ADVOCATES URGE FDA TO BAN DIABETES DRUG

WASHINGTON - Citing at least 26 worldwide deaths 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 liver 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 learn whether
Rezulin is harming the liver, so they 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 the FDA's Dr. Florence
Houn, who is overseeing Rezulin. "More education for health-care
providers is needed."

Manufacturer Parke-Davis will send letters Tuesday to 500,000 doctors
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.

Parke-Davis insisted the drug is safe when used properly.

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.

FDA 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,
Dr. Wolfe said.

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

1998 The Dallas Morning News

Checked-by: "Rich O'Grady"