TA, here we go again, same old same old:
Monsanto's Superaspirin Celebrex
Has Been Linked to Several Deaths
By ROCHELLE SHARPE
Staff Reporter of THE WALL STREET JOURNAL 4-20-99
WASHINGTON -- Monsanto Co.'s breakthrough superaspirin Celebrex,
touted as much safer than other pain killers, has been linked to 10 deaths
and 11 cases of gastrointestinal hemorrhages in its first three months on the
market, according to reports submitted to the Food and Drug
Administration.
Five of the 10 people who died suffered from gastrointestinal bleeding or
ulcers, the so-called adverse event reports said. Those fatalities included
four men, ranging in age from 45 to 88, and one 75-year-old woman. Of
the other deaths, two were attributed to heart attacks, one to drug
interaction and one to kidney disorder. No cause of death was given for
the other fatality.
Most of the 11 other cases of hemorrhages required hospitalization,
according to the reports, which The Wall Street Journal obtained through a
Freedom of Information Act request. And there were six other reports of
abdominal pain or swelling associated with Celebrex, the FDA said.
Celebrex, manufactured by Monsanto's G.D. Searle & Co. and on the
market for 13 weeks, is one of the nation's most prescribed new drugs.
Already, 2.5 million prescriptions have been dispensed, compared with the
record 2.7 million Viagra prescriptions in its first 13 weeks on the market.
Because of the huge volume of prescriptions, the FDA said it was difficult
to evaluate the significance of these reports.
"We won't be able to reach conclusions about its relative safety compared
to other painkillers until more research is done," said Robert DeLap,
director of an FDA office of drug evaluation. "Do we think there's a signal
that the product poses some special risk? No," not at the moment.
Public Citizen's health-research group, a Washington-based advocacy
organization, said the side effects sound disturbingly similar to those
associated with Meloxicam, a superaspirin marketed in Britain since 1996.
Clinical studies of that drug had shown no significant damage, but now the
drug carries warnings of the potential for severe gastrointestinal adverse
effects. In the drug's first 21 months, 1,339 adverse reactions were
reported to the government, including 549 gastrointestinal adverse effects.
Of those, five people died and 94 others suffered from ulcers, bleeding or
stomach perforations.
Searle officials said they continue to be excited about Celebrex. "We really
feel the drug is performing as expected. The safety profile is what we
would expect," said Steve Geis, the company's vice president for arthritis
clinical research.
Celebrex, the first in a new class of painkillers known as Cox-2 inhibitors,
is supposed to be safer than nonsteroidal painkillers such as American
Home Products' Advil. Known as NSAIDs, these painkillers have been
associated with thousands of ulcers and stomach problems, including
between 10,000 and 20,000 deaths a year and more than 100,000
hospitalizations.
Analysts have projected that Cox-2 inhibitors could bring in $3 billion
annually by 2001, mainly because they cause fewer stomach problems.
Until now, Searle has had the Cox-2 market to itself in the U.S. But today,
an FDA advisory panel will consider whether to approve its first major
competitor, Merck & Co.'s Vioxx.
Dr. Geis, who declined to go into the details of any cases of death linked
to Celebrex, noted that many of the patients taking the drug have other
illnesses and are taking multiple medications. "These may contribute to any
potential side effects," he said. He also said the number of incidents is
relatively low, given the number of people taking the drug.
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