LOCAL PHARMACISTS TAKE REZULIN FROM SHELVES

Local pharmacists, like those across the country, removed the diabetes drug Rezulin from their shelves Wednesday, following a request from the Food and Drug Administration.

Rezulin, once cheered as offering new hope for some diabetes patients, was withdrawn from the market after being linked to at least 61 deaths from liver poisoning.

The FDA requested the drug be removed Tuesday, and the drug's manufacturers, Parke-Davis/Warner-Lambert of Morris Plains, N.J., agreed to the action.

Patients taking Rezulin should contact their doctors and discuss alternative treatments.

Rezulin, which went on the market in 1997, was prescribed for type 2, or adult onset, diabetes patients who had not responded to other therapies. It was used by about 750,000 Americans.

Wally Eck, a pharmacist at Jones Drug Store in Jackson, said he doesn't expect the removal of Rezulin to have much of an effect locally.

"It was prescribed quite frequently until findings came out about liver function problems" about a year ago, Eck said.

Since then, most doctors have switched their patients to other, newer drugs that, like Rezulin, restore the body's sensitivity to insulin but with less risk of liver toxicity, said John McMullin, a pharmacist at John's Pharmacy.

If customers come in to refill a prescription for Rezulin, their doctor will be called and asked if the prescription should be changed or if the person should go to the doctor for re-evaluation, said Jeff Smith, pharmacy manager at Healing Arts Pharmacy.

Prescriptions for Rezulin will not be refilled, the pharmacists said.

An FDA announcement said a review of recent safety data showed Rezulin more toxic to the liver than two newer drugs, Avandia and Actos, which have similar action.

"Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk," the FDA said.

"We are now confident that patients have safer alternatives in this important class of diabetes drugs," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

The action comes just days after the FDA announced that at least 61 deaths had been linked to Rezulin and an FDA physician had sent a letter asking Congress to help him persuade agency officials to remove the drug from the market.

A frequent critic of the FDA, Dr. Sidney Wolfe, said the drug should have been taken off the market long ago. He described Rezulin as "one of the most dangerous drugs" on the market.

Wolfe, director of the Public Citizen Health Research Group, a consumer advocacy group, said Rezulin "should have been long gone."

"The British government took it off the market a long time ago," he said. "The question is, why did it take the FDA so long to take it off the market?"

If the agency had acted earlier, some patients would still be alive, he said.

"It is just another example of how low the standards have gotten at FDA," he said.

Rezulin was well-received when it first went on the market in 1997 because it was the only drug available that restored the body's sensitivity to insulin.

Type 2 diabetes develops when the body no longer responds to insulin, a hormone required to process sugar in the blood.

Doctors hailed Rezulin because it promised treatment for patients who failed other therapies. Untreated diabetes can cause heart and kidney failure, blindness and other problems.

After Rezulin was on the market, the FDA began receiving reports of patients suffering from liver failure after taking the drug.

The FDA ordered Parke-Davis to put stronger liver toxicity warnings on the drug and an advisory committee recommended the drug be available to only a select group of patients those whose diabetes was not well-controlled by other drugs.

Eventually, at least 61 patients died of liver failure while taking Rezulin, and another seven required liver transplants.

Avandia, manufactured by SmithKline Beecham, and Actos, made by Takeda Pharmaceuticals and marketed by Eli Lilly & Co., were approved last year as alternative drugs to Rezulin. The agency said Tuesday that after nine months on the market, it is clear that the newer drugs "have less risk of severe liver toxicity than Rezulin."

The Associated Press contributed to this report.