ACTIVISTS: BAN DIABETES DRUG

WASHINGTON (AP) -- Citing at least 26 deaths worldwide from liver failure,
consumer advocates urged the government Monday to ban a diabetes drug
widely touted as a way to help some patients reduce their need for insulin
shots.

The call to ban Rezulin comes seven months after the drug was pulled off
the market in Britain because of its risks.

The Food and Drug Administration responded Monday that Rezulin offers an
important benefit for Type II diabetics who aren't adequately helped by
other drugs. The problem is that doctors aren't following repeated warnings
to closely test every diabetic to see if Rezulin is harming his or her
liver, so patients can stop taking the drug before it causes permanent
damage, the FDA said.

Deaths ``have persisted since the first warning, the majority of which
showed there was not proper monitoring,'' said FDA's Dr. Florence Houn, who
is overseeing Rezulin. ``More education for health-care providers is needed.''

The drug's manufacturer, Parke-Davis, will send letters today to 500,000
physicians saying the FDA last week upgraded its warning for Rezulin:
Doctors should test patients' livers for signs of toxicity monthly for the
first eight months of Rezulin therapy. But Parke-Davis insisted the drug is
safe when used properly.

``People have to remember there are 18 million patients with diabetes out
there, and they need treatment,'' said spokesman Stephen Mock.

But the consumer advocacy group Public Citizen said warnings aren't enough.

``How many more Americans will have to die or require liver transplants
before Parke-Davis and the FDA take action to protect people in this
country by banning the drug?'' wrote Public Citizen's Dr. Sidney Wolfe in a
petition filed Monday with the FDA.

46DA records dated June 5 show the agency has reports of at least 21
deaths among Rezulin users, 100 hospitalizations for liver toxicity and
three liver transplants in the first 15 months the drug was sold, Wolfe said.

Houn said 14 deaths linked to Rezulin involved Americans. The other seven
occurred in Japan, the only other country where Rezulin is sold, Wolfe
said. Since June 5, five more U.S. deaths have been sent to FDA for
evaluation, he added.

Last month, the National Institutes of Health abruptly canceled a study of
whether Rezulin could prevent Type II, or adult-onset, diabetes in
high-risk patients because one of the patients being studied died from
drug-induced liver toxicity.

The Rezulin concern comes a month after two other drugs were pulled off the
market when safety warnings failed to prevent patient injuries. The FDA
banned the painkiller Duract for causing liver failure after four deaths
and eight liver transplants. The blood-pressure drug Posicor was banned
after 24 deaths and 400 injuries when it interacted dangerously with other
medications.

Checked-by: Richard Lake