Drugmaker Pfizer Under Pressure on Bextra

November 8, 2004

Mon Nov 8, 2004 11:26 AM ET

CHICAGO (Reuters) - Drugmaker Pfizer Inc. is in talks with regulators over a

likely change to arthritis drug Bextra's label to carry a strict warning

alerting doctors of the risk of a potentially deadly skin reaction, the

company said in a regulatory filing.

Pfizer, whose shares fell nearly 3 percent Monday morning, also said in the

filing it is under investigation by New York and Connecticut in connection

with potentially improper promotion of drugs for uses other than those

approved by U.S. regulators.

Pfizer also said it has initiated an internal probe relating to its sales

operations in Croatia.

A Pfizer spokesman declined to comment on the investigation or its talks

with the U.S. Food and Drug Administration over Bextra.

Prudential Securities analyst Tim said the warning on Bextra, which

is in the same class of drugs as Pfizer's Celebrex and Merck & Co.'s

withdrawn arthritis drug Vioxx, suggests the commercial future of Bextra is

at risk.

Pfizer said it is talking to regulators about carrying a " black box " warning

that it might result in a rare, but sometimes fatal skin disorder called

s- syndrome.

Launched in 2001, Bextra had sales last year of $687 million.

In the New York investigation, Pfizer said it has received a letter from

Attorney General Eliot Spitzer's office requesting documents and information

on clinical trials of certain drugs for uses other than those approved by

the U.S. Food and Drug Administration. Pfizer said the probe involved the

possible promotion of products for unapproved uses.

Pfizer said it received a letter from the Office of the Attorney General of

the State of Connecticut requesting similar materials concerning its

antidepressant Zoloft.

Pfizer spokesman Fitzhenry said both investigations were new, but

declined to specify which drugs the New York attorney general was

investigating. A spokesman for Spitzer's office declined to comment.

Pfizer also said it has voluntarily provided the Department of Justice and

the Securities and Exchange Commission with information regarding an

internal probe of certain potentially improper payments made in connection

with foreign sales activities in Croatia.

Pfizer's shares fell 79 cents to $28.00 Monday on the New York Stock

Exchange.

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