label of its Celebrex arthritis drug has been changed to add a prominent warning of possible cardiovascular risks, such as an increased chance of heart attacks, in line with new warnings on other arthritis and pain drugs.

The label will also carry a new warning that Celebrex, like older painkillers, can cause serious ulcers and gastrointestinal bleeding.

Celebrex was developed to treat pain with a far lower risk of such bleeding than older treatments. But in a large clinical trial, Celebrex failed to prove significantly safer for the stomach than a far cheaper standard painkiller.

Pfizer said the package insert label of the drug recommends it be prescribed "at the lowest effective dose for the shortest duration." But the company on Monday also said U.S. regulators had approved a new use for the drug, treating ankylosing spondylitis, a form of arthritis of the spine that Pfizer said affects more than 400,000 Americans.

"The fact that the FDA gave us a new indication shows they are confident in the safety of Celebrex," said Pfizer spokeswoman Mariann Caprino.

Celebrex has been one of the company's biggest products, though its sales have recently declined sharply due to safety concerns.

Second-quarter revenue from Celebrex plunged 45 percent to $401 million - one reason the world's largest drug maker expects a modest decline in company revenue this year.

A federal advisory panel of doctors in February said Celebrex "significantly" raised the risk of heart problems and strokes. But the advisers to the U.S. Food and Drug Administration recommended it remain on the market because of its benefits to arthritis patients.

Pfizer is adding the new "black box" warnings at the request of the FDA. The agency has also asked the makers of dozens of other prescription and non-prescription painkillers - including Motrin, Advil and Aleve - to strengthen warnings about possible heart risks and potentially life-threatening gastrointestinal bleeding.

The new warnings do not apply to aspirin.

New York-based Pfizer in April withdrew a similar arthritis drug, Bextra, after U.S. and European regulators said the risk of side effects, including a potentially fatal skin allergy, outweighed its benefits.

Pfizer last month said its sales forces was holding back on fully promoting Celebrex again until it knew the warning language the FDA would require on the drug's label.

Safety concerns about Celebrex and other painkillers intensified after Merck & Co. Inc. withdrew its Vioxx arthritis treatment in September when it was shown to double the risk of heart attack and stroke after long-term use.

Celebrex and Vioxx both work by selectively blocking an inflammation-causing protein called Cox-2; but in doing so, some scientists believe the drugs also increase the risk of blood clots that cause heart attacks and stroke.

Pfizer shares were up 23 cents to $26.73 in afternoon trading on the New York Stock Exchange, in line with gains for the drug sector.