Celebrex - new information

lsyorke, RN · Dec 17, 2004

http://www.nytimes.com/aponline/business/17wire-pfizer.html?hp&ex=1103346000&en=d05ee1ac705a1176&ei=5094&partner=homepage

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December 17, 2004

Pfizer Says Painkiller Tied to Increased Risk of Heart Attack

By THE ASSOCIATED PRESS

Filed at 10:40 a.m. ET

NEW YORK (AP) -- Pfizer Inc. says it has found an increased risk of heart

attacks with patients taking its top-selling painkiller Celebrex, a drug

that is in the same class as Vioxx, which was pulled from the market in

September because of safety concerns.

Pfizer announced Friday that it found the increased risk in one of two

long-term cancer prevention trials, while the other trial showed no

increased risk.

The National Cancer Institute, which was conducting the study for Pfizer,

suspended the use of Celebrex after finding that patients taking 400mg to

800mg of the drug daily were found to have a risk of 2.5 times greater of

experiencing major heart problems than those who weren't. A separate cancer

study found no increased heart risk with patients taking 400mg of Celebrex

per day.

Pfizer was conducting the trials as part of an effort to find a new

application for the drug.

The news sent the stock of the giant pharmaceutical maker plunging in

morning trading on the New York Stock Exchange, where its shares were down

$4.14, or more than 14 percent, at $24.84 in heavy volume.

Both Celebrex and Vioxx, which is made by Merck & Co., are a type of drug

called cox-2 inhibitors, which have become popular because of their

effectiveness in treating the pain of arthritis and other ailments.

Celebrex is the most-prescribed drug for treating arthritis. In the nine

months ending in September, worldwide sales of Celebrex more than doubled

from the same period a year earlier to $2.29 billion, accounting for 6

percent of Pfizer's total income of $37.59 billion.

Pfizer did not indicate that it was withdrawing Celebrex from the

marketplace.

The withdrawal of Vioxx has been a financial and public relations disaster

for Merck. Its legal liabilities are estimated at up to $18 billion, and its

shares have dropped by nearly one-third since the recall announcement was

made in late September.

Vioxx had been a blockbuster drug for Merck, it's No. 2 earner with annual

global sales of $2.5 billion, amounting to 11 percent of the company's

$22.49 billion in revenue last year. Some 2 million people worldwide had

been taking Vioxx.

Dr. Joseph Feczko, president of worldwide development for Pfizer, noted that

the results in the trial finding increased risk of heart attacks were not

consistent with either the other cancer prevention trial or with a ``large

body of data'' that the company had collected.

``Pfizer is taking immediate steps to fully understand the results and

rapidly communicate new information to regulators, physicians and patients

around the world,'' Pfizer's chief executive Hank McKinnell said in a

statement

Earlier this month, the Food and Drug Administration said it was adding a

warning to the labels of another Pfizer drug, Bextra, noting a risk of

potential heart problems associated with the use of Bextra in people who

have recently had heart bypass surgery. Bextra is also a cox-2 inhibitor

type of drug.