BEXTRA Pfizer likely to include warning on painkiller

Pfizer warned doctors of the drug's side effects last month.
DOW JONES NEWSWIRES
NEW YORK -- Pfizer Inc. is likely to add a so-called "black box" warning to the label of its painkiller Bextra, which is similar to the recently pulled Vioxx, because it sometimes leads to a serious skin reaction.
Pfizer made the announcement in its most recent quarterly report, filed with the Securities and Exchange Commission on Friday. A black-box warning is the strongest warning available for prescription drugs.
The drug has in a few cases caused Stevens Johnson syndrome, which occurs when the immune system turns on itself to rid itself of a drug, in effect burning the patient from the inside out.
It leads to severe, painful blistering of the mucous membranes and skin, according to Jean Farrell-McCawley, founder of the Stevens Johnson Syndrome Foundation. In many patients, their skin actually starts coming off in sheets, she said.
"The people are usually hospitalized in a burn unit," she said, adding that many have to be put on feeding tubes and ventilators. Stevens Johnson has about a 30 percent mortality rate, she said.
Warning to doctors
Pfizer had sent out a letter to doctors in mid-October warning them about the side effect, saying that the skin rashes have led to hospitalizations and deaths in a small number of patients. The risk is greatest during the first two weeks the drug is taken.
Bextra's label has included information about the skin reaction since 2002, Pfizer said.
Bextra is a so-called Cox-2 inhibitor, along with Pfizer's Celebrex and Merck & amp; Co.'s Vioxx, which was pulled from the market in September because of cardiovascular side effects.
Prudential analyst Timothy Anderson wrote in a Friday research note that he expects Bextra to reach $1.7 billion in 2005 sales, contributing 15 cents a share to Pfizer's bottom line next year. But between this new warning and a "signal" of cardiovascular toxicity, this forecast may have to be revised downward, he wrote.
The skin reaction is included as a warning on the packages of many drugs on the market, but "few, however, have black box warnings," Anderson said.