Diabetes drug Rezulin taken off market

Pill linked to 63 liver-poisoning deaths

March 23, 2000
Web posted at: 7:21 a.m. EST (1221 GMT)

In this story: 'Unacceptably high risk' FDA: Other drugs 'offer same benefits' Deaths linked to Rezulin RELATED STORIES, SITES

From staff and wire reports

WASHINGTON (CNN) -- Rezulin, a once-hailed diabetes drug used by about 750,000 Americans, has been withdrawn from the market after it was linked to at least 63 deaths from liver poisoning.

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The U.S. Food and Drug Administration, which requested the action Tuesday, urged Rezulin patients not to stop taking the drug without first contacting their doctors.

It said two newer drugs -- Avandia and Actos -- offer the same benefits as Rezulin with less risk.

While Rezulin's manufacturer agreed to remove it, a statement from Parke-Davis/Warner-Lambert indicated the company still had confidence in the drug, which was prescribed for Type 2 -- or adult onset -- diabetes patients who had not responded to other therapies.

In its statement, the drug-maker said it still thought the benefits of Rezulin (known generically as troglitazone) outweighed its risks but decided it "is in the best interest of patients to discontinue marketing Rezulin at this time."

"Repeated media reports sensationalizing the risks associated with Rezulin therapy have created an environment in which patients and physicians are simply unable to make well-informed decisions regarding the safety and efficacy of Rezulin," the statement said.

The FDA acted after mounting pressure from the Public Citizen Health Research Group, a consumer-advocacy organization, and even from some its own employees.

In one case, FDA medical officer Dr. Robert Misbin, one of Rezulin's reviewers within the agency, asked some members of Congress to investigate why his bosses had not pulled the pill from the market.

"I am writing to enlist your aid in convincing my superiors at FDA that Rezulin should be removed from the market because of its unacceptably high risk of causing liver failure," Misbin wrote earlier this month.

Until recently, FDA managers had insisted Rezulin benefited numerous diabetics whose disease isn't helped by any other drugs.

Dr. Sidney Wolfe, who heads Public Citizen and is a frequent critic of the FDA, said the drug should have been withdrawn long ago. He described Rezulin -- which went on the market in March 1997 -- as "one of the most dangerous drugs" on the market.

Glaxo Wellcome, which sold Rezulin in Britain, suspended sales of the drug there in December 1997.

Public Citizen first petitioned the FDA in July 1998 to remove Rezulin. "Easily more people have died between the time of our petition and when this belated ... (FDA) ... action was taken," Wolfe said.

According to the FDA announcement, a review of recent safety data showed that Rezulin was more toxic to the liver than the two newer drugs. "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.

Rosa Delia Valenzuela, left, died in Los Angeles in 1998 from liver failure after taking Rezulin

"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.

But Woodcock also stressed that although Actos and Avandia appeared safer on the liver than Rezulin, the agency is still watching for any serious side effects from either product.

"We are not saying we are confident these drugs will not cause liver toxicity," Woodcock said. "What we are saying is we believe they are safer" than Rezulin.

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

But since its introduction, Rezulin has been linked to 90 cases of liver failure. Of that total:

  • 63 people died (including three who underwent liver transplants)

  • 7 people who had a liver transplant survived

  • 10 people recovered without a transplant

  • 10 people are still suffering from liver failure

After the FDA began receiving reports of Rezulin patients suffering from liver failure, it ordered the manufacturer to put stronger liver-toxicity warnings on the drug . An FDA advisory committee also recommended that the drug be available to only a select group of patients -- those whose diabetes was not well-controlled by other drugs.

Correspondent Eileen O'Connor and The Associated Press and Reuters contributed to this report, written by Jim Morris

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Food and Drug Administration
  • Rezulin to be withdrawn from the market
  • Center for Drug Evaluation and Research
Parke-Davis
Warner-Lambert
  • Warner-Lambert voluntarily withdraws REZULIN
Public Citizen
  • REZULIN ALERT - Enforcement of Code of Ethics

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